Psychoeducation [Brief] for People with Serious Mental Illness

Psychoeducation (brief) for people with serious mental illness (Review)

Zhao S, Sampson S, Xia J, Jayaram MB

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 4 http://www.thecochranelibrary.com

HEADER...... 1 ABSTRACT ...... 1 PLAINLANGUAGESUMMARY ...... 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON ...... 4 BACKGROUND ...... 7 OBJECTIVES ...... 7 METHODS ...... 8 RESULTS...... 14 Figure1...... 15 Figure2...... 18 Figure3...... 19 ADDITIONALSUMMARYOFFINDINGS ...... 27 DISCUSSION ...... 30 AUTHORS’CONCLUSIONS ...... 32 ACKNOWLEDGEMENTS ...... 33 REFERENCES ...... 34 CHARACTERISTICSOFSTUDIES ...... 40 DATAANDANALYSES...... 78 Analysis 1.1. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance...... 84 Analysis 1.2. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With medication - partial compliance (medium term)...... 85 Analysis 1.4. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 4 Compliance: 1d. With medication - very good/ good compliance (numberic compliance scale). . 86 Analysis 1.5. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 5 Compliance: 2a. With follow-up - loss to follow-up for any reason...... 87 Analysis 1.6. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 6 Relapse: 1. Relapse for any reason...... 89 Analysis 1.7. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 7 Relapse: 2. Relapse with readmission...... 90 Analysis 1.8. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales...... 91 Analysis 1.11. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 11 Knowledge: 2. Average endpoint scores (SAUMD, high = poor) (short term)...... 92 Analysis 1.12. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 12 Global state: 2. Average endpoint scale score...... 93 Analysis 1.13. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 13 Service utilisation: rehospitalisation...... 94 Analysis 1.14. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 14 Mental state: 1a. Global - average total endpoint scale scores (BPRS, high = poor)...... 95 Analysis 1.15. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 15 Mental state: 1b. Global - average change scale scores (GWB/SES, high = good) (medium term). 96 Analysis 1.17. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 17 Mental state: 2a. Speciﬁc symptoms - short term...... 97 Analysis 1.18. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 18 Mental state: 2b. speciﬁc symptoms - average total endpoint scale score (high = poor) (short term). 98 Analysis 1.20. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 20 Social functioning: 1a. Average change scores on various scales (high = poor) (medium term). . . 99 Analysis 1.21. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 21 Expressed emotion: Participants with high EE relatives(FQ)...... 99

Psychoeducation (brief) for people with serious mental illness (Review) i Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.22. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 22 Expressed emotion for relatives: Average change scores on FQ scales (high = good)...... 100 Analysis 1.23. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good)...... 100 Analysis 1.24. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 24 Quality of life: 1b. Average endpoint scores (FAD, high=poor)...... 101 Analysis 1.26. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 26 Satisfaction with mental health services: 1. Average change score (VSS, high = good) (short term). 102 Analysis 1.27. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 27 Satisfaction with mental health services: 2. Average change (VSS Scale, high = good) (long term at 1 year)...... 103 Analysis 1.28. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 28 Patients’ satisfaction with mental health services: average endpoint scores (CSQ, high = good) (short term)...... 103 Analysis 1.29. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome29Adverseevent:Death...... 104 Analysis 2.1. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Compliance: With medication (numberic compliance scale, high = good)...... 105 Analysis 2.2. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for anyreason(mediumterm)...... 106 Analysis 2.3. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 3 Service utilisation: hospitalisation(longterm)...... 106 Analysis 2.4. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 4 Mental state: Speciﬁc - average endpoint PANSS scores (high = poor)...... 107 Analysis 2.5. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 5 Quality of life: Average endpoint MSQoL-54 score (high = good)...... 108 Analysis 3.1. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance...... 109 Analysis 3.2. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With follow up - losstofollow-upforanyreason...... 110 Analysis 3.3. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 3 Relapse: 1. Relapse for any reason. 111 Analysis 4.1. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Relapse: Relapse for any reason (medium term)...... 112 Analysis 4.2. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term)-without assumption. 113 Analysis 5.1. Comparison 5 SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance...... 113 ADDITIONALTABLES...... 114 CONTRIBUTIONSOFAUTHORS ...... 116 DECLARATIONSOFINTEREST ...... 116 SOURCESOFSUPPORT ...... 117 DIFFERENCES BETWEEN PROTOCOL AND REVIEW ...... 117

Psychoeducation (brief) for people with serious mental illness (Review) ii Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Psychoeducation (brief) for people with serious mental illness

Sai Zhao1, Stephanie Sampson2, Jun Xia3, Mahesh B Jayaram4

1Tianjin University of Traditional Chinese Medicine, Tianjin, China, Systematic Review Solutions Ltd, Yan Tai, China. 2The University of Nottingham, Nottingham, UK. 3Cochrane Schizophrenia Group, The University of Nottingham, Nottingham, UK. 4Department of Psychiatry, Melbourne Neuropsychiatry Centre, Melbourne, Australia

Contact address: Sai Zhao, Tianjin University of Traditional Chinese Medicine, Tianjin, China, Systematic Review Solutions Ltd, 5-6 West Tashan Road, Yan Tai, 264000, China. [email protected].

Editorial group: Cochrane Schizophrenia Group. Publication status and date: New, published in Issue 4, 2015. Review content assessed as up-to-date: 4 February 2014.

Citation: Zhao S, Sampson S, Xia J, Jayaram MB. Psychoeducation (brief) for people with serious mental illness. Cochrane Database of Systematic Reviews 2015, Issue 4. Art. No.: CD010823. DOI: 10.1002/14651858.CD010823.pub2.

ABSTRACT

Background

Those with serious/severe mental illness, especially schizophrenia and schizophrenic-like disorders, often have little to no insight regarding the presence of their illness. Psychoeducation may be deﬁned as the education of a person with a psychiatric disorder regarding the symptoms, treatments, and prognosis of that illness. Brief psychoeducation is a short period of psychoeducation; although what constitutes ’brief psychoeducation’ can vary. A previous systematic review has shown that the median length of psychoeducation is around 12 weeks. In this current systematic review, we deﬁned ’brief psychoeducation’ as programmes of 10 sessions or less.

Objectives

To assess the efﬁcacy of brief psychoeducational interventions as a means of helping severely mentally ill people when added to ’standard’ care, compared with the efﬁcacy of standard care alone.

The secondary objective is to investigate whether there is evidence that a particular kind (individual/ family/group) of brief psychoeducational intervention is superior to others.

Search methods

We searched the Cochrane Schizophrenia Group register September 2013 using the phrase:

[*Psychoeducat* in interventions of STUDY]. Reference lists of included studies were also inspected for further relevant studies. We also contacted authors of included study for further information regarding further data or details of any unpublished trials.

Selection criteria

All relevant randomised controlled trials (RCTs) comparing brief psychoeducation with any other intervention for treatment of people with severe mental illness. If a trial was described as ’double blind’ but implied randomisation, we entered such trials in a sensitivity analysis.

Psychoeducation (brief) for people with serious mental illness (Review) 1 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Data collection and analysis At least two review authors extracted data independently from included papers. We contacted authors of trials for additional and missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data. For continuous data, we calculated the mean difference (MD), again with 95% CIs. We used a fixed-effect model for data synthesis, and also assessed data using a random-effects model in a sensitivity analysis. We assessed risk of bias for each included study and created ’Summary of findings’ tables using GRADE (Grading of Recommendations Assessment, Development and Evaluation). Main results We included twenty studies with a total number of 2337 participants in this review. Nineteen studies compared brief psychoeducation with routine care or conventional delivery of information. One study compared brief psychoeducation with cognitive behavior therapy. Participants receiving brief psychoeducation were less likely to be non-compliant with medication than those receiving routine care in the short term (n = 448, 3 RCTs, RR 0.63 CI 0.41 to 0.96, moderate quality evidence) and medium term (n = 118, 1 RCT, RR 0.17 CI 0.05 to 0.54, low quality evidence). Compliance with follow-up was similar between the two groups in the short term (n = 30, 1 RCT, RR 1.00, CI 0.24 to 4.18), medium term (n = 322, 4 RCTs, RR 0.74 CI 0.50 to 1.09) and long term (n = 386, 2 RCTs, RR 1.19, CI 0.83 to 1.72). Relapse rates were significantly lower amongst participants receiving brief psychoeducation than those receiving routine care in the medium term (n = 406, RR 0.70 CI 0.52 to 0.93, moderate quality evidence), but not in the long term. Data from a few individual studies supported that brief psychoeducation: i) can improve the long-term global state (n = 59, 1 RCT, MD -6.70 CI -13.38 to -0.02, very low quality evidence); ii) promote improved mental state in short term (n = 60, 1 RCT, MD -2.70 CI -4.84 to -0.56,low quality evidence) and medium term; iii) can lower the incidence and severity of anxiety and depression. Social function such as rehabilitation status (n = 118, 1 RCT, MD -13.68 CI -14.85 to -12.51, low quality evidence) and social disability (n = 118, 1 RCT, MD -1.96 CI -2.09 to -1.83, low quality evidence) were also improved in the brief psychoeducation group. There was no difference found in quality of life as measured by GQOLI-74 in the short term (n = 62, 1 RCT, MD 0.63 CI -0.79 to 2.05, low quality evidence), nor the death rate in either groups (n = 154, 2 RCTs, RR 0.99, CI 0.15 to 6.65, low quality evidence). Authors’ conclusions Based on mainly low to very low quality evidence from a limited number of studies, brief psychoeducation of any form appears to reduce relapse in the medium term, and promote medication compliance in the short term. A brief psychoeducational approach could potentially be effective, but further large, high-quality studies are needed to either confirm or refute the use of this approach.

PLAIN LANGUAGE SUMMARY The effectiveness of brief psychoeducation (10 sessions or less) for people with serious mental illness Review question. To investigate the effectiveness of brief psychoeducation compared with standard care as a means of helping people with serious mental illness. To investigate whether any kind (individual/ family/group) of brief psychoeducation is better than others. Background. Schizophrenia is a serious, long-term mental illness where people experience hallucinations and/or delusions and are often unable to distinguish these experiences from reality. Hearing voices and seeing things can be disturbing, confusing and frightening and can lead to changes in behaviour. It is suggested that insight into the illness can help people to understand the need for treatment and subsequently improve the prognosis. However, the nature of schizophrenia is such that it alters peoples thought processes and they are often unable to have insight into their illness. The stigma of having a mental illness can also inﬂuence a person’s willingness to seek or take treatments. Effective education of people with schizophrenia can improve insight and understanding. Psychoeducation programmes have been developed, speciﬁcally aimed at people with mental health problems. It is not simply providing information to patients. Rather, it is a form of empowering training targeted at promoting awareness and providing tools to manage, cope and live with a mental illness. However, psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) 2 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. can be time consuming; brief psychoeducation has been developed as a possible solution to this problem. In this review the authors deﬁned brief psychoeducation to be a psychoeducation programme of 10 sessions or less. Study characteristics. The review authors searched for randomised trials in 2013 and found 20 relevant studies with 2337 participants. Half of the studies were carried out in China. These trials randomised people to receive either brief psychoeducation sessions (these ranged from one-day psychoeducation to eight sessions of psychoeducation over a period of one year) or routine care. Key results. Based on information from a limited number of studies, brief psychoeducation does seem to reduce relapse and encourage people to take their medication. Those receiving brief psychoeducation also have more favourable results for mental state and social functioning. Quality of the evidence. Although initial results are encouraging, most information and data for the main outcomes of interest, were rated as low or very low quality, and the number of trials providing useful data is small. Until further large, high-quality studies become available, the usefulness of brief psychoeducation remains debatable. Ben Gray, Senior Peer Researcher, McPin Foundation.http://mcpin.org/

Psychoeducation (brief) for people with serious mental illness (Review) 3 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. oyih 05TeCcrn olbrto.Pbihdb J by Published Collaboration. Cochrane The ill 2015 mental © serious Copyright with people for (brief) Psychoeducation SUMMARYOFFINDINGSFORTHEMAINCOMPARISON [Explanation]

ANY FORM OF PSYCHOEDUCATION compared with ROUTINE CARE/INFORMATION for people with serious mental illness

Patient or population: people with serious mental illness Settings: China (54%); Germany (14%); Denmark (8%); Pakistan (8%); Scotland (8%); Malaysia (8%). Intervention: ANY FORM OF PSYCHOEDUCATION Comparison: ROUTINE CARE/INFORMATION

Outcomes Illustrative comparative risks* (95% CI) Relative effect No of Participants Quality of the evidence Comments (95% CI) (studies) (GRADE)

Assumed risk Corresponding risk

es(Review) ness ANY FORM OF BRIEF

h ie os Ltd. Sons, & Wiley ohn PSYCHOEDUCATION

Compliance: 1a. With Study population RR 0.63 448 ⊕⊕⊕ medication - non-com- (0.41 to 0.96) (3 studies) moderate2 pliance - short term 205 per 10001 129 per 1000 Follow-up: 12 weeks (84 to 197)

Moderate

137 per 10001 86 per 1000 (56 to 132)

Relapse: 1. Relapse for Study population RR 0.7 406 ⊕⊕⊕ any reason - medium (0.52 to 0.93) (4 studies) moderate4 term 354 per 10003 248 per 1000 Follow-up: 12-52 weeks (184 to 329)

Moderate

351 per 1000 3 246 per 1000 (183 to 326) 4 oyih 05TeCcrn olbrto.Pbihdb J by Published Collaboration. Cochrane The ill 2015 mental © serious Copyright with people for (brief) Psychoeducation

Global state: 2. Average The mean global state: The mean global state: 101 ⊕ endpoint scale score - medium term in the con- 2. average endpoint scale (2 studies) very low5,6,7 medium term (GAF/GAS, trol groups was score - medium term high = good) -56.6 points (GAF/GAS, high = good) Follow-up: 12-52 weeks in the intervention groups was 0.5 lower (5.48 lower to 4.47 higher)

Mental state: 1a. Global The mean mental state: The mean mental state: 60 ⊕⊕ - average total endpoint short term in the control 1a. global - average to- (1 study) very low5,8,9 scale scores (BPRS, group was 23.33 points tal endpoint scale scores

es(Review) ness high = poor) - short term (BPRS, high = poor) - Follow-up: up to 12 short term in the interven- h ie os Ltd. Sons, & Wiley ohn weeks tion groups was 2.7 lower (4.84 to 0.56 lower)

Social functioning: 1a. The mean social function- The mean social function- 118 ⊕⊕ Average change scores ing: medium term in the ing: medium term in the (1 study) low8,9 on various scales - control groups was intervention groups was medium term (high = -0.29 points 1.96 lower poor) - SDSS (1.83 to 2.09 lower) Follow-up: 12-52 weeks

Quality of life: 1a. Av- The mean quality of life: The mean quality of life: 62 ⊕⊕ erage endpoint scores short term in the control short term in the interven- (1 study) low8,9 (GQOLI-74, high = groups was tion groups was good) - short term 16.72 points 0.63 higher Follow-up: up to 12 (0.79 lower to 2.05 weeks higher)

Adverse event: Death - Study population RR 0.99 154 ⊕⊕ medium term (0.15 to 6.65) (2 studies) low5,7 Follow-up: 12-52 weeks 5 oyih 05TeCcrn olbrto.Pbihdb J by Published Collaboration. Cochrane The ill 2015 mental © serious Copyright with people for (brief) Psychoeducation

13 per 100010 13 per 1000 (2 to 85)

Moderate

23 per 100010 23 per 1000 (3 to 153)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence

es(Review) ness High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. h ie os Ltd. Sons, & Wiley ohn Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

1Assumed risk: median control group risk presented from studies, as little variation in baseline risk across studies (13.7%). 2 Risk of bias: rated ’serious’ - two included studies rated as a ’high’ risk of bias across at least one of the ’Risk of bias’ domains, including selective reporting and incomplete outcome data. 3Assumed risk: median control group risk presented from studies, as little variation in baseline risk across studies (35.1%). 4 Risk of bias: rated ’serious’ - three included studies rated as a ’unclear’ risk of bias across at least one of the ’Risk of bias’ domains, including selective reporting and incomplete outcome data. 5 Risk of bias: rated ’serious’ - one included study rated as a ’high’ risk of bias across at least one of the risk of bias domains, including incomplete outcome data. 6 Inconsistency: rated as ’serious’ - a considerable heterogeneity was detected (I2 = 58%). 7 Imprecision: rated ’serious’ - confidence intervals for best estimate of effect include both no effect and appreciable benefit/ harm. 8 Imprecision: rated as ’serious’, too small sample size. 9 We strongly suggested a publication bias because only one studies was included. 10Assumed risk: median control group risk presented from studies, as little variation in baseline risk across studies (2.3%). 6 BACKGROUND psychiatric condition, and changing behaviours and attitudes related to the condition (Colom 2011). Patient education can take a variety of forms and length. Some are as brief as one session Description of the condition (Razali 1997), others are as long as 18 months (Herz 2000). A previous systematic review has shown that the median length of The term ’serious’ or ’severe’ mental illness is widely used by men- psychoeducation is around 12 weeks (Xia 2011). Therefore, for tal health professionals, but there is no internationally agreed def- psychoeducation to be considered ’brief’ we have used a cut-off of inition for the term, and limited consistency between definitions. 10 sessions or less. The terms ’patient education’, ’patient teach- The definition of severe mental illness which is most representa- ing’, and ’patient instruction’ have also been used for this process. tive of definitions used in research is that of the National Institute All imply that there is a focus on knowledge. The purpose of pa- of Mental Health (NIMH) (Schinnar 1990), which has three di- tient education, ultimately, is to enable the patient to engage in mensions. behaviour change and build skills for illness management (Chien 1. Clinical diagnosis: a diagnosis of non-organic psychosis or 2013c). The goal may be to try to prevent hospitalisation or to personality disorder. manage the illness or condition to help the patient attain her/his 2. Chronicity: a two-year, or longer history of mental illness or maximum degree of health and well-being. treatment. 3. Disability: functional impairment, limiting one or more major life activities (National Institute of Mental Health 1987). The UK Quality and Outcomes Framework, which encourages How the intervention might work General Practices to maintain registers of patients with severe men- Education is a gradual process by which a person gains knowledge tal illness, uses the following inclusion criteria, based on diagnosis and understanding through learning. Learning, however, involves alone: schizophrenia, bipolar disorder and other psychoses (QOF more than knowledge and, according to Rankin 1996, it can in- 2009). This is representative of definitions used by the UK De- volve cognitive, affective and psychomotor processes. Learning im- partment of Health, and used in practice. Ruggeri 2000 suggested plies changes in behaviour, skill or attitude (Falvo 1994). Patient that the total worldwide population-based annual prevalence of education can take a variety of forms depending upon the abilities serious mental illness is approximately two per thousand. Current and interest of the patient and family. For example, the education mental health policy objectives include ensuring optimal quality may take place in small groups or on a one-to-one basis; it may of life for those with severe mental illness, and providing evidence- involve the use of videotapes or pamphlets or a combination of based approaches to give people the greatest choice and control these. over their own lives (DoH 2011). Those with severe mental illness, especially schizophrenia and schizophrenic-like disorders, often have little to no insight regarding the presence of their illness (McCormack 2013). This means Why it is important to do this review that people with severe mental illness will not understand that they Proposed benefits of psychoeducation as a psychological interven- are ill in the same way that third party observers do. The lack of tion are that it is clinically focused, straightforward to deliver, and understanding of their illness, ultimately leads to poor treatment does not require long and complex training (Colom 2011). compliance and can result in relapse and repeated hospitalisation However, a key drawback is that psychoeducation tradition- (Gerhardstein 2013). Some people may feel stigmatised by their ally places demands upon therapist time, with programmes of- illness and may deny its existence, whereas others have a true lack ten comprising many modules. A recent narrative literature re- of understanding (Harvey 2013); both, ultimately increase non- view has suggested that shorter psychoeducation programmes or compliance. Non-compliance is even more of a problem when ’brief psychoeducation’ may have long-term positive outcomes in people are living in the community and is also often related to the schizophrenia (Rummel-Kluge 2008). adverse effects of medication, as well as a lack of adequate knowl- It is therefore important to look at brief psychoeducation pro- edge about medication (Antai-Otong 1989). grammes.

Description of the intervention

Psychoeducation may be defined as the education of a person with OBJECTIVES a psychiatric disorder regarding the symptoms, treatments, and prognosis of that illness. It is not simply ’providing information’, To assess the efficacy of brief psychoeducational interventions as but rather empowering training for patients targeted at promoting a means of helping severely mentally ill people when added to awareness, providing tools to manage, cope and live with a chronic ’standard’ care, compared with the efficacy of standard care alone.

Psychoeducation (brief) for people with serious mental illness (Review) 7 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. The secondary objective is to investigate whether there is evidence a multidimensional viewpoint, including familial, social, biologi- that a particular kind (individual/ family/group) of brief psychoe- cal and pharmacological perspectives. Patients were provided with ducational intervention is superior to others. support, information and management strategies. Interventions including elements of behavioural training, such as social skills or life-skills training, as well as education, performed by patient METHODS peers, were excluded from this review. Staff education studies were also excluded. 2. Standard care was deﬁned as the normal level of psychiatric care provided in the area where the trial was carried out. Criteria for considering studies for this review

Types of outcome measures Types of studies We divided all outcomes into short term (up to 12 weeks), medium All relevant randomised controlled trials. If a trial was described as term (13-52 weeks) or long term (over 52 weeks), and were inter- ’double blind’ but implied randomisation, we included such trials preted as defined by each of the studies. in a sensitivity analysis (see Sensitivity analysis). If their inclusion did not result in a substantive difference, they remained in the analyses. If their inclusion did result in important clinically sig- Primary outcomes nificant but not necessarily statistically significant differences, we did not add the data from these lower quality studies to the results of the better trials, but presented such data within a subcategory. 1. Compliance We excluded quasi-randomised studies, such as those allocating by alternate days of the week. Where people were given additional 1.1 Compliance with medication treatments within brief psychoeducation, we only included data if 1.2 Compliance with follow-up the adjunct treatment was evenly distributed between groups and it was only the brief psychoeducation that was randomised. 2. Relapse

Types of participants Adults suffering from severe/serious mental illness as deﬁned by Secondary outcomes National Institute of Mental Health 1987. In the absence of a formal diagnosis, we included people with illness such as schizophrenia, schizophrenia-like disorders, bipolar disorder, depression with 3. Knowledge psychotic features and/or personality disorder. Studies involving 3.1 Improvement of understanding of his/her illness and need for people with dual diagnosis of severe mental illness plus substance treatment - recipient/family member abuse were also included. However, trials involving particIpants 3.2 Level of knowledge about expected and undesired effects of with substance abuse alone were not included. Studies involving medication - recipient/family member people with dementia or mental retardation were also excluded, as these illnesses are not considered as severe mental disorders. We included studies involving people with a range of severe mental 4. Behaviour illness diagnoses but only where the majority of people had a diagnosis of schizophrenia. A majority of the study participants were 4.1 Level of psychiatric symptoms required to be within the age range 18 to 65 years. 4.2 Symptom control skills 4.3 Problem-solving skills 4.4 Social skills Types of interventions 1. All didactic interventions of psychoeducation or patient teaching, involving individuals or groups, considered to be ’brief’ were 5. Global state included. For the purpose of this review, programmes of 10 ses- 5.1 Overall improvement sions or less were considered as ’brief’. 5.2 Use of additional medication We deﬁned psychoeducational interventions as any group or in- 5.3 Average endpoint in global state score dividual programme involving interaction between information 5.4 Average change in global state scores provider and patient. These programmes addressed the illness from 5.5 Average dose of drug

Psychoeducation (brief) for people with serious mental illness (Review) 8 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 6. Global functioning 13. Adverse effects/event 6.1 Clinically important change in general functioning 13.1 Clinically important general adverse effects 6.2 Any change in general functioning 13.2 Any general adverse effects 6.3 Average endpoint in general functioning score 13.3 Any serious, specific adverse effects 6.4 Average change in general functioning scores 13.4 Average endpoint general adverse effect score 13.5 Average change in general adverse effect scores 13.6 Clinically important change in specific adverse effects 7. Service utilisation 13.7 Any change in specific adverse effects 13.8 Average endpoint specific adverse effects 7.1 Use of outpatient treatment 13.9 Average change in specific adverse effects 7.2 Length of hospitalisation

14. Health economic outcomes 8. Mental state 14.1 Treatment costs 8.1 Clinically important change in general mental state 8.2 Any change in general mental state 15. ’Summary of findings’ table 8.3 Average endpoint in general mental state score We used the GRADE approach to interpret findings (Schünemann 8.4 Average change in general mental state scores 2008) and used GRADE profiler (GRADEPRO) to import data from RevMan 5.1 (Review Manager) to create ’Summary of findings’ tables. These tables provided outcome-specific information 9. Social functioning concerning the overall quality of evidence from each included 9.1 Clinically important change in social functioning study in the comparison, the magnitude of effect of the interven- 9.2 Any change in social functioning tions examined, and the sum of available data on all outcomes we 9.3 Average endpoint in social functioning score rated as important to patient-care and decision making. We se- 9.4 Average change in social functioning scores lected the following main outcomes for inclusion in the ’Summary of findings’ table: 1. Compliance - compliance with medication 10. Expressed emotion 2. Relapse - as defined in each study 10.1 Clinically important change in expressed emotion 3. Global state - overall improvement 10.2 Any change in expressed emotion 4. Mental state - clinically important change in general mental 10.3 Average endpoint general expressed emotion score state 10.4 Average change in general expressed emotion scores 5. Social function - clinically important change in social functioning 6. Quality of life - clinically important change in quality of life 11. Quality of life 7. Adverse effects - clinically important general adverse effects 11.1 Clinically important change in quality of life 11.2 Any change in quality of life 11.3 Average endpoint quality of life score Search methods for identification of studies 11.4 Average change in quality of life scores 11.5 Clinically important change in specific aspects of quality of Electronic searches life 11.6 Any change in specific aspects of quality of life We searched the Cochrane Schizophrenia Group register Septem- 11.7 Average endpoint specific aspects of quality of life ber 2013 using the phrase: 11.8 Average change in specific aspects of quality of life [*Psychoeducat* in interventions of STUDY]. This register is compiled by systematic searches of major databases, hand searches and conference proceedings (see Group Module). 12. Satisfaction with care 12.1 Clinically important change in satisfaction Searching other resources 12.2 Any change in satisfaction 12.3 Average endpoint in satisfaction score 1. Reference searching 12.4 Average change in satisfaction scores

Psychoeducation (brief) for people with serious mental illness (Review) 9 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. We inspected references of all included studies for further relevant 2.2 Scale-derived data studies. We included continuous data from rating scales only if:

a) the psychometric properties of the measuring instrument have 2. Personal contact been described in a peer-reviewed journal (Marshall 2000); and We contacted the ﬁrst author of each included study for informa- b) the measuring instrument has not been written or modiﬁed by tion regarding unpublished trials. If authors responded we noted one of the trialists for that particular trial. their responses in Characteristics of included studies. Ideally, the measuring instrument should either be i. a self-report or ii. completed by an independent rater or relative (not the Data collection and analysis therapist). We realise that this is not often reported clearly, in Description of studies we noted if this was the case or not.

Selection of studies 2.3 Endpoint versus change data Review author SZ inspected citations from the searches and iden- There are advantages of both endpoint and change data. Change tified relevant abstracts. A random 20% sample was independently data can remove a component of between-person variability from re-inspected by JX to ensure reliability. Where disputes arose, the the analysis. On the other hand, calculation of change needs two full report was acquired for more detailed scrutiny. Full reports assessments (baseline and endpoint), which can be difficult in un- of the abstracts meeting the review criteria were obtained and in- stable and difficult to measure conditions such as schizophrenia. spected by SZ. A random 20% of reports were re-inspected by JX We decided primarily to use endpoint data, and only use change in order to ensure reliable selection. Where it was not possible to data where the former were not available. Had we extracted end- resolve disagreement by discussion, we contacted the authors of point and change data from the same scales, they would have been the study for clarification. combined in the analysis through use of standardised mean differences (SMD) rather than mean differences (MD) throughout (Higgins 2011). Data extraction and management 2.4 Skewed data Continuous data on clinical and social outcomes are often not 1. Extraction normally distributed. To avoid the pitfall of applying parametric Review authors SS and AA (working as a team) extracted data tests to non-parametric data, we aimed to apply the following from all included studies parallel to SZ . In addition, to ensure standards to all data before inclusion: reliability, JX independently extracted data from a random sample of these studies, comprising 10% of the total. Again, any dis- a) standard deviations (SDs) and means were reported in the paper agreement was discussed, decisions documented and, if necessary, or obtainable from the authors; authors of studies were contacted for clarification. We planned b) when a scale starts from the finite number zero, the SD, when to consult MBJ for clarification of any remaining problems , but multiplied by two, is less than the mean (as otherwise the mean is we did not request his assistance during this process Where data unlikely to be an appropriate measure of the centre of the distri- were presented only in graphs and figures, we attempted to ex- bution, (Altman 1996); tract the data whenever possible and include such data but only c) if a scale started from a positive value (such as the Positive where the review authors independently found the same result. and Negative Syndrome Scale (PANSS), (Kay 1986)), which can We attempted to contact authors through an open-ended request have values from 30 to 210), the calculation described above was in order to obtain missing information or for clarification when- modified to take the scale starting point into account. In these ever necessary. Where studies were multi-centre, where possible, cases skew is present if 2 SD > (S-S min), where S is the mean we extracted data relevant to each component centre separately. score and ’S min’ is the minimum score. Endpoint scores on scales often have a finite start and end point and these rules can be applied. Skewed data pose less of a problem 2. Management when looking at means if the sample size is large (> 200) and we entered these into the syntheses. We presented skewed endpoint data from studies of less than 200 participants as ’other data’ within 2.1 Forms the data and analyses section rather than enter such data into a We extracted data onto standard, simple forms. statistical analyses.

Psychoeducation (brief) for people with serious mental illness (Review) 10 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Measures of treatment effect When continuous data are presented on a scale that includes a possibility of negative values (such as change data), it is difficult to tell whether data are skewed or not. We presented and entered 1. Binary data change data into analyses. For binary outcomes, we calculated a standard estimation of the risk ratio (RR) and its 95% confidence interval (CI). It has been 2.5 Common measure shown that RR is more intuitive (Boissel 1999) than odds ratios and that odds ratios tend to be interpreted as RR by clinicians To facilitate comparison between trials, we intended to convert (Deeks 2000). The Number Needed to Treat/Harm (NNT/H) variables that can be reported in different metrics, such as days in statistic with its CIs is intuitively attractive to clinicians but is hospital (mean days per year, per week or per month) to a common problematic both in its accurate calculation in meta-analyses and metric (e.g. mean days per month) - however, no such data were interpretation (Hutton 2009). For binary data presented in the identified. Summary of findings for the main comparison, where possible, we calculated illustrative comparative risks. 2.6 Conversion of continuous to binary

Where possible, in future updates of this review, efforts will be 2. Continuous data made to convert outcome measures to dichotomous data. This can be done by identifying cut-off points on rating scales and dividing For continuous outcomes, we estimated mean difference (MD) participants accordingly into ’clinically improved’ or ’not clinically between groups. We preferred not to calculate effect size measures improved’. It is generally assumed that if there is a 50% reduction (standardised mean difference SMD). Had scales of very consid- in a scale-derived score such as the Brief Psychiatric Rating Scale erable similarity been used, we would have presumed there was a (BPRS, Overall 1962) or the PANSS (Kay 1986), this could be small difference in measurement, and we would have calculated considered as a clinically signiﬁcant response (Leucht 2005; Leucht effect size and transformed the effect back to the units of one or 2005a). If data based on these thresholds are not available, we will more of the speciﬁc instruments. use the primary cut-off presented by the original authors. Unit of analysis issues 2.7 Direction of graphs

Where possible, we entered data in such a way that the area to 1. Cluster trials the left of the line of no effect indicates a favourable outcome for brief psychoeducation. Where keeping to this makes it impossible Studies increasingly employ ’cluster randomisation’ (such as ran- to avoid outcome titles with clumsy double-negatives (e.g. ’Not domisation by clinician or practice) but analysis and pooling of improved’), we reported data where the left of the line indicates clustered data poses problems. Firstly, authors often fail to account an unfavourable outcome. This is noted in the relevant graphs. for intra-class correlation in clustered studies, leading to a ’unit of analysis’ error (Divine 1992) whereby P values are spuriously low, CIs unduly narrow and statistical significance overestimated. This Assessment of risk of bias in included studies causes type I errors (Bland 1997; Gulliford 1999). Review authors SZ and MJ worked independently to assess risk of No cluster trials were identified in this review’s trial search. bias by using criteria described in the Cochrane Handbook for Sys- In future versions, if cluster studies are included, where clustering temic reviews of Interventions (Higgins 2011) to assess trial quality. is not accounted for in primary studies, we will present data in This set of criteria is based on evidence of associations between a table, with a (*) symbol to indicate the presence of a probable overestimate of effect and high risk of bias of the article such as se- unit of analysis error and seek to contact first authors of studies to quence generation, allocation concealment, blinding, incomplete obtain intra-class correlation coefficients (ICCs) for their clustered outcome data and selective reporting. data and to adjust for this by using accepted methods (Gulliford If the raters disagreed, the final rating was made by consensus, with 1999). Where clustering has been incorporated into the analysis of the involvement of another member of the review group. Where primary studies, we will present these data as if from a non-cluster inadequate details of randomisation and other characteristics of randomised study, but adjust for the clustering effect. We have trials were provided, we contacted the authors of the studies in or- sought statistical advice and have been advised that the binary data der to obtain further information. Had non-concurrence in qual- as presented in a report should be divided by a ’design effect’. This ity assessment been found, this would have been reported, and all is calculated using the mean number of participants per cluster disputes would have been resolved by discussion. (m) and the ICC [Design effect = 1+(m-1)*ICC] (Donner 2002). The level of risk of bias was noted in both the text of the review If the ICC is not reported we will assume it to be 0.1 (Ukoumunne and in the Summary of findings for the main comparison. 1999).

Psychoeducation (brief) for people with serious mental illness (Review) 11 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. If cluster studies have been appropriately analysed taking into ac- and adverse effects. For these outcomes, the rate of those who stay count ICCs and relevant data documented in the report, synthesis in the study - in that particular arm of the trial - were used for with other studies will be possible using the generic inverse vari- those who did not. We undertook a sensitivity analysis to test how ance technique. prone the primary outcomes were to change when data only from people who completed the study to that point were compared to the ITT analysis using the above assumptions. 2. Cross-over trials Due to the nature of the intervention, cross-over trials were not anticipated, nor identified in our search. However, in future versions of this review, it will be considered that a major concern of 3. Continuous cross-over trials is the carry-over effect. It occurs if an effect (e.g. pharmacological, physiological or psychological) of the treatment in the first phase is carried over to the second phase. As a conse- 3.1 Attrition quence, on entry to the second phase the participants can differ systematically from their initial state despite a wash-out phase. For In the case where attrition for a continuous outcome was between the same reason cross-over trials are not appropriate if the condi- 0% and 50%, and data only from people who complete the study tion of interest is unstable (Elbourne 2002). As both effects are to that point are reported, we reproduced these. very likely in severe mental illness, we will only use data of the first phase of cross-over studies. 3.2 Standard deviations 3. Studies with multiple treatment groups If standard deviations (SDs) were not reported, we first tried to Where a study involved more than two treatment arms, if rele- obtain the missing values from the authors. If not available, where vant, the additional treatment arms were presented in the compar- there were missing measures of variance for continuous data, but isons. If data were binary, these were simply added and combined an exact standard error (SE) and CIs available for group means, and within the two-by-two table. If data were continuous, we com- either ’a P’ value or ’t’ value available for differences in mean, we bined data following the formula in section 7.7.3.8 (Combining calculated them according to the rules described in the Cochrane groups) of the Cochrane Handbook for Systemic reviews of Interven- Handbook for Systemic reviews of Interventions (Higgins 2011). tions (Higgins 2011). Where the additional treatment arms are not When only the SE was reported, SDs were calculated by the for- relevant, we did not use these data. mula SD = SE * square root (n). Chapters 7.7.3 and 16.1.3 of the Cochrane Handbook for Systemic reviews of Interventions (Higgins Dealing with missing data 2011) present detailed formulae for estimating SDs from P values, t or F values, CIs, ranges or other statistics. If these formulae did not apply, we calculated the SDs according to a validated 1. Overall loss of credibility imputation method, which was based on the SDs of the other At some degree of loss of follow-up, data must lose credibility included studies (Furukawa 2006). Although some of these im- (Xia 2009). We chose that, for any particular outcome, should putation strategies can introduce error, the alternative would have more than 50% of data have been unaccounted for, we would been to exclude a given study’s outcome and thus to lose informa- not reproduce these data or use them within analyses. If, however, tion. We nevertheless examined the validity of the imputations in more than 50% of those in one arm of a study were lost, but a sensitivity analysis excluding imputed values. the total loss was less than 50%, we addressed this within the ’Summary of findings’ table by down-rating quality. Finally, we also downgraded quality within the ’Summary of findings’ table 3.3 Last observation carried forward where loss was 25% to 50% in total. We anticipated that in some studies the method of last observation carried forward (LOCF) could be employed within the study re- 2. Binary port. As with all methods of imputation to deal with missing data, In the case where attrition for a binary outcome was between 0% LOCF introduces uncertainty about the reliability of the results and 50% and where these data were not clearly described, we (Leucht 2007). Therefore, had LOCF data been used in the trial, presented data on a ’once-randomised-always-analyse’ basis (an if less than 50% of the data had been assumed, we planned to intention-to-treat (ITT) analysis). Those leaving the study early present and use these data and indicate that they were the prod- were all assumed to have the same rates of negative outcome as uct of LOCF assumptions. However, we did not come across data those who completed, with the exception of the outcome of death from trials employing LOCF.

Psychoeducation (brief) for people with serious mental illness (Review) 12 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Assessment of heterogeneity in the methods section of the trial report were compared with actually reported results.

1. Clinical heterogeneity 2. Funnel plot We considered all included studies initially, without seeing comparison data, to judge clinical heterogeneity. We simply inspected These are again described in Section 10 of the Cochrane Handbook all studies for clearly outlying people or situations which we had for Systemic reviews of Interventions (Higgins 2011). We are aware not predicted would arise. When such situations or participant that funnel plots may be useful in investigating reporting biases but groups arose, these were fully discussed. are of limited power to detect small-study effects. We did not use funnel plots as no outcomes had more than 10 studies reporting data. 2. Methodological heterogeneity We considered all included studies initially, without seeing com- Data synthesis parison data, to judge methodological heterogeneity. We simply inspected all studies for clearly outlying methods which we had not We understand that there is no closed argument for preference for predicted would arise. When such methodological outliers arose, use of fixed-effect or random-effects models. The random-effects these were fully discussed. method incorporates an assumption that the different studies are estimating different, yet related, intervention effects. This often seems to be true to us and the random-effects model takes into 3. Statistical heterogeneity account differences between studies even if there is no statistically significant heterogeneity. There is, however, a disadvantage to the random-effects model. It puts added weight onto small studies, 3.1 Visual inspection which often are the most biased ones. Depending on the direction We visually inspected graphs to investigate the possibility of sta- of effect, these studies can either inflate or deflate the effect size. tistical heterogeneity. We chose the fixed-effect model for all analyses. The reader is, however, able to choose to inspect the data using the random- 3.2 Employing the I2 statistic effects model. Heterogeneity between studies was investigated by considering the I2 method alongside the Chi2 ’P’ value. The I2 provides an es- Subgroup analysis and investigation of heterogeneity timate of the percentage of inconsistency thought to be due to chance (Higgins 2003). The importance of the observed value of I 2 depends on i. magnitude and direction of effects and ii. strength 1. Subgroup analyses of evidence for heterogeneity (e.g. ’P’ value from Chi2 test, or a confidence interval for I2). An I2 estimate greater than or equal to around 50% accompanied by a statistically significant Chi2 1.1 Primary outcomes statistic, was interpreted as evidence of substantial levels of hetero- We planned to compare brief group psychoeducation and brief geneity (Section 9.5.2 - Higgins 2011). When substantial levels individual psychoeducation, for primary outcomes only. of heterogeneity were found in the primary outcome, we explored reasons for heterogeneity (Subgroup analysis and investigation of 1.2 Clinical state, stage or problem heterogeneity). We proposed to undertake this review and provide an overview of the effects of brief psychoeducation for people with schizophrenia Assessment of reporting biases in general. In addition, however, we reported data on subgroups of people in the same clinical state, stage and with similar problems.

1. Protocol versus full study Reporting biases arise when the dissemination of research findings 2. Investigation of heterogeneity is influenced by the nature and direction of results (Egger 1997). If inconsistency was high, this was reported. First, we investigated These are described in section 10.1 of the Cochrane Handbook for whether data had been entered correctly. Second, if data were Systemic reviews of Interventions (Higgins 2011). We tried to locate correct, we visually inspected the graph and outlying studies were the protocols of included randomised trials. If the protocol was successively removed to see if homogeneity was restored. For this available, outcomes in the protocol and in the published report review, we decided that should this occur with data contributing were compared. If the protocol was not available, outcomes listed to the summary finding of no more than around 10% of the total

Psychoeducation (brief) for people with serious mental illness (Review) 13 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. weighting, data would be presented. If not, data were not pooled or the precision of the effect estimates, then data from these trials and issues were discussed. We know of no supporting research for were included in the analysis. this 10% cut-off, but are investigating use of prediction intervals as an alternative to this unsatisfactory state. 4. Imputed values

When unanticipated clinical or methodological heterogeneity We had planned to undertake a sensitivity analysis to assess the were obvious, we simply stated hypotheses regarding these for fu- effects of including data from trials where we used imputed val- ture reviews or versions of this review. ues for ICC in calculating the design effect in cluster-randomised trials. If substantial differences had been noted in the direction or precision of effect estimates in any of the sensitivity analyses listed Sensitivity analysis above, we would not have pooled data from the excluded trials with the other trials contributing to the outcome, but presented them separately. However, no cluster-randomised trials were identified. 1. Implication of randomisation We aimed to include trials in a sensitivity analysis if they were described in some way as to imply randomisation. For the primary 5. Fixed and random effects outcomes, we included these studies and if there was no substantive All data were synthesised using a fixed-effect model, however, we difference when the implied randomised studies were added to also synthesised data for the primary outcome using a random- those with better description of randomisation, then all data were effects model to evaluate whether this altered the significance of employed from these studies. the results.

2. Assumptions for lost binary data Where assumptions were made regarding people lost to follow- RESULTS up (see Dealing with missing data), we compared the findings of the primary outcomes when we used our assumption/s and when we used data only from people who completed the study to that Description of studies point. If there was a substantial difference, we reported results and Please also see Characteristics of included studies and discussed them, but continued to employ our assumption. Characteristics of excluded studies. Throughout this review, study Where assumptions were made regarding missing SDs data (see ID’s have received a prefix before the principal author’s name and Dealing with missing data), we compared the findings of the pri- year of study (Xia 2011); the prefixes used include ’group’, ’in- mary outcomes when we used our assumption/s and when we used dividual’, ’both or ’unclear’, and each correspond to whether the data only from people who completed the study to that point. A brief psychoeducation intervention was received either as a group, sensitivity analysis was undertaken to test how prone results were individually, a mixture of both group and individual, or whether to change when completer-only data only were compared to the lack of information renders how the intervention was received imputed data using the above assumption. If there was a substan- as ’unclear’ (e.g. see Both - Liu 2004; Group - Aguglia 2007; tial difference, we reported results and discussed them, but con- Individual - Cunningham 2001; Unclear - Li 2005). tinued to employ our assumption.

Results of the search 3. Risk of bias The search of the Cochrane Schizophrenia Group Trials Regis- We analysed the effects of excluding trials that were judged to be ter, carried out in 2013, identified 268 references (see Figure 1), at high risk of bias across one or more of the domains of randomi- of which 20 studies were included (Characteristics of included sation (implied as randomised with no further details available), studies), 19 were excluded (Characteristics of excluded studies), allocation concealment, blinding and outcome reporting for the and 18 are awaiting classification (Characteristics of studies meta-analysis of the primary outcome. If the exclusion of trials at awaiting classification). Please refer to Figure 1 for the study screen- high risk of bias did not substantially alter the direction of effect ing process.

Psychoeducation (brief) for people with serious mental illness (Review) 15 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 5. Interventions Included studies Types of brief family intervention differed between studies and ranged from one-day delivery (Group - Razali 1995) to sessions delivered over a period 12 months (Group - Aguglia 2007). We 1. Setting compared our defined brief family intervention (10 sessions or less) to standard/ routine care or information (as defined in each study), Ten of the 20 included studies were conducted in China, three which included interventions such as cognitive behavioural ther- studies were conducted in Germany, two in the UK, with the one apy (CBT, as in Group - Bechdolf 2004), medication treatment each of the remaining studies conducted in either Italy, Malaysia, alone (as specified in Group - Aguglia 2007; Group - Coyle 1988) Pakistan, Denmark or Jamaica. Of the studies that described par- or other routine forms of health education (Both - Zhang 2004) ticipant status, three studies included outpatients, and two con- or rehabilitation (Both - Liu 2004). The remaining majority of the ducted with hospital inpatients (one of which was an acute in- included studies used either the terms ’standard care’, ’routine care’ patient setting, Group - Bechdolf 2004). Three of the included or simply ’no form of brief psychoeducation’ (however defined). studies were multi-centre (Group - Aguglia 2007; Group - Bauml 2007; Individual - Cunningham 2001). 6. Outcome scales A variety of scales were used to assess clinical response and adverse 2. Length of studies events. We were, however, unable to use some of the scale-derived data due to poor reporting. Details of scales that provided usable Length of studies ranged from one day/one session (Group - Razali data are shown below. 1995) to eight sessions delivered over a period of 12 months ( Group - Aguglia 2007). The mean length of study was calculated at 13 weeks. Follow-up periods ranged from six months (Group - 6.1 Compliance Bechdolf 2004) to five years (Group - Hornung 1995). 6.1.1 Schedule for Assessment of Insight - SAI (David 1990) The SAI rates three dimensions of insight: treatment adherence, recognition of illness and symptom re-labelling. These three sub- 3. Participants scales provide a summed total of insight score. High score indicates In total, there were 2337 participants included in this review; only better insight. One study reported skewed data from this scale. 50% of studies reported individual male and female numbers in 6.1.2 Compliance scale ( Kemp 1998) study populations, with 612 known males and 473 known females The compliance scale is a four-point rating scale used by Kemp included in, at least, 10 of the included studies. All participants 1998, starting from 1 up to 4. A higher score represents better had a diagnosis of schizophrenia or schizoaffective disorder; the compliance: 1, complete or partial refusal (refused depot or accepts most frequently used diagnostic criteria were Diagnostic and Sta- only minimum dose); 2, takes medication irregularly (interrup- tistical Manual of Mental Disorders (DSM-III or DSM-IV) (in tion of medication < four weeks), reluctant, requires persuasion, nine of the included studies), Chinese Classification of Mental disagrees with psychiatrist in charge about dose; 3, takes medica- Disorders (CCMD-2 or CCMD-3) (in six of the included stud- tion regularly (interruption of medication < one week), agrees with ies), International Classification of Diseases (ICD-9/10) (in one psychiatrist-in-charge about dose; 4, active participation, readily of the included studies) and F20.2/ F20.9 (in one of the included accepts and shows some responsibility for regimen. studies conducted in Denmark). The remaining three studies did not specify diagnostic criteria, but stated that participants had 6.2 Mental state ’schizophrenia’. One of the included studies included acute patients (Group - Bechdolf 2004) 6.2.1 Brief Psychiatric Rating Scale - BPRS (Overall 1962) The BPRS is an 18-item scale measuring positive symptoms, general psychopathology and affective symptoms. The original scale has 16 items, but a revised 18-item scale is commonly used. Scores 4. Trial size can range from 0 to 126. Each item is rated on a seven-point scale Trial sizes ranged from n = 30 (Both - Tom 1989) to n = 286 par- varying from ’not present’ to ’extremely severe’, with high scores ticipants (Unclear - Li 2005), with the mean sample size calculated indicating more severe symptoms. Four studies reported data from at n = 117. this scale.

Psychoeducation (brief) for people with serious mental illness (Review) 16 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 6.2.2 General Well-being Schedule - GWB (Taylor 2003) 6.5 Knowledge This is an 18-item, reliable measurement scale for psychological 6.5.1 Insight Treatment Attitude Questionnaire - ITAQ (McEvoy well-being. High scores indicate better outcome. One study re- 1989) ported data from this scale. The ITAQ is a 11-item semi-structured interview that measures 6.2.3 Positive and Negative Syndrome Scale - PANSS (Kay 1986) awareness of illness and attitude to medication and services, as well This is a 30-item scale, each of which can be defined on a seven- as follow-up evaluation. Its scores range from 0 to 22, with high point scoring system from absent to extreme. It has three sub-scales scores indicating better insight. Two studies reported data from for measuring the severity of general psychopathology, positive this scale. symptoms (PANSS-P), and negative symptoms (PANSS-N). A 6.5.2 The Scale to Assess Unawareness of Mental Disorder - low score indicates lesser severity. One study reported data from SAUMD (Amador 1994) this scale. There is a total of 20 questions in SAUMD. Score range one to five 6.2.4 Rosenberg Self-esteem Scale - SES (Rosenberg 1965) points, a high score prompts a poor understanding and attribution. The scale is a 10-item Likert scale with items answered on a four- One study reported data from this scale. point scale - from strongly agree to strongly disagree. High scores 6.5.3 Understanding of medication questionnaire - UMQ ( indicate better outcome. One study reported data from this scale. Macpherson 1996) 6.2.5 Montgomery-Åsberg Depression Rating Scale - MADRS UMQ measures knowledge of antipsychotic treatment. Fourteen (Montgomery 1979) stem questions generate eight sub-scale knowledge scores, relating This is a 10-item, psychiatrist-administered scale to rate severity of to factual information, treatment practice, treatment rationale, ef- depressive episodes in people with mood disorders. Overall scores fects of stopping treatment, side effects, precautions, tardive dyski- range from 0 to 54 points, with a higher score indicating a worse nesia and risk/benefit evaluation.The UMQ is an extended version outcome. One study reported skewed data using this scale. of scales measuring knowledge of illness and treatment and knowl- 6.2.6 Zung Self-Rating Anxiety Scale - SAS (Ramirez 2008) edge of tardive dyskinesia. Total knowledge score is 35. Knowledge This scale is self-administered and has 20 questions. Each question scoring 0 = no understanding and 35 = full understanding. One is scored on a scale of one to four. High score indicates poor study reported data from this scale. One study reported skewed outcome. One study reported data from this scale. data from this scale. 6.2.7 Zung Self-Rating Depression Scale - SDS (Gregory 1994) 6.5.4 Knowlege About Schizophrenia Questionnaire-KSQ( High scores indicate a poor outcome. One study reported data Falloon 1983) from this scale. KSQ is used to measure knowledge of mental illness and treatment, comprising of two parts.The first part consists of six open- 6.3 Social functioning ended questions and the second part contains 14 multiple-choice questions.The scores range from 0 to 44. A higher score prompts 6.3.1 Morningside Rehabilitation Status Scale - MRSS ( a better understanding of schizophrenia-related knowledge.One McCreadie 1987) study reported data from this scale. High scores indicates a worse outcome. One study reported data from this scale. 6.3.2 Social Disability Screening Schedule - SDSS (Tu 1997) 6.6 Global state High scores indicate a poor outcome. One study reported data 6.6.1 Global Assessment of Functioning - GAF (APA 1994) from this scale. The scale is a 90-point rating scale that assesses psychological, social and occupational functioning. GAF is included in DSMIII- R 6.4 Quality of life as axis V, but in spite of this there is little research on the reliability 6.4.1 Family Assessment Device - FAD (Epstein 1983) and validity of the instrument. A few reliability and validity as- High scores indicate unhealthy family functioning. One study sessments have been made, indicating that an acceptable interrater reported data from this scale. reliability can be attained and that modest validity in relation to a 6.4.2 Family Burden Interview Schedule - FBIS (Pai 1981) disability measure has been demonstrated. High scores indicate a High scores indicate a worse outcome. One study reported data better outcome. One study reported data from this scale. from this scale. 6.6.2 Global Assessment Scale - GAS (Endicott 1976) 6.4.3 General Quality of Life Inventory -74 - GQOLI-74 (Wang GAS is a 0-100 point rating scale, a global measure of overall func- 1999) tioning and symptomatology. High scores indicate better func- A 74-item quality of life assessment scale. It contains four sub- tioning. One study reported data from this scale. scales that assess physical functioning, psychological functioning, social functioning, and standard of living. High scores indicate 6.7 Expressed emotion better quality of life. One study reported data from this scale.

Psychoeducation (brief) for people with serious mental illness (Review) 17 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 6.7.1 Family Questionnaire - FQ (Feinstein 1989) 6.9 Missing outcomes The FQ is based on the Camberwell Family Interview and is a Most studies reported outcomes of interest as specified in our pro- 20-item questionnaire developed to enable a less time-consum- tocol; however, some relevant outcomes of significance were either ing evaluation of expressed emotion in relatives. It covers the two not measured or not reported, including global state outcomes, dimensions of criticism and emotional over-involvement and the specific or general adverse events or effects, and changes in be- items are scored on a four-point scale. The questionnaire is re- haviour. Economic outcomes, which would be of particular inter- liability tested and validated in the German language (Feinstein est regarding the nature of the intervention, were either not re- 1994 personal communication). One study reported skewed data ported or not measured in the studies and references we obtained. using this scale. One study reported data using this scale.

Excluded studies 6.8 Satisfaction with care In total, 19 studies were excluded with reasons, including non-randomised studies, irrelevant interventions, or no identifiable usable 6.8.1 Verona Service Satisfaction Scale - VSSS (Ruggeri 1993) data. These studies are best inspected by viewing Characteristics The scale consists of 54 items in versions for patients and rela- of excluded studies. tives. It is a questionnaire that covers seven dimensions of satisfaction with service: overall satisfaction, professionals’ skills and behaviour, information, access, efficacy, types of intervention and Awaiting assessment relatives’ involvement. (Ruggeri 1996) The VSSS satisfaction rat- Eighteen studies are await assessment - descriptions of these studies ings are given on a five-point Likert scale. The instrument has can be found in Characteristics of studies awaiting classification. been validated in community psychiatric samples (Ruggeri 1994; Ruggeri 1996). One study reported data from this scale. 6.8.2 Client Satisfaction Questionnaire-8 - CSQ-8 (Nguyen Ongoing Studies 1983) There are currently no ongoing studies that we are aware of. The CSQ-8 consists of eight items selected from the preliminary CSQ scale (Larsen 1979), which comprises 31 items in total.The Risk of bias in included studies eight questions could obtain a minimum score of eight to a maximum score of 32. A higher score will indicate a higher level of See Figure 2 and Figure 3 as well as Characteristics of included satisfaction. One study reported data from this scale. studies for details as to each study’s ’Risk of bias’ assessment.

Figure 2. ’Risk of bias’ graph: review authors’ judgements about each risk of bias item presented as percentages across all included studies.

Psychoeducation (brief) for people with serious mental illness (Review) 18 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Figure 3. ’Risk of bias’ summary: review authors’ judgements about each risk of bias item for each included study.

Psychoeducation (brief) for people with serious mental illness (Review) 19 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Allocation continuous data from rating scales) (Both - Tom 1989; Group Overall, the majority of included studies were rated as a ’low’ risk of - Chan 2009; Group - Dai 2007) and inconsistency in reported bias regarding random sequence generation, with 55% providing participant numbers between multiple publications of the same adequate detail regarding randomisation procedures. Methods of study (Group - Bechdolf 2004). randomisation included computer-generated programmes (Group - Bechdolf 2004), central and independent randomisation at each study site in a multi-centre study (Group - Bauml 2007), drawing Other potential sources of bias lots (Group - Chan 2009), as well as stratiﬁed random sampling The majority of included studies were rated as a ’low’ risk of bias (Group - Coyle 1988). The remaining 45% of studies were rated on this domain (60%); only one study was rated as a ’high’ risk as ’unclear’ where the word ’randomised’ was stated but no further (Group - Razali 1995), as participants in the control group re- details were provided. ceived an unequal amount of therapist time than the intervention Allocation concealment was generally rated as an ’unclear’ risk group. Only two studies provided details as to sources of fund- among the majority of the studies (75%), with the remaining pro- ing, which was generally medical research council-funded, one in viding description as to allocation concealment procedures per- Germany (Group - Bauml 2007) and one in the UK (Individual mitting a rating of ’low’ risk of bias (25%). - Cunningham 2001).

Blinding Effects of interventions Blinding of participants and outcome measures were largely rated See: Summary of findings for the main comparison ANY as an ’unclear’ risk of bias across the two domains - only one FORM OF BRIEF PSYCHOEDUCATION compared with for included study mentioned blinding procedures (Group - Merinder ROUTINE CARE/INFORMATION; Summary of findings 2 1999), which specified that outcomes were assessor-blinded. Due ANY FORM OF BRIEF PSYCHOEDUCATION compared to the nature of the intervention, we were not anticipating studies with CBT for people with serious mental illness to be double blind; however, there was lack of information as to We calculated risk ratios (RR) for dichotomous data and estimated whether raters were blinded as to allocation of intervention for mean differences (MD) for continuous data, with their respective purposes of rating outcomes such as compliance, relapse and other 95% confidence intervals (CIs). continuous measures.

Incomplete outcome data COMPARISON 1: ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE Generally, outcome-reporting was consistent and well-reported in CARE/INFORMATION 50% of the included studies rated as a ’low’ risk of bias, with 15% rated as an ’unclear’ risk where numbers leaving the study early were not made clear or no mention was made in the study report. The remaining 35% were rated as a ’high’ risk of bias on this 1.1 Compliance: 1a. With medication - non-compliance domain, which included where a study did not state reasons for participants leaving the study early (Group - Aguglia 2007; Group - Bauml 2007), where participants leaving the study early were not 1.1.1 short term considered (Group - Hornung 1995), or where such participants In this subgroup we found three relevant trials (n = 448). There were expressly excluded from analysis (Group - Li 2003). was a statistically significant difference favouring any form of psychoeducation over routine care/information (RR 0.63 CI 0.41 to Selective reporting 0.96). The majority of studies were rated as a ’low’ risk of bias on this domain (60%), with outcomes generally well-reported. Those rated 1.1.2 medium term at an unclear risk (20%) included for reasons such as lack of thorough reporting of continuous outcome measures, i.e. no standard In this subgroup we only found one relevant trial (n = 118) (Both - deviations (Group - Aguglia 2007; Group - Coyle 1988). The re- Liu 2004). There was a statistically significant difference favouring maining 20% were rated as a ’high’ risk of bias for reasons includ- any form of psychoeducation over routine care/information (RR ing no presentation of pre-specified outcome measures (largely 0.17 CI 0.05 to 0.54).

Psychoeducation (brief) for people with serious mental illness (Review) 20 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1.2 Compliance: 1b. With medication - partial compliance 1.5.2 short term - received intervention but left the study (medium term) early In this subgroup we only found one relevant trial (n = 118) (Both In this subgroup we only found one relevant trial (n = 67) - Liu 2004). There was no signiﬁcant difference between any form (Individual - Macpherson 1996). There was no signiﬁcant differ- of psychoeducation and routine care/information (RR 0.68, CI ence between any form of psychoeducation and routine care/in- 0.39 to 1.18, Analysis 1.2). formation (RR 3.06, CI 0.17 to 56.70).

1.5.3 medium term - loss to follow-up for any reason 1.3 Compliance: 1c.With medication - continuous outcomes (numeric compliance scale, data skewed) In this subgroup we found four relevant trials (n = 322). With assumption data, there was no signiﬁcant difference between any Data for this outcome from one study were skewed, and are best form of psychoeducation and routine care/information (RR 0.74 inspected by viewing Analysis 1.3. CI 0.50 to 1.09).

1.4 Compliance: 1d. With medication - very good/good 1.5.4 long term - loss to follow-up for any reason (by one compliance year) In this subgroup we only found two relevant trials (n = 386) (Group - Aguglia 2007; Group - Bauml 2007). There was no significant difference between any form of psychoeducation and routine care/ 1.4.1 Medium term information (RR 1.19, CI 0.83 to 1.72) In this subgroup we only found one relevant trial (n = 236) (Group - Bauml 2007). There was no statistically significant difference between psychoeducation and routine care/information group. (RR 1.5.5 long term - loss to follow-up for any reason (by two 1.05 CI 0.93 to 1.18). years) In this subgroup we only found two relevant trials (n = 387) (Group - Bauml 2007; Group - Hornung 1995). There was no significant 1.4.2 Long term by one year difference between any form of psychoeducation and routine care/ In this subgroup we only found one relevant trial (n = 236) (Group information (RR 0.83, CI 0.62 to 1.11). - Bauml 2007). There was a statistically significant difference favouring any form of psychoeducation over routine care/infor- 1.5.6 long term - loss to follow-up for any reason (by five mation (RR 1.39 CI 1.16 to 1.66). years or more) In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between 1.4.3 Long term by two years any form of psychoeducation and routine care/information (RR In this subgroup we only found one relevant trial (n = 236) (Group 0.73, CI 0.44 to 1.21). - Bauml 2007). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (RR 1.46 CI 1.20 to 1.76). 1.5.7 long term- received intervention but left the study early In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was a statistically significant (P = 0.05) 1.5 Compliance: 2a. With follow-up - loss to follow-up for difference favouring any form of psychoeducation over routine any reason care/information (RR 0.58 CI 0.33 to 1.01).

1.6 Relapse: 1. Relapse for any reason 1.5.1 short term - loss to follow-up for any reason In this subgroup we only found one relevant trial (n = 30) (Both - Tom 1989). There was no signiﬁcant difference between any form 1.6.1 medium term of psychoeducation and routine care/information (RR 1.00, CI In this subgroup we found four relevant trials (n = 406). There 0.24 to 4.18) was a statistically signiﬁcant difference (P = 0.01) favouring any

Psychoeducation (brief) for people with serious mental illness (Review) 21 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. form of psychoeducation over routine care/information (RR 0.70 1.10 Knowledge: 1c. Average endpoint (ITAQ, high = good, CI 0.52 to 0.93). data skewed) Data for this outcome from one study were skewed, and are best inspected by viewing Analysis 1.10. 1.6.2 long term

In this subgroup we only found one relevant trial (n = 124) (Group 1.11 Knowledge: 2. Average endpoint scores(SAUMD, high = - Hornung 1995). There was no significant difference between poor) (short term ) any form of psychoeducation and routine care/information (RR 0.85, CI 0.59 to 1.22) In this subgroup we only found one relevant trial (n = 81) (Group - Chan 2007). There was no statistically significant difference between any form of psychoeducation and routine care/information (MD -1.18, CI -2.46 to 0.10, Analysis 1.11) 1.6.3 long term (at five years follow-up) In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between 1.12 Global state: 2. Average endpoint scale score any form of psychoeducation and routine care/information (RR 0.89, CI 0.73 to 1.08) 1.12.1 short term - (GAF/GAS, high = good) In this subgroup we only found one relevant trial (n = 41) (Group 1.7 Relapse: 2. Relapse with readmission - Merinder 1999). There was no significant difference between any form of psychoeducation and routine care/information (MD In this subgroup we only found one relevant trial (n = 124) (Group -2.64, CI -12.74 to 7.46) - Hornung 1995). There was no significant difference between any form of psychoeducation and routine care/information in the medium term (RR 0.85, CI 0.59 to 1.22) and long term (RR 0.83, 1.12.2 medium term - (GAF/GAS, high = good) CI 0.64 to 1.08) Analysis 1.7. In this subgroup we found two relevant trials (n = 101) (Group - Hornung 1995; Group - Merinder 1999). There was no significant difference between any form of psychoeducation and routine care/ 1.8 Knowledge: 1a. Average endpoint scale scores on various information (MD -0.50, CI -5.48 to 4.47). This subgroup had knowledge scales important levels of heterogeneity (Chi2 = 2.4; df = 1; P = 0.122; I2 = 58%).

1.8.1 short term (ITAQ, high = favourable) 1.12.3 long term - (GAS, high = good) - at two years In this subgroup we found two relevant trials (n = 97) (Group - In this subgroup we only found one relevant trial (n = 59) (Group Chan 2009; Both - Tom 1989). There was a statistically signiﬁcant - Hornung 1995). There was a statistically signiﬁcant difference difference (P < 0.00001) favouring any form of psychoeducation favouring routine care/information over any form of psychoedu- over routine care/information (MD 7.39 CI 4.94 to 9.83). cation (MD -6.70 CI -13.38 to -0.02).

1.8.2 medium term (ITAQ, high = favourable) 1.12.4 long term - (GAS, high = good) - at five years or more In this subgroup we only found one relevant trial (n = 73) (Group - In this subgroup we only found one relevant trial (n = 60) (Group - Hornung 1995). There was no statistically significant difference Chan 2009). There was a statistically significant difference favour- between any form of psychoeducation and routine care/informa- ing any form of psychoeducation over routine care/information tion (MD -3.80, CI -8.04 to 0.44). (MD 4.83 CI 1.51 to 8.15).

1.13 Service utilisation: rehospitalisation 1.9 Knowledge: 1b. Average change (UMQ, high = good, data We found two relevant trials (n = 188). There was no signiﬁcant skewed) difference between any form of psychoeducation and routine care/ Data for this outcome from one study were skewed, and are best information in the medium term (RR 0.88 CI 0.43 to 1.79) and inspected by viewing Analysis 1.9. long term (one trial, n = 141, RR 0.05 CI 0.51 to 1.00).

Psychoeducation (brief) for people with serious mental illness (Review) 22 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1.14 Mental state: 1a. Global - continuous - average total 1.18.2 depression - SDS endpoint scale scores (BPRS, high = poor) In this subgroup we only found one relevant trial (n = 146) (Both - Zhang 2004). There was a statistically significant difference favouring any form of psychoeducation over routine care/infor- 1.14.1 short term mation (MD -7.62 CI -10.91 to -4.33). In this subgroup we only found one relevant trial (n = 60) (Group - Zhang 2006). There was a statistically significant difference favouring any form of psychoeducation over routine care/infor- 1.19 Mental state: 2b. Specific - continuous - average mation (MD -2.70 CI -4.84 to -0.56). endpoint scores (MADRS, high = poor, data skewed) Data for this outcome from one study were skewed, and are best 1.14.2 medium term inspected by viewing Analysis 1.19. In this subgroup we only found one relevant trial (n = 120) (Group - Li 2003). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (MD 1.20 Social functioning: 1a. Average change scores on -5.36 CI -6.77 to -3.95). various scales - medium term (high = poor)

1.15 Mental state: 1b. Global - continuous - average change scale scores (GWB/SES, high = good) (medium term) 1.20.1 rehabilitation status - MRSS We only found one relevant trial (n = 118) (Both - Liu 2004). In this subgroup we only found one relevant trial (n = 118) (Both - There was a statistically signiﬁcant difference favouring any form Liu 2004). There was a statistically signiﬁcant difference favouring of psychoeducation over routine care/information for both general routine care/information over any form of psychoeducation (MD well-being (MD 10.89 CI 9.82 to 11.96) and self-esteem(MD -13.68 CI -14.85 to -12.51). 8.00 CI 7.77 to 8.23) Analysis 1.15.

1.16 Mental state: 1c. Global - continuous - average total 1.20.2 social disability - SDSS endpoint scale scores (BPRS, high = poor, data skewed) In this subgroup we only found one relevant trial (n = 118) (Both - Data for this outcome from two studies were skewed, and are best Liu 2004). There was a statistically signiﬁcant difference favouring inspected by viewing Analysis 1.16. routine care/information over any form of psychoeducation (MD -1.96 CI -2.09 to -1.83).

1.17 Mental state: 2a. Specific symptoms - binary - specific symptoms - short term 1.21 Expressed emotion (EE): Participants with high EE We only found one relevant trial (n = 146) (Both - Zhang 2004). relatives (FQ) There was a statistically significant difference favouring any form of psychoeducation over routine care/information for anxiety (RR 0.49 CI 0.25 to 0.93) and depression (RR 0.47 CI 0.25 to 0.88) Analysis 1.17 1.21.1 short term - at end of interventions In this subgroup we only found one relevant trial (n = 46) (Group - Merinder 1999). There was no significant difference between any 1.18 Mental state: 2a. Specific symptoms - specific form of psychoeducation and routine care/information(RR 0.65, symptoms - short term CI 0.37 to 1.16)

1.18.1 anxiety - SAS 1.21.2 medium term In this subgroup we only found one relevant trial (n = 146) (Both - Zhang 2004). There was a statistically signiﬁcant difference Data from the same trial found no signiﬁcant difference between favouring any form of psychoeducation over routine care/infor- any form of psychoeducation and routine care/information (n = mation (MD -6.11 CI -9.24 to -2.98). 46, RR 1.07, CI 0.64 to 1.78).

Psychoeducation (brief) for people with serious mental illness (Review) 23 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1.22 Expressed emotion for relatives: Average Change 1.27 Satisfaction with mental health services: 2. Average scores on FQ scales (high = good) (short term - at end of change - at one year (VSS Scale, high = good) interventions) Only one trial reported the change of expressed emotion for relatives of schizophrenia patients. Result showed that there is no 1.27.1 patients’ satisfaction with relatives’ involvement - significant difference between any form of psychoeducation and mean change routine care (n = 29, MD -3.25, CI -8.24 to 1.74, Analysis 1.22). In this subgroup we only found one relevant trial (n = 30) (Group - Merinder 1999). There was a statistically significant difference favouring routine care/information over any form of psychoedu- 1.23 Quality of life: 1a. Average endpoint scores (GQOLI-74, cation (MD -4.35 CI -7.09 to -1.61). high = favourable) In this subgroup we only found one relevant trial (n = 62) (Group - Lv 2007). There was no significant difference between any form of 1.27.2 relatives’ involvement satisfaction psychoeducation and routine care/information in the short term In the same trial (n = 21) (Group - Merinder 1999), there was no (MD 0.63, CI -0.79 to 2.05), but a statistically significant dif- significant difference between any form of psychoeducation and ference favouring any form of psychoeducation over routine care/ routine care/information .(MD -2.17, CI -6.11 to 1.77) information in the medium term (MD 2.13 CI 1.03 to 3.23). Analysis 1.23 1.27.3 relatives’ efficacy satisfaction In the same trial (n = 24) (Group - Merinder 1999), there was no 1.24 Quality of life: 1b. Average endpoint scores (FAD, high = significant difference between any form of psychoeducation and poor) routine care/information (MD -2.16, CI -7.29 to 2.97). In this subgroup we only found one relevant trial (n = 62) (Group - Lv 2007). There was no significant difference between any form of psychoeducation and routine care/information in the short term 1.27.4 relatives’ intervention satisfaction (MD -0.42, CI -5.45 to 4.61), but a statistically significant dif- In the same trial (n = 26) (Group - Merinder 1999), there was no ference was found favouring any form of psychoeducation over significant difference between any form of psychoeducation and routine care/information (MD -6.79 CI -11.67 to -1.91). Analysis routine care/information .(MD -3.43, CI -9.83 to 2.97) 1.24

1.28 Patients’ satisfaction with mental health services: 1.25 Quality of life: 1c. Average endpoint scores (FBIS, high average endpoint scores - short term (CSQ, high = good) = poor, data skewed) In this subgroup we only found one relevant trial (n = 24) (Both - Data for this outcome from one study were skewed, and are best Tom 1989). There was no signiﬁcant difference between any form inspected by viewing Analysis 1.25 . of psychoeducation and routine care/information Analysis 1.28.

1.26 Satisfaction with mental health services: 1.Average change score - short term (VSS Scale/CSQ, high = good) 1.29 Adverse event: Death

1.26.1 patients’ satisfaction 1.29.1 medium term In this subgroup we only found one relevant trial (n = 32) (Group In this subgroup we found two relevant trials (n = 154) (Group - - Merinder 1999 ). There was no signiﬁcant difference between Merinder 1999; Individual - Nasr 2009). There was no signiﬁcant any form of psychoeducation and routine care/information (MD difference between any form of psychoeducation and routine care/ -2.15, CI -13.96 to 9.66) information (RR 0.99, CI 0.15 to 6.65) .

1.26.2 relatives’ satisfaction 1.29.2 long term In this subgroup we only found one relevant trial (n = 17) (Group In this subgroup we only found one relevant trial (n = 124) (Group - Merinder 1999). Again, there was no signiﬁcant difference be- - Hornung 1995). There was no signiﬁcant difference between tween any form of psychoeducation and routine care/information any form of psychoeducation and routine care/information (RR (MD -10.81, CI -32.22 to 10.60). 0.85, CI 0.05 to 13.30).

Psychoeducation (brief) for people with serious mental illness (Review) 24 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Comparison 2: ANY FORM OF BRIFE 3.1.1 group - short term PSYCHOEDUCATION versus Cognitive Behavourial In this subgroup we found two relevant trials (n = 162). There was Therapy (CBT) no statistically signiﬁcant difference between group psychoeducation and routine care/information (Analysis 3.1).

2.1 Compliance: 1b. With medication (numeric compliance scale, high = good) 3.1.2 unclear - short term In this subgroup we only found one relevant trial (Group - We identified one relevant trial in this subgroup (n = 286, Unclear Bechdolf 2004). There was no statistically significant difference - Li 2005). There was no statistically significant difference between between any form of psychoeducation and routine care/informa- either group psychoeducation or individual psychoeducation (un- tion at either short term (n = 88, MD -0.20, CI -0.42 to 0.02), clear) and routine care/information (Analysis 3.1). medium term (n = 88, MD -0.30, CI -0.70 to 0.10), nor long term (n = 41, (MD -0.50, CI -1.05 to 0.05, Analysis 2.1). 3.1.3 both - medium term 2.2 Relapse: Relapse for any reason (medium term) In this subgroup we only found one relevant trial (n = 118) (Both - There is no statistical difference between brief psychoeducation Liu 2004). There was a statistically significant difference favouring and CBT for this outcome in the medium term (n = 88, RR1.67, psychoeducation delivered either via group or individually (’both’) CI 0.62 to 4.48, Analysis 2.2), however this no difference may due over routine care/information (RR 0.17 CI 0.05 to 0.54, Analysis to the wide confidence interval resulting from the small sample 3.1). size.

3.2 Compliance: 1b. With follow up - loss to follow-up for any 2.3 Service utilisation: hospitalisation (long term) reason There is no statistical difference between brief psychoeducation and CBT for this outcome in the long term (n = 43, RR1.58, CI 0.78 to 3.20, Analysis 2.3). In the same case with relapse, this no 3.2.1 both - short term - loss to follow-up for any reason difference may due to the wide confidence interval. In this subgroup we only found one relevant trial (n = 30) (Both - Tom 1989). There was no significant difference between group 2.4 Mental state: Specific - continuous - average endpoint psychoeducation and routine care/information (Analysis 3.2). PANSS scores (high = poor) We only found one relevant trial (n = 88) (Group - Bechdolf 2004). There was no significant difference between any form of psychoe- 3.2.2 group - medium term - loss to follow-up for any reason ducation and routine care/information in the short or medium In this subgroup we found three relevant trials (n = 208). There term, nor in the long term (n = 41). Analysis 2.4 was no significant difference between group psychoeducation and routine care/information (Analysis 3.2).

2.5 Quality of life - Average endpoint MSQoL-54 score

In this subgroup we only found one relevant trial (n = 63) (Group 3.2.3 individual - medium term - loss to follow-up for any - Bechdolf 2004). There was no significant difference between reason any form of psychoeducation and routine care/information in the In this subgroup we only found one relevant trial (n = 114) short term (MD 1.80, CI -10.17 to 13.77) or medium term (n = (Individual - Cunningham 2001). There was no significant differ- 64, MD 4.50, CI -6.66 to 15.66). Analysis 2.5 ence between individual psychoeducation and routine care/information (Analysis 3.2). SUBGROUP ANALYSES 3. GROUP PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION versus ROUTINE 3.2.4 group - long term - loss to follow-up for any reason (by CARE/INFORMATION one year) In this subgroup we found two relevant trial (n = 386) (Group - Aguglia 2007). There was no significant difference between group 3.1 Compliance: 1a. With medication - non-compliance psychoeducation and routine care/information (Analysis 3.2).

Psychoeducation (brief) for people with serious mental illness (Review) 25 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 3.2.5 group - long term - loss to follow-up for any reason (by 4.1.1 Compliance: With medication - non-compliance two years) After excluding studies with high risk of bias assessment, no data In this subgroup we only found one relevant trial (n = 124) (Group are left to compare in this outcome (Both - Liu 2004; Group - Dai - Hornung 1995). There was no significant difference between 2007; Group - Zhang 2006; Unclear - Li 2005). group psychoeducation and routine care/information (Analysis 3.2). 4.1.2 Compliance: With follow up - loss to follow-up for any reason 3.2.6 group - long term - loss to follow-up for any reason (by There is no difference in the estimate of the effect in data analyses five years or more) when the one study that implied randomisation was removed from In this subgroup we only found one relevant trial (n = 124) (Group synthesis (Group - Aguglia 2007). - Hornung 1995). There was no significant difference between group psychoeducation and routine care/information (Analysis 3.2). 4.1.3 Relapse: Relapse for any reason After removing the two studies that merely implied randomisation from data synthesis (Group - Chan 2007; Group - Razali 1995), 3.3 Relapse: 1. Relapse for any reason there is no significantly difference in the estimate of effect.

3.3.1 group - medium term 4.2 Assumptions for lost binary data In this subgroup we found 3 relevant trials (n = 292). There was no statistically signiﬁcant difference between group psychoeducation 4.2.1 Compliance: With medication - non-compliance and routine care/information. (RR 0.72 CI 0.51 to 1.02, Analysis 3.3). There was no difference in the estimate of the effect when our assumptions were replaced with completer-only data.

3.3.2 individual - medium term 4.2.2 Compliance: With follow-up - loss to follow-up for any We found one relevant trial in this subgroup (n = 114, Individual reason - Cunningham 2001). There was no signiﬁcant difference between individual psychoeducation and routine care/information There was no difference in the estimate of the effect when our (Analysis 3.3). assumptions were replaced with completer-only data.

4.2.3 Relapse: Relapse for any reason 3.3.3 group - long term There is no missing data for the primary outcomes in compari- In this subgroup we only found one relevant trial (n = 124, Group son 1; For comparison 2, there is no difference between brief psy- - Hornung 1995). There was no signiﬁcant difference between choeducation and CBT for relapse after removing the assumptions group psychoeducation and routine care/information (Analysis (Group - Bechdolf 2004, Analysis 4.1) 3.3).

4.3 Risk of bias 3.3.4 group - long term (at five years follow-up) In this subgroup we only found one relevant trial (n = 124, Group - Hornung 1995). There was no significant difference between 4.3.1 Compliance: With medication - non-compliance group psychoeducation and routine care/information (Analysis After removing the two studies that were rated as a ’high’ risk of 3.3) bias across one or more of the risk of bias domains from data synthesis (Group - Dai 2007; Unclear - Li 2005), results were no 4. SENSITIVITY ANALYSIS longer significantly in favour of brief psychoeducation in the short term, and instead demonstrating no difference between groups (n = 60, RR 0.67, CI 0.12 to 3.71) Analysis 5.1. However, this non- significance is more likely due to the small sample size resulting in 4.1 Implication of randomisation a wider confidence interval.

Psychoeducation (brief) for people with serious mental illness (Review) 26 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 4.3.2 Compliance: With follow-up - loss to follow-up for any 4.5 Fixed and random effects reason There was no difference in the estimate of the effect when studies that were rated as a ’high’ risk of bias across one or more of the 4.5.1 Compliance: With medication - non-compliance risk of bias domains were removed from synthesis. There was no difference in the estimate of the effect when a random-effects model was used for data synthesis instead of a ﬁxed- effect model. 4.3.3 Relapse: Relapse for any reason After removing the two studies that were rated as a ’high’ risk of 4.5.2 Compliance: With follow-up - loss to follow-up for any bias across one or more of the risk of bias domains from data reason synthesis (Group - Bechdolf 2004; Group - Razali 1995), there There was no difference in the estimate of the effect when a ran- was no difference in the estimate of the effect. dom-effects model was used for data synthesis instead of a ﬁxed- effect model.

4.4 Imputed values We had planned to undertake a sensitivity analysis to assess the 4.5.3 Relapse: Relapse for any reason effects of including data from trials where we used imputed val- There was no difference in the estimate of the effect when a ran- ues for ICC in calculating the design effect in cluster-randomised dom-effects model was used for data synthesis instead of a ﬁxed- trials. however, no cluster-randomised trials were identiﬁed. effect model.

Psychoeducation (brief) for people with serious mental illness (Review) 27 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. oyih 05TeCcrn olbrto.Pbihdb J by Published Collaboration. Cochrane The ill 2015 mental © serious Copyright with people for (brief) Psychoeducation ADDITIONALSUMMARYOFFINDINGS [Explanation]

ANY FORM OF BRIEF PSYCHOEDUCATION compared with CBT for people with serious mental illness

Patient or population: patients with people with serious mental illness Settings: Intervention: ANY FORM OF BRIEF PSYCHOEDUCATION Comparison: CBT

Outcomes Illustrative comparative risks* (95% CI) Relative effect No of Participants Quality of the evidence Comments (95% CI) (studies) (GRADE)

Assumed risk Corresponding risk

es(Review) ness CBT ANY FORM OF BRIEF

h ie os Ltd. Sons, & Wiley ohn PSYCHOEDUCATION

Compliance: With med- The mean compliance: The mean compliance: 88 ⊕ ication (numeric com- with medication in the with medication (numeric (1 study) very low1,2,3 pliance scale, high = control groups was compliance scale, high = good) - short term 3.9 points. good) - short term in the Follow-up: up to 12 intervention groups was weeks 0.2 lower (0.42 lower to 0.02 higher)

Relapse: Relapse for any Study population RR 1.67 88 ⊕ reason (medium term) (0.62 to 4.48) (1 study) very low1,2,3 Follow-up: 12-52 weeks 125 per 10004 209 per 1000 (78 to 560)

Moderate

125 per 10004 209 per 1000 (78 to 560) 28 oyih 05TeCcrn olbrto.Pbihdb J by Published Collaboration. Cochrane The ill 2015 mental © serious Copyright with people for (brief) Psychoeducation

Mental state: 2b. Spe- The mean mental state: The mean Mental state: 88 ⊕ cific - average endpoint average positive score in specific- average end- (1 study) very low1,2,3 PANSS scores (high = the control groups was point PANSS scores poor) - short term - pos- 11.3 points. (high = poor)-short itive score term-positive score in Follow-up: up to 12 the intervention groups weeks was 0.10 higher (1.72 lower to 1.92 higher)

Quality of life: 1a. Aver- The mean quality of life- The mean Quality of life: 63 ⊕ age endpoint scores on short term in the control average endpoint scores (1 study) very low1,2,3 various scales (MSQoL- groups was on various scales- short

es(Review) ness 54, high = good) - short 52.8 points. term in the intervention term groups was 1.80 higher h ie os Ltd. Sons, & Wiley ohn Follow-up: up to 12 (10.17 lower to 13.77 weeks higher)

GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

1 Risk of bias: rated ’serious’ - one included study rated as a ’high’ risk of bias across two of the ’Risk of bias’ domains, including incomplete outcome data and selective reporting. 2 Imprecision: rated as ’serious’, too small sample size. 3 We strongly suggested a publication bias because only one studies was included. 4 Assumed risk: median control group risk presented from studies, as little variation in baseline risk across studies (12.5%). 29 DISCUSSION 1.3. Knowledge Again, skewed data draws uncertainty onto any results due to un- even distribution - therefore, where results are descriptively stated Summary of main results in ’other tables’, data are not pooled with similar outcomes. Such skewed data needs interpreting with caution. With what we could use from the included studies, sample sizes were too small to de- 1. ANY FORM OF BRIEF PSYCHOEDUCATION tect any meaningful significance in the results; data from the (In- versus ROUTINE CARE/INFORMATION sight Treatment Attitude Questionnaire) (ITAQ) scale does in- See Summary of findings table 1 for grading of the quality of the dicate a trend that people receiving brief psychoeducation have evidence relating to our primary outcomes of interest. significantly better knowledge and understanding of the illness, again to be read in the light of the small study population (n = 97). The result may also be affected by attrition bias and selective 1.1. Compliance reporting. Based on our results, compliance with medication was shown to be significantly better in participants receiving psychoeducation, with significantly fewer people receiving psychoeducation not comply- 1.4. Global state ing with their medication regimen in the short term based on a Follow-up data at long-term (at two years) using the Global As- sample size of n =448. This may produce attrition and reporting sessment Scale (GAS) significantly favoured the psychoeducation bias on the result. This significant benefit also extended to the group, but results are from a small sample size (n = 59). Other medium term. The sensitivity analysis also shows that more rigor- data from the Global Assessment of Functioning (GAF) or GAS ous studies with large sample size are required. However, as regards demonstrated no significant difference. A consistent approach to the majority of our primary outcome measures of compliance is recording data would greatly help understand findings. Due to a concerned, there was no difference in the estimate of the effect serious risk of bias, inconsistency and imprecision, the quality of for levels of compliance measured using continuous rating scales, evidence is very low. One included study was rated as high risk due nor partial non-compliance. This conclusion is not robust due to to incomplete data. This may induce serious attrition bias to the the sparse data, and the wide confidence interval for overall effect result. A wide confidence interval of the overall effect also impacts also demonstrated the result as lack of precision. Furthermore, the precision of the result. significant outcomes have been identified across degrees of compliance (i.e. ’very good compliance’ significantly in favour of brief psychoeducation) at one-year and two-year follow-up. As regards 1.5. Service utilisation compliance with follow-up, there seemed to be no significant dif- Only two studies provided data on this important outcome, which ference between groups for those lost to follow-up by medium could provide a level of understanding regarding service utilisation term (n = 322), by one year (n = 386) and bytwo2 years (n = and associated resource use - an important factor when consider- 387). Fewer participants in the psychoeducation group left the ing economic viability of the intervention. Data demonstrate no study early after receiving the intervention than those in routine significant difference between groups; the result may be under- care group. For short-term compliance with follow-up, the results powered because of too small sample size. showed no significance between groups; however, this is likely due to the sparse data resulting in a wide confidence interval, more 1.6. Mental state data for this outcome should be reported in the future studies. Generally, studies indicated a greater improvement for participants in the psychoeducation group compared with those allocated to 1.2. Relapse standard care, but the differences in overall reduction were small, By replacing assumptions with completer-only data, relapse was and the clinical significance of a difference of this magnitude may significantly greater by medium term amongst participants receiv- be questioned. The quality of evidence was rated as low because of ing routine or standard care (n = 406); the quality of evidence is serious imprecision and strongly detected publication bias. One moderate because of serious risk of bias across studies. However study (n = 118) demonstrated a better general well-being and self- longer-term follow-up (at one and five years) demonstrated no esteem in the psychoeducation group rather than the routine care difference (n = 124). The small sample size indicates an inaccu- group. The reliability of this result may be compromised by the racy of the result. The result is also likely to be confounded with small sample size and unclear risk of bias across most of domains. performance bias, detection bias and reporting bias. As it stands Only one study reported the outcome on specific mental state with the current data, it is unclear how effective any form of brief symptoms of anxiety and depression (Both - Zhang 2004); results psychoeducation is compared with routine/standard care - partic- suggested that less participants in the psychoeducation group suf- ularly for the longer term. fered from these symptoms and that brief psychoeducation can

Psychoeducation (brief) for people with serious mental illness (Review) 30 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. decrease the level of both symptoms. As with all findings from a 2.ANY FORM OF BRIEF PSYCHOEDUCATION few small studies, these findings should be replicated before being versus Cognitive Behavourial Therapy (CBT) considered reliable and conclusive. Only one study provided data for this comparison, there is no statistical difference between psychoeducation and CBT for compliance, relapse, hospitalisation, mental state and patients’ quality of 1.7. Social functioning life. The quality of the evidence is very low because of serious risk Results from one small study supported that brief psychoeducation of bias, wide confidence interval and suspected publication bias. can improve the patients social function such as rehabilitation However, this result may not indicate a similar effect between the status and social disability; because of the small sample size (n = two groups, but may be caused by the small sample size resulting in 118) of the only included study, this result has serious imprecision a wide confidence interval. So more data are required to compare and this positiveness is likely ascribe to publication bias. So the the difference between brief psychoeducation and CBT. quality of evidence was downgraded and rated as low. 3. SUBGROUP ANALYSIS: GROUP PSYCHOEDUCATION/ INDIVIDUAL 1.8. Expressed emotion PSYCHOEDUCATION versus ROUTINE The one study that provided data for this outcome (n = 46, Group CARE/INFORMATION - Merinder 1999) did not demonstrate and significant differences Indirect comparisons of the 13 studies that provided data for our between groups. Without more data, it is difficult to conclude if primary outcomes of interest were undertaken, comparing any psychoeducation is indeed better than standard care on reducing difference in the estimate of effect with either individual brief psy- expressed emotion in relatives. choeducation versus group brief psychoeducation. These findings were, however, not direct comparisons, and were not well powered and serve only to generate theories for future studies. 1.9. Quality of life Data tended to favour the brief psychoeducation group in medium-term improvement for quality of life. although measured 3.1 Compliance by two different scales. The short-term quality of life is similar be- We found no convincing evidence that those given psychoed- tween groups. Consistency of measures and more data are needed ucation in a group differed in terms of compliance with those before confidence can be drawn on the effects of brief psychoe- where the intervention was delivered individually. However, the ducation and quality of life. Because of a small sample size (n = one study that delivered the intervention ’both’ as a group and 62), imprecise result and suspected publication bias, the quality individually did demonstrate statistical significance in favour of of evidence was rated as very low. brief psychoeducation in the medium term (n = 118, Both - Liu 2004). Again, these results serve as an indirect comparison, with no definitive conclusions to be drawn just yet. 1.10. Satisfaction with care

All data for levels of satisfaction with care derive from only one 3.2 Relapse of the included studies (n = 46, Group - Merinder 1999); data Group-delivered brief psychoeducation can result in an short-term indicated an equivocal effect between groups. This is an important improvement for relapse, however this improvement was not ob- outcome, and much more data are needed to understand how served in either the long-term measurement nor in individual-de- psychoeducation really effects this outcome. livered psychoeducation. This may due to the insufficient data, more data should be collected before a definitive conclusion. 1.11. Adverse events: death Across the time periods of the few studies that reported on this 4. Sensitivity analysis outcome (about two years), approximately 1% of people died. There was no suggestion that psychoeducation had any effect on this outcome.Two included studies were rated as high risk in the 4.1 Implication for randomisation domain of “blinding” and “incomplete data”.These may introduce There is no significant difference by removing the studies that performance or detection bias. Coupled with a wide confidence implied randomisation (Group - Chan 2007; Group - Razali interval which indicates a imprecise result, the quality of evidence 1995), which means that the randomisation of included studies was downgraded as low. was acceptable and did not generate further bias.

Psychoeducation (brief) for people with serious mental illness (Review) 31 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 4.2. Asumption for lost binary data Quality of the evidence Apart from relapse rate for any reason, there is no significant dif- Overall, the quality of reporting was low; half of the included stud- ference between the assumed data and completer-only data, which ies did not describe how the randomisation was conducted. Blind- means that the assumed data were acceptable and did not produce ing was only mentioned in one study and blinding concealment further bias (Analysis 4.1). was not tested. Therefore, there is a moderate risk of overestimat- ing the estimate of effect. For some outcomes, imprecision and publication bias were considered serious enough to warrant down- 4.3.Risk of bias grading quality of evidence. Please refer to Figure 2 and Figure After removing studies with a high risk of bias, there were no longer 3 for a graphic representation of the methodological quality of significant differences between brief psychoeducation and routine included studies. The quality of evidence gradings for main out- care groups in short-term compliance to medication and relapse comes of interest are also presented in Summary of findings for rate. Based on the values of overall effect and confidence intervals, the main comparison and Summary of findings 2. we attribute these disagreements to the decrease of total sample size (from n = 448 to n = 60) (Analysis 5.1). Potential biases in the review process 4.4 Fixed and random effects The process of searching for studies was thorough. We strictly There was no difference in the estimate of the effect when a ran- followed the review protocol in the process of study selection, data dom-effects model was used for data synthesis instead of a fixed- extraction and analysis. However, we only worked with published effect model in compliance and other outcomes, which means that reports in this review and may be perpetuating a publishing bias. fixed random effects is acceptable for the data analysis. Half of the included studies were from the People’s Republic of China. The quality of some of the Chinese trials has been called into question (Wu 2006), as many that are stated to be randomised Overall completeness and applicability of are not. evidence

Agreements and disagreements with other 1. Completeness studies or reviews As regards our primary outcomes of interest, most included studies This review largely concurs with ﬁndings from the previous related reported data for compliance, with just under half reporting onthe Cochrane review (Xia 2011). outcome of relapse. More binary data and less, or even more con- sistently-reported, continuous data would be widely welcomed for a review such as this - it difﬁcult to make concrete decisions as to the estimate of the effect when the evidence provided within study reports are inconsistent with each other. More data on participant AUTHORS’ CONCLUSIONS satisfaction with services or care would be needed to accompany the other patient-oriented outcomes that this intervention seeks Implications for practice to provide. Policy makers will certainly want more and better reported economic data. 1. For people with schizophrenia

For schizophrenia patients in China, Germany, Denmark, Pak- 2. Applicability istan, Scotland and Malaysia, brief psychoeducation may improve Most trials were undertaken in hospital, whereas the majority of short-term and medium-term compliance with medication as well people with schizophrenia are treated in the community. We are as the degree of compliance with medication. Whether brief psy- unsure that, in the context of well-functioning community ser- choeducation can improve the compliance with follow-up remains vices, psychoeducation, as a separate package, has a place. This is uncertain. In the medium term, brief psychoeducation can reduce the sort of information that would not be difficult to generate. the risk of relapse, but the long-term effect remains unclear because As regards a context in which fully-functioning community ser- of insufficient evidence. The patients’ knowledge on schizophrenia vices do not exist, further evidence is needed from such countries may also be improved by brief psychoeducation. Insufficient data and contexts in order to clarify how far a brief psychoeducation supported that brief psychoeducation: i) can improve the long- package would be effectively received, in terms of compliance with term global state; ii) has no effect for rehospitalisation; iii) can medication, relapse and other global state outcomes. achieve a short-term and medium-term greater improvement for

Psychoeducation (brief) for people with serious mental illness (Review) 32 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. mental state; iv) has a better general well-being and self-esteem; 2. Specific and v) can lower the incidence and severity of anxiety and de- See Table 1 for a suggested design of future study, modified from pression. Social function such as rehabilitation status and social that included in the full version of the Cochrane psychoeducation disability were also improved by brief psychoeducation. A greater review (Xia 2011). The key difficulty in assessing the efficacy of medium-term improvement of quality of life was also observed in a brief psychoeducational approach is the heterogeneity between the psychoeducation group; adverse events were similar between studies regarding the delivered intervention. Surprisingly, hetero- psychoeducation and routine care group. As far as this review is geneity was not found to be a huge problem in the results of this concerned, data from 20 studies are not strong enough to con- review; however, well-standardised brief psychoeducational pro- clude with any certainty the benefits that may be received from grammes with clear definitions of the content of interventions to participating in this therapy. Larger studies are needed to confirm help professionals planning evidence-based psychoeducational in- or refute any benefit. Unreliable evidence supported that brief psy- terventions, people with schizophrenia and family members par- choeducation has similar effects with CBT for compliance, relapse, ticipating in psychoeducation programmes will go a long way re-hospitalisation, mental state and quality of life. to determining the true effect of this intervention. Furthermore, any continuous measures must be consistent, using internationally-recognised, peer-reviewed rating scales, and include full re- 2. For clinicians ports with means and standard deviations. It is clear that larger studies are needed, with more research into specific participant It is not possible to say with a degree of certainty the true benefits populations, including acute and treatment-resistant people with that people with schizophrenia will obtain from a brief psychoe- schizophrenia, as current evidence is lacking. It is also clear that ducational approach. Evidence does suggest better compliance in economic evidence is tantamount, and comes hand-in-hand when the short term and lower relapse rates in the medium term with considering efficacy of a new treatment in the treatment of serious the intervention than without it; however, studies were not highly- mental illness. powered enough, with small sample sizes and varying times in Table 2 also shows where excluded studies in this area could be which the interventions were delivered, to confirm this. included either in reviews already underway or in reviews for the future, which when complete can help provide an overview of research and evidence in this area. 3. For managers and policy makers Few data exist concerning the economic consequences of imple- menting brief psychoeducation as a routine service. More extensive economic research should be undertaken in this area to explore ACKNOWLEDGEMENTS the true costs of the brief version of the intervention as compared The Cochrane Schizophrenia Group Editorial Base in Notting- to a longer version, to more accurately consider any cost-benefit. ham produces and maintains standard text for use in the Meth- ods section of their reviews. We have used this text as the basis Implications for research of what appears here and adapted it as required. The search term was developed by the Trial Search Co-ordinator of the Cochrane Schizophrenia Group and the contact author of the original pro- 1. General tocol. We would like to thank Raija Kontio and Lilas Ali for peer re- Adherence to CONSORT for good reporting of clinical trials more viewing this version of the review. Athfah Akhtar helped with data closely would have helped to considerably increase the amount of extraction of two included studies, we would like to acknowledge data available in this review. and thank her for her contribution.

References to studies included in this review Group - Bechdolf 2004 {published data only} Bechdolf A, Knost B, Kuntermann C, Schiller S, Both - Liu 2004 {published data only} Hambrecht M, Klosterkotter J, et al. Coping-oriented Liu L, Gao CF, Yue SY, Zhan LY, Liu WG. Effect of family versus psychoeducational group therapy for post acute intervention on rehabilitation of schizophrenic patients in patients with schizophrenia: results of a 6 month follow-up. community. Journal of Nursing Science 2004;3(19):3–6. Schizophrenia Research 2002;53:264–5. ∗ Bechdolf A, Knost B, Kuntermann C, Schiller S, Both - Tom 1989 {published data only} Klosterkotter J, Hambrecht M, et al. A randomized Tom L. Psychoeducational approach with chronically comparison of group cognitive-behavioural therapy and mentally ill Chinese-Americans: a cultural framework. PhD group psychoeducation in patients with schizophrenia. Acta dissertation submitted to the City University of New York, Psychiatrica Scandinavica 2004;110(1):21–8. USA 1989:161. Bechdolf A, Knost B, Nelson B, Schneider N, Veith V, Yung AR, et al. Randomized comparison of group cognitive Both - Zhang 2004 {published data only} behaviour therapy and group psychoeducation in acute Zhang L, Ren QL, Li CP, Yao N, Han FZ. Improvement patients with schizophrenia: effects on subjective quality of of anxiety and depression in patients with schizophrenia at life. Australian and New Zealand Journal of Psychiatry 2010; recovery stage via education of health conviction mode. 44:144–50. Journal of Nursing Science 2004;19(15):51–3. Bechdolf A, Kohn D, Knost B, Pukrop R, Klosterkotter J. Group - Aguglia 2007 {published data only} A randomized comparison of group cognitive-behavioural Aguglia E, Pascolo-Fabrici E, Bertossi F, Bassi M. therapy and group psychoeducation in acute patients with Psychoeducational intervention and prevention of relapse schizophrenia: outcome at 24 months. Acta Psychiatrica among schizophrenic disorders in the Italian community Scandinavica 2005;112:173–9. psychiatric network. Clinical Practice and Epidemiology in Group - Chan 2007 {published data only} Mental Health 2007;3:1745–79. Chan SH-W, Lee SW-K, Chan IW-M. TRIP: a psycho- Group - Bauml 2007 {published data only} educational programme in Hong Kong for people with Bauml J, Kissling W, Buttner P, Pitschel Walz G, Boerner schizophrenia. Occupational Therapy International 2007;14 R, Engel R, et al. Specific effects of psychoeducational (2):86–98. groups on the relapse rates of schizophrenic patients. Group - Chan 2009 {published data only} Pharmacopsychiatry 1995;28:161. Chan S W, Yip B, Tso S, Cheng BS, Tam W. Evaluation Bauml J, Kissling W, Buttner P, Schlag K, Pitschel Walz G, of a psychoeducation program for Chinese clients with Borner R, et al. Psychoeducational groups for schizophrenic schizophrenia and their family caregivers. Patient Education patients and their relatives: influence on compliance, rate and Counselling 2009;75:67–76. of rehospitalization and social functioning (PIP-study, Munchen). Pharmacopsychiatry 1993;26:140. Group - Coyle 1988 {published data only} Bauml J, Kissling W, Pitschel-Walz G. Psychoeducational Coyle P. A comparative analysis of varying treatment groups among schizophrenic patients: Influence on approaches on the level of community adjustment among knowledge and compliance. Results of the Munich PIP schizophrenic outpatients. PhD dissertation submitted to study. Nervenheilkunde 1996;15:145–50. the Adelphi University, USA 1988:136. Bauml J, Pitschel-Walz G, Kissling W. Group Group - Dai 2007 {published data only} psychoeducation in schizophrenic psychoses. Psycho 1997; Dai JQ. Health education on compliance of schizophrenic 23:38–45. patients. Medical Journal of Chinese People’s Health 2007; ∗ Bauml J, Pitschel-Walz G, Volz A, Engel RR, Kessling Vol. 19, issue 12:1089–90. W. Psychoeducation in schizophrenia: 7-year follow-up concerning rehospitalization and days in hospital in the Group - Hornung 1995 {published data only} Munich Psychosis Information Project Study. Journal of Buchkremer G, Klingberg S, Holle R, Monking HS, Clinical Psychiatry 2007;68:854–61. Hornung WP. Psychoeducational psychotherapy for Pitschel-Walz G, Bauml J, Bender W, Engel R R, Wagner schizophrenic patients and their key relatives or care-givers: M, Kissling W. Psychoeducation and compliance in the results of a 2-year follow-up. Acta Psychiatrica Scandinavica treatment of schizophrenia: results of the Munich Psychosis 1997;96(6):483–91. Information Project Study. Journal of Clinical Psychiatry Feldmann R, Buchkremer G, Hornung WP. Cognitive 2006;67:443–52. deficits of schizophrenic patients as predictors of the Pitschel-Walz G, Boerner R, Mayer C, Wagner M, Engel course of illness after psychoeducational psychotherapeutic RR, Peuker I, et al. Effects of psychoeducational groups for interventions [Prognostische und therapeutische schizophrenic patients and their relatives on knowledge, relevanz kognitiver ressourcen fur den langenzeitverlauf compliance and relapse. Pharmacopsychiatry 1995;28:204. schizophrener erkrankung nach psychoedukativ–

Psychoeducation (brief) for people with serious mental illness (Review) 34 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. psychoterapeutischer behandlung]. Fortschritte der Knowledge, Satisfaction With Services and Clinical Outcome Neurologie Psychiatrie 2000;68(2):54–60. in Schizophrenia. Faculty of Health Sciences, University of Hornung WP, Buchkremer G, Redbrake M, Klingberg Aarhus, Department of Psychiatric Demography, Institute S. Patient modified treatment. What are the effects for Basic Psychiatric Research. Psychiatric Hospital in of neuroleptic drugs on people with schizophrenia? Aarhus, 2000. [Patientmodifizierte medikation: Wie gehen schizophrene Merinder LB, Viuff AG, Laugesen H, Clemendsen K, patienten mit ihren neuroleptika um?]. Nervenarzt 1993; Misfelt S, Espensen B. Effects of psychoeducative methods: 64:434–9. a randomized controlled study. Nordisk Psykiatrisk Tidsskrift Hornung WP, Feldmann R, Klingberg S, Buchkremer 1998;52:144. G, Reker T. Long term effects of a psychoeducational ∗ Merinder LB, Viuff AG, Laugesen HD, Clemmensen psychotherapeutic intervention for schizophrenic K, Misfelt S, Espensen B. Patient and relative education outpatients and their key persons: results of a five year in community psychiatry: a randomized controlled trial follow-up. European Archives of Psychiatry and Clinical regarding its effectiveness. Social Psychiatry and Psychiatric Neuroscience 1999;249:162–7. Epidemiology 1999;34:287–94. Hornung WP, Feldmann R, Schonauer K, Schafer A, Merinder LB, Viuff AG, Laugesen HD, Clemmensen Monking HS, Klingberg S, et al. Psychoeducational K, Misfelt S, Espensen B. Patient and relative education psychotherapeutic treatment of schizophrenic patients and in community psychiatry; a randomised trial regarding their caregivers. II. Supplementary findings at a 2 year its usefulness. Proceedings of the 9th Congress of the follow up. Der Nervenarzt 1999;70:444–9. Association of European Psychiatrists; 1998 Sep 20-24; ∗ Hornung WP, Holle R, Schulze Monking H, Klingberg Copenhagen, Denmark. 1998. S, Buchkremer G. Psychoeducational-psychotherapeutic treatment of schizophrenic patients and their caregivers. Group - Razali 1995 {published data only} Results of a one-year catamnestic study. Der Nervenarzt ∗ Razali MS, Yahua H. Compliance with treatment in 1995;66:828–34. schizophrenia: a drug intervention program in a developing Hornung WP, Kieserg A, Feldman R, Buchkremer G. country. Acta Psychiatrica Scandinavica 1995;91:331–5. Psychoeducational training for schizophrenic patients: Razali SM, Yahua H. Health education and drug counselling background, procedure and empirical findings. Patient for schizophrenia. International Medical Journal 1997;4(3): Education and Counseling 1996;29:257–68. 187–9. Hornung WP, Klingberg S, Feldmann R, Schonauer K, Schulze Monking H. Collaboration with drug treatment by Group - Zhang 2006 {published data only} schizophrenic patients with and without psychoeducational Zhang H, Wang P, Wu Z. Influence of health education training: results of a 1-year follow-up. Acta Psychiatrica on compliance of orally taking medicines in schizophrenia Scandinavica 1998;97:213–9. patients of the first episode seeing doctor in out-patient Hornung WP, Schonauer K, Feldmann R, Monking HS. clinic. Chinese Nursing Research 2006;20(5):1246–7. Medication-related attitudes of chronic schizophrenic patients. A follow-up study after psycho-educational Individual - Cunningham 2001 {published data only} intervention [Medikationsbezogene einstellungen chronisch Cunningham Owens DG, Carroll A, Fattah S, Clyde Z, schizophrener patienten. Eine follow–up untersuchung 24 Coffey I, Johnstone EC. A randomized, controlled trial of a monate nach psychoedukativer Intervention]. Psychiatrische brief interventional package for schizophrenic out-patients. Praxis 1998;25(1):25–8. Acta Psychiatrica Scandinavica 2001;103(5):362–9. Klingberg S, Buchkremer G, Holle R, Schulze-Monking Individual - Macpherson 1996 {published data only} H, Hornung WP. Differential therapy effects of Macpherson R, Jerrom B, Hughes A. A controlled study of psychoeducational psychotherapy for schizophrenic education about drug treatment in schizophrenia. British patients: results of a 2 year follow up. European Archives of Journal of Psychiatry 1996;168:709–17. Psychiatry and Clinical Neuroscience 1999;249(2):66–72. Group - Li 2003 {published data only} Individual - Nasr 2009 {published data only} Li FM, Xu JH. Comparative study on the effect of family Nasr T, Kausar R. Psychoeducation and the family burden intervention on schizophrenia patients in convalescence and in schizophrenia: a randomized controlled trial. Annals of their family members. Health Psychology Journal 2003;11 General Psychiatry 2009;8:17. (2):129–30. Group - Lv 2007 {published data only} Unclear - Li 2005 {published data only} Lv C-M, Lu D-C, Lv W-Q, Jin L-Z, Zheng Q-L. Effects Li H. Systematic psychoeducation for medication of follow- up on family function of schizophrenia patients’ compliance in patients with schizophrenia. Journal of Qilu families and their quality of life. Nanfang Journal of Nursing Nursing 2005;11(7B):897–8. 2007;14(9):7–9. Group - Merinder 1999 {published data only} References to studies excluded from this review Merinder LB. Impact of Patient and Relative Education on

Psychoeducation (brief) for people with serious mental illness (Review) 35 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Carra 2010 {published data only} Pfammatter 1999 {published data only} ∗ Carra G. Multiple group family treatment for Pfammatter M, Andres K, Brenner HD. Evaluation of schizophrenia in Italy. Schizophrenia Research 2010;117: psychoeducative and coping-oriented group therapy for 121. patients with schizophrenic and schizoaffective disorders: a Carra G, Montomoli C, Clerici M, Cazzullo CL. Family multi centre study. Schizophrenia Research 1999;36:331. interventions for schizophrenia in Italy: randomized controlled trial. European Archives of Psychiatry and Clinical Pitschel-Walz 2013 {published data only} Neuroscience 2007;257:23–30. Pitschel-Walz G, Gsottschneider A, Frobose T, Kraemer S, Bauml J, Jahn T. Neuropsychology of psychoeducation in Chabannes 2009 {published data only} schizophrenia: Results of the Munich COGPIP study. 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Community mental health in China : a with schizophrenia. Psychiatric Services (Washington, D.C.) randomized controlled trial of psychoeducational family 2004;55:1276–84. intervention for carers of persons with schizophrenia in a Chien WT, Chan SWC, Thompson D R. Effects of a rural area in Chengdu [thesis] 2002. mutual support group for families of Chinese people with Ran M, Xiang M, Huang M. A control study of schizophrenia: 18-month follow-up. British Journal of psychoeducational family intervention for relatives of Psychiatry 2006;189:41–9. schizophrenics in a Chinese rural community. Chinese Chien WT, Lee IY. The mindfulness-based psychoeducation Journal of Psychiatry 2001;34:98–101. program for Chinese patients with schizophrenia. PsychiatrIc ∗ Ran MS, Xiang MZ, Chan CL, Leff J, Simpson P, Huang ServIces 2013;64(4):376–9. M S, et al. Effectiveness of psychoeducational intervention Chien WT, Leung SF. A controlled trial of a needs-based, for rural Chinese families experiencing schizophrenia. A nurse-led psychoeducation programme for Chinese patients randomised controlled trial. Social Psychiatry and Psychiatric with ﬁrst-onset mental disorders: 6 month follow up. Epidemiology 2003;38:69–75. International Journal of Nursing Practice 2013;18:3–13. Fries 2003 {published data only} Rotondi 2005 {published data only} Fries A, Pfammatter M, Andres K, Brenner HD. Outcome Rotondi AJ, Haas GL, Anderson CM, Newhill CE, Spring and process characteristics of a psychoeducational, coping MB, Ganguli R, et al. A clinical trial to test the feasibility oriented group therapy for schizophrenia and schizoaffective of a telehealth psychoeducational intervention for persons patients. Verhaltenstherapie 2003;13(4):237–43. with schizophrenia and their families: intervention and 3- month ﬁndings. Rehabilitation Psychology 2005;50:325–36. 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Psychoeducation (brief) for people with serious mental illness (Review) 36 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Xiang 1994 {published data only} Nischk 2011 {published data only} Xiang M, Ran M, Li S. A controlled evaluation of Nischk D, Gasser M, Polaine K, Rusch J, Schonauer K, psychoeducational family intervention in a rural Chinese Rockstroh B. Effects of a brief psychoeducative intervention community. British Journal of Psychiatry 1994;165:544–8. for acute psychotic patients. Zeitschrift fur klinische 2011;40:1616–3443. Ying 2006 {published data only} Psychologie und Psychotherapie Ying Z P,Wu DC. A control study psychoeducational family Pitschel-Walz 1993 {published data only} intervention for relatives of schizophrenics in a Chinese Bauml J, Kissling W, Buttner P, Schlag K, Pitschel Walz G, rural community. Chinese Journal of Primary Medicine Borner R, et al. Psychoeducational groups for schizophrenic Pharmacy 2006;13:819–20. patients and their relatives: influence on compliance, rate of rehospitalization and social functioning (PIP-study, References to studies awaiting assessment Munchen). Pharmacopsychiatry 1993;26:140. Pitschel-Walz G, Boerner R, Mayer C, Engel R, Peuker Bechdolf 2000 {published data only} I, Welschehold M, et al. Psychoeducational groups for Bechdolf A, Knost B, Pukrop R, Hambrecht M, schizophrenic patients and their relatives: influence on Klosterkotter J. Coping strategy orientated therapy versus knowledge, attitudes and familial expressed emotions. psychoeducational group therapy of post acute patients with Pharmacopsychiatry 1993;26:186. schizophrenia or schizoaffective disorders: initial resultsofa Pitschel-Walz 1997 {published data only} randomised study. Der Nervenarzt 2000;71:379. Pitschel-Walz G, Engel R R. Psychoeducation in the Cormier 1995 {published data only} treatment of schizophrenia. 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A family support and psychoeducation service compliance programs. http://www.controlled-trials.com for schizophrenia: effectiveness and training. National 2007. Research Register 2000. Lacruz 1999 {published data only} Wirshing 2000 {published data only} Lacruz M, Masanet MJ, Bellver F, Asencio A, Ruiz I, Iborra Wirshing D, Rossoto E, Wirshing WC, Gonzalez L. M, et al. Changes in the knowledge of the key relatives The community re-entry program for schizophrenia: about schizophrenia after a psychoeducational family preliminary findings. Conference proceedings. 2000. intervention. Archivos de Neurobiologia 1999;62:49–64. Wirshing 2002 {published data only} Mihai 2005 {published data only} Wirshing DA, Wirshing WC, Rossoto E, Gonzalez L, Mihai A, Nirestean A. Psychoeducation improve patient Watson J, Ballon J, et al. The community re-entry compliance to psychiatric treatment. (conference abstract program for schizophrenia: correlates of treatment response. only). 2005. 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Characteristics of included studies [ordered by study ID]

Both - Liu 2004

Methods Allocation: randomised - no further description. Blindness: not stated. Duration: 6 months. Setting: JiNing Psychiatric Prevention Hospital, China.

Participants Diagnosis: schizophrenia (CCMD-3). n = 118. Age: average age ~ 41years (SD ~ 9). Sex: male and female. History: average length of illness ~ 14.5 years (SD ~ 9). Inclusion: living in JiNing city district with relative; stabilised condition, BPRS score < 30. Exclusion: patients with heart, liver, renal impairment, drug or alcohol dependency

Interventions 1. Family intervention + routine rehabilitation therapy: 60-90 minutes/month, for 6 months in the form of outpatient home visit: familiarise patients with basic knowledge of schizophrenia; provide patients with individualised guidance on communication skills, common drug adverse events and coping strategies, as well as how to recognise early warning signs of relapse; answer family members’ enquiries regarding patients behaviour and social functioning; organise seminars for patients and family to exchange experience (two seminars in total run at 2-3 hours each), n = 59 2. Routine rehabilitation therapy, n = 59.

Outcomes Mental state: GWB, SES. Social functioning: MRSS, SDSS. Unable to use - Knowledge: increase (unpublished scale). Compliance: (unpublished scale).

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomised, but no detail described. bias)

Allocation concealment (selection bias) Unclear risk Not described.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) Low risk No incomplete outcome data. All outcomes

Selective reporting (reporting bias) Low risk All measured outcomes were reported.

Other bias Unclear risk None obvious.

Both - Tom 1989

Methods Allocation: randomised. Blinding: not stated. Duration: 5 weeks. Setting: outpatient mental health service, New York city’s Chinatown

Participants Diagnosis: schizophrenia (DSM-III). n = 30. Age: treatment group - mean 34.08 years, range 18-56 years; control group - mean 36. 67 years, range 26-60 years Sex: M 19, 5 F. History: (length of illness) treatment group - mean 11.25 years, range 1-29 years; control group - mean 16 years , range 1-35 years Included: Chinese speaking Excluded: not stated.

Interventions 1. Continuing treatment program + psychoeducation: content included: continuing treatment program, psychotherapy, occupational and recreational therapy with a specialised cultural orientation, skills of daily living, English language class, arts and crafts, cultural activities,etc; psychoeducation, group presentation (lecture with a slide show) ; individual sessions with a interview schedule, eight group sessions and one individual session over 5 weeks, n = 15 2. Continuing treatment program: psychotherapy; occupational and recreational therapy with a specialised cultural orientation, skills of daily living, English language class, arts and crafts, cultural activities; scheduled daily, n = 15

Outcomes Compliance - leaving the study early; lost to follow-up Knowledge of mental illness and treatment- KSQ Satisfaction with services- CSQ-8 Unable to use Motivation for treatment - TCL (instrument non-validated) Attitude toward mental illness- OMI (instrument non-validated)

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Randomised: the ﬁrst name drawn and as- bias) signed to either Interveniton group or control group

Allocation concealment (selection bias) Unclear risk Not reported.

Blinding of participants and personnel Unclear risk Not reported. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not reported. bias) All outcomes

Incomplete outcome data (attrition bias) High risk Leaving the study early: Intervention All outcomes group: n =- 3 excluded as did not attend the sufﬁcient sessions; Control group: n = 3 for failure to attend or complete the program. No ITT analysis

Selective reporting (reporting bias) High risk No means or SDs reported for all outcomes scales - only data for attrition were usable in data and analysis

Other bias Unclear risk No further info.

Both - Zhang 2004

Methods Allocation: randomised - no further description. Blindness: not stated. Duration: 4 weeks. Setting: JiNing Psychiatric Prevention Hospital, ShangDong, China

Participants Diagnosis: schizophrenia (CCMD-3). n = 146. Age: average age ~ 37 years (SD ~ 11). Sex: male and female. History: length of illness 3 months - 10 years. Inclusion: patients with stabilised psychotic symptoms after systematic anti-psychotic medication, and most cognitive functioning have recovered; without medication side effects; can independently complete questionnaire. Exclusion: patients with either self- or drug-induced depression or anxiety

Interventions 1. Health belief model: this is delivered in the form of both group and individual therapy - i. analyse cause & nature of illness with patients; ii. guide patients to associate recovery with health education; encourage patients to participate in sports, entertainment activi-

ties and travel; help patients to develop hobbies; communicate their feelings with nurses or family, friends; 30 minutes/time, 2 times/week for 4 weeks. n = 74 2. Routine health education. n = 72.

Outcomes Social functioning: SAS; SDS, anxiety and depression incidence rate*

Notes *SAS score > 51 is considered as having anxiety; SDS score > 51 is considered as having depression

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomised, no further description. bias)

Allocation concealment (selection bias) Unclear risk Not described.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) Low risk No incomplete outcome data. All outcomes

Selective reporting (reporting bias) Low risk All measured outcomes were reported

Other bias Low risk None obvious.

Group - Aguglia 2007

Methods Allocation: randomised. Blindness: Single, only participants were blinded. Duration: 12 months. Setting: 15 Community Mental Health Centres in Italy.

Participants Diagnosis: Schizophrenia. n = 150. Age: 18 - 45. Sex: 35 F, 100 M, (Control: 21 F, 45 M and Experimental: 14 F, 55 M) History: undergoing standardised drug therapy. Included: diagnosed with schizophrenia in agreement with DSM IV and ICD. Exclusion: acute psychosis, substance abuse problems, organic factors that could inter- fere with clinical condition, patients currently participating in psychoeducational and

structured interventions or participated in the last 2 years (p4)

Interventions 1. Traditional psychosocial interventions, anti-psychotic drug treatment, 8 different parallel sessions of psychoeducational program 60-90 minutes each (n = 69) 2. Standard procedure: anti-psychotic drug treatment (dosage monitored every 6 months) and assertive community treatment (n = 66) Antipsychotic drug management: traditional and atypical antipsychotic drugs, administered alone or combined; also receive some “long acting” (haloperidol decanoate, ﬂuphenazine decanoate, zuclopenthixol decanoate) antipsychotic drugs

Outcomes Compliance: Leaving the study early. Service utilisation: Number of hospitalisations. Unable to use - Adherene: Rating of Medication Inﬂuences (ROMI): No means reported Mental state: BPRS, SAPS, SANS: no means reported. Social functioning: SAS - no means reported. QOL: Lancashire Quality of life scale: no means reported.

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk No description of random allocation pro- bias) vided.

Allocation concealment (selection bias) Unclear risk No information provided on allocation concealment.

Blinding of participants and personnel High risk Study participants were blind to randomi- (performance bias) sation. Quote: “The patients were blindly All outcomes randomised by the experimenter into two groups”. The authors have recommended a double-blind study. Quote: “Though the staff carrying out psychoeducation and standard psychosocial intervention and the staff administering the scales were different, the open label design of the study could bring some biases. A double blind study should be recommended”

Blinding of outcome assessment (detection Unclear risk Although the study is an open-label design, bias) the staff carrying out psychoeducation in- All outcomes tervention and the staff administering the scales were different

Incomplete outcome data (attrition bias) High risk No speciﬁc reasons given for dropouts (n All outcomes = 15). Quote: “135 patients ﬁnished the

study; 15 dropped out for different reasons unrelated to the study”. No mention of how attrition was addressed in the analysis. Quote: “The percentage of the participants hospitalised between 1 and 3 times during the 12 months resulted to be 13% after 6 months, and 3,3% after a year with a difference of 9.7% for the study group; while for the control group the variation went from 17.7% at 6 months to 10.5% after 1 year with an improvement of 7,2%”

Selective reporting (reporting bias) Unclear risk Most outcomes are reported but no clarity on number of participants used in the analysis

Other bias Unclear risk Funding: not stated.

Group - Bauml 2007

Methods Allocation: random. Blindness: blind to randomisation. Duration: 4 to 5 months, follow-up 12 and 24 months. Setting: multi-centre study, three psychiatric hospitals in Munich, Germany (1990-1994)

Participants Diagnosis: schizophrenia or schizophrenia disorder (DSM-III-R/ ICD-9) n = 236. Age: mean 34 ± 10.9 years. Sex: M 109, F 127. History: length of Illness mean 6.6 ± 6.0 years. Included: schizophrenia DSM-III-R; indication for an antipsychotic relapse prevention for a period of at least 12 months; age 18 and 65 years; patients’ agreement to undergo outpatient treatment at the study centre; patients’ agreement to invite a key relative or a friend Excluded: living at a distance of more than 150 kilometres from the hospital; less than 30 minutes’ contact per week with the key relative; drug addictions during the past 6 months prior to admission; pregnancy; IQ < 80; insufﬁcient knowledge of German; lack of remission of the psychotic symptoms during the previous 2 years despite an adequate therapy

Interventions 1. Psychoeducational group: delivered by separate therapists to patients and relatives; included emotional relief; take-home message; group discussion about coping strategies; information booklet; also received routine care. For patients: 60 min/session, 4 weekly sessions + 90-120min/session, 4 monthly. For relatives: 90-120 min/session, 8 biweekly sessions, n = 125 2. Routine care: outpatient treatment for all patients: Treatment as usual medication management, n = 111

Outcomes Compliance:Leaving the study early. Unable to use - Mental state:BPRS Global State: GAS (no means or SDs reported). Rehospitalisation rates; days in hospital (not reported by group)

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Group randomisation was done centrally; bias) the groups were formed independently in each study centre

Allocation concealment (selection bias) Low risk Randomisation was done centrally.

Blinding of participants and personnel Unclear risk Not reported. (performance bias) All outcomes

Blinding of outcome assessment (detection High risk Therapist not blinded. bias) All outcomes

Incomplete outcome data (attrition bias) High risk Dropout: 19 patients excluded for formal All outcomes reasons or due to premature discontinuation of the intervention, no ITT analysis

Selective reporting (reporting bias) Low risk All the outcome measures were reported.

Other bias Unclear risk Funding: German Ministry of Research and Technology (0701854 = 819754-3). The ﬁrst 2 years of the Psychosis Informa- tion (PIP) Study were supported by a grant from the German Ministry of Science and Research (BMFT). The long-term follow- up of the sub-sample from the TechnicalU- niversity of Munich was supported by a grant from the DORIST-Fondin Kreuzlin- gen, Switzerland

Methods Allocation: randomised. Blinding: rater-blind. Duration: 8 weeks delivery; 6- and 24-month follow-up. Setting: acute inpatient admissions, Department of Psychiatry and Psychotherapy, Uni- versity of Cologne (Germany) (July 1999 and December 2000)

Participants Diagnosis: acute schizophrenia or related disorder (ICD-10). n = 88. Age: PE - mean 31.4 ± 10.6 years; CBT - mean 32.2 ± 9.9 years Sex: PE - M 22, F 26; CBT M 18; F 22. History: PE - mean length of illness 50±58.7 months; CBT - mean length of illness 56. 7±65.4 months Included: age 18-64 years; episode of a schizophrenic or related disorder (ICD-10) Excluded: drug or alcohol dependence; organic brain disease; learning disability; hearing impairment; non-German speakers

Interventions 1. Group psychoeducational programme (PE)*: symptoms of psychosis; models of psychosis; effects and side effects of medication; maintenance medication;early symptoms of relapse; relapse prevention; 60 - 90 min/time, one time/week for 8 weeks, maximum 8 sessions, n = 48 2. Group cognitive behavioural therapy (CBT)*: delivered by an experienced and CBT trained psychiatrist or clinical psychologist; treatment of auditory hallucinations and delusions, associated symptoms and problems; relapse prevention and associated problems and enhancing medication compliance; 60 - 90 min/time, 2 sessions/week for 8 weeks, maximum 16 sessions, n = 40

Outcomes Compliance scale (4-point scale, used in other studies, rated by patient, relatives, psychiatric nurse and psychiatrist in charge) at pre-, post-treatment and 24-month follow- up Relapse rate (deﬁned as: rating of at least 5 and a 2-point increase compared with the previous assessment in at least one of the items of the positive syndrome sub scale of PANSS) at 6 months Mental state: PANSS at pre-, post treatment, 6 months after treatment and 24-month follow-up Medication use at pre, post treatment, 6 months after treatment and 24-month follow- up Quality of Life : Seven areas of MSQoL scores at pre, post, 6-month follow up Rehospitalisation rates at 6-month and 24-month follow-up.

Notes *Both interventions adjunct to routine hospital care; participants remained under medical supervision of the responsible consultant psychiatrist who alone determined the pharmacological regime, timing of discharge and readmission

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Random: quote “...by computer-generated bias) random numbers for blocks of eight participants, the results were placed in sealed envelopes and only opened at the time of treatment” (p22). Blind assessments by carrying out most of the assessments by independent raters

Allocation concealment (selection bias) Low risk Placed in sealed envelopes and only opened at the time of treatment allocation

Blinding of participants and personnel Unclear risk Quote, “with regard to psychopathology (performance bias) and compliance measures, we made at- All outcomes tempts to blind assessments by carrying out most of the assessments by independent raters who were not involved in the treatment” (p22)

Blinding of outcome assessment (detection Low risk Blind assessments by carrying out most of bias) the assessments by independent raters All outcomes

Incomplete outcome data (attrition bias) High risk n = 17 participants lost to follow-up. All outcomes

Selective reporting (reporting bias) High risk MSQoL not reported, will be reported else- where. Continuous scores for PANSS and compliance differ between published reports at 6 months and 24 months. Results from the 24-month report show signiﬁcant difference in results - data from the ﬁrst published report were used for short-term and medium-term outcomes

Other bias Low risk This work was supported by grant from the Koln For-tune Program (191/1998) Fac- ulty of Medicine, University of Cologne, Germany

Group - Chan 2007

Methods Allocation: randomised - no further description. Blinding: not stated. Duration: 2 weeks + 12 months follow-up. Setting: Pamela Youde Nethersole Eastern Hospital, Hongkong, China

Participants Diagnosis: schizophrenia (DSM-IV). n = 81. Age: 18-65 years. Sex: male and female. History: not stated. Exclusion: not stated.

Interventions 1. Psychoeducation: didactic presentation on mental health, schizophrenia, rehabilitation resources, medication management & compliance, relapse prevention & stress management; 50 minutes/session, 10 sessions. n = 44 2. Routine care. n = 37.

Outcomes Relapse. Knowledge: Insight-SAUMD scores. Unable to use - Quality of life: SF-36 (sub-scores only).

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomisation method not stated. bias)

Allocation concealment (selection bias) Unclear risk Not stated.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) Low risk No incomplete data. All outcomes

Selective reporting (reporting bias) Low risk All measured outcomes reported.

Other bias Low risk None obvious.

Methods Allocation: randomised. Blinding: not stated. Duration: 3 months treatment + 12 months follow-up. Setting: psychiatric outpatient department of a regional mental hospital, Hong Kong

Participants Diagnosis: schizophrenia (DSM-IV). n = 73. Age: 18-65 years (mean age 35.3±11.6). Sex: male (n = 48) and female (n = 25). History: not stated. Inclusion: clients had been diagnosed with schizophrenia by their attending psychiatrist and according to DSM IV within the previous 24 months, between the ages of 18 - 65, they were Hong Kong Chinese residents living with their families after discharge, were able to speak Cantonese, were will to participate in the study with their family caregivers + caregivers had to care for the client for at least 4 hours per day, live with the client, aged 18 or over, free from any mental disorders, be able to speak Cantonese, both client and caregiver had to agree to take part in the study together. Exclusion: clients with secondary diagnosis of a mental or physical disorder; caregivers were excluded if they were also currently providing care for another family member with a chronic physical or mental illness

Interventions 1. Psychoeducation + routine care: providing information on cause, development & treatment of schizophrenia, its recovery, relapse & early warning signs; 10 sessions over 3 months, n = 36 2. Routine care, n = 37.

Outcomes Mental state: BPRS endpoint scale score (data skewed). Knowledge: ITAQ endpoint scale score. Unable to use - Satisfaction: continuous satisfaction data - unclear from which scale they are derived from. Quality of life: FBIS endpoint scale score, no N number reported, data are skewed

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Random assignment generated by drawing bias) lots. Quote: “After their written consent was obtained, the participants were randomly assigned to experimental and control groups by drawing lots”

Allocation concealment (selection bias) Unclear risk Not stated.

Blinding of participants and personnel Unclear risk No clear description of blinding of partic- (performance bias) ipants or raters. Quote: “All the pre- and All outcomes post-tests were conducted by an assigned mental health nurse who was not involved in the intervention to avoid bias”. Not clear from this quote whether the mental health nurse was blind to intervention

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) Low risk No dropouts and no cases excluded. All outcomes

Selective reporting (reporting bias) High risk Some scale data (SSQ-6, SES) were not reported.

Other bias Low risk None obvious.

Group - Coyle 1988

Methods Allocation: randomised. Blindness: none reported. Duration: 6 months (10 sessions + 1 introductory and termination session used for data collection) Setting: outpatient mental health clinic, Jamaica.

Participants Diagnosis: schizophrenia. n = 94 (14 dropping out + incomplete data collection on 2 individuals). Age: 18-80 (mean age: 46.6, age range 21 to 72). Sex: M 40, F 38 . History: had been hospitalised before. Included: unemployed clients with a low income status, on psychotropic medication, primary diagnosis of schizophrenia and lived with at least one family member Exclusion: clients with a diagnosis of drug and/or alcohol abuse

Interventions 1. Psychoeducational + Psychotropic medication: educating individuals about the nature, aetiology and management of schizophrenia, n = 17 2. Psychotropic medication only: monthly brief (15 minutes or less) evaluation by the treating psychiatrist, n = 21 [3. Social skills training + Psychotropic medication: group therapy training individuals in social, coping and basic living skills and behaviours (n = 19). 4. Individual supportive therapeutic method + Psychotropic medication: supporting the individual by using problem- solving skills through techniques of verbal reinforcement and encouragement (n = 21).] - these groups not included in analysis.

Outcomes Leaving study early . Hospitalisation. Unable to use - Behaviour: KAS: unable to use as only means reported and no SD reported

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Stratified random assignment: stratified ac- bias) cording to age, sex, race. Then a stratified random assignment was performed ensuring there were equal numbers of participants in sub categories

Allocation concealment (selection bias) Unclear risk No allocation concealment from those delivering the intervention as all 3 workers delivering the intervention delivered all 3 interventions. No other allocation conceal- ments mentioned

Blinding of participants and personnel Unclear risk None reported. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not reported bias) All outcomes

Incomplete outcome data (attrition bias) Unclear risk Dropouts accounted for: In the individual All outcomes therapy group: n = 1 died of medical causes, n = 1 hospitalised, n = 1 did not complete the data. In the medication use group: n = 1 dropped out, n = 1 hospitalised, n = 1 did not complete the data; In the social skills training group: n = 3 dropped out, n = 1 hospitalised; In the psychoeducational group: n = 4 dropped out, n = 2 hospitalised. ITT analysis was not applied

Selective reporting (reporting bias) Unclear risk Only means reported with no SDs.

Other bias Unclear risk Funding: source not provided. Interested participants self-selected them- selves to be part of the study

Methods Allocation: randomised. Blinding: not stated. Duration: 8 weeks. Setting: Yangzhou Wutaishan Hospital, Jiangsu Province, China

Participants Diagnosis: schizophrenia (CCMD-3). n = 102. Age: not stated. Sex: not stated. History: not stated. Exclusion: severe physical or other mental illness.

Interventions 1. Psychoeducation + routine drug therapy: provide patients with information on cause, development & symptoms of illness, crisis strategy, communication with family member, maintain medication; 30-60 minutes/week. n = 51 2. Routine drug therapy. n = 51.

Outcomes Compliance: with medication. --Unable to use Behaviour: NOSIE score, the data and its interpretation are controversial in the original studies

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomisation method not stated. bias)

Allocation concealment (selection bias) Unclear risk Not stated.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) Low risk No incomplete outcome data. All outcomes

Selective reporting (reporting bias) High risk PANSS, ITAQ scores measured, but not reported.

Other bias Low risk None obvious.

Methods Allocation: randomised. Blinding: raters were not blind to the treatment conditions except compliance rated by independent raters at 1 year. Duration: 15 weeks and follow-up 5 years. Setting: Germany.

Participants Diagnosis: schizophrenia (DSM-III-R) with the exception of schizoaffective disorder. n = 191*. Age: mean 31.9 years, SD ~ 7.8 years. Sex: male and female. History: ’chronic’, outpatients, > 2 acute episodes in last 5 years, illness duration mean 8.3 years (SD 5.7), onset of illness mean ~ 24 years, mean ~ 4 (SD 3.1) hospitalisations, BPRS mean ~ 27 (SD 6.4), GAS mean 55 (SD 10.4), daily neuroleptic dose mean ~ 470 mg CPZ (SD 680)

Interventions 1. Psychoeducational medication training (PT) + leisure time group (LTG) at 7 study centres: 10 sessions in groups of 4-6 patients with one or two psychotherapists during 15 weeks. First 5 sessions once a week, next ﬁve twice a fortnight. n = 32. 2. PT + key person counselling 10 sessions (KC) + LTG. n = 35. 3. PT + cognitive psychotherapy (CP). n = 34. 4. PT + KC + CP. n = 33. 5. Control group patients attended a structured but unspeciﬁc leisure-time group of same length. n = 57

Outcomes Relapse. Global state: GAS. Unable to use - Medication compliance (no usable data). Mental state: BPRS (no usable data). Qualiﬁcation for medication self-management (no usable data). Illness-related attitudes: KK-Skala (no usable data). Satisfaction with knowledge (no usable data).

Notes *n = 44 patients dropped out before start of intervention and were not included in the data reporting and analysis of the original study, so we could not make “lost binary data” assumptions

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Randomised by independent third party, in bias) which age, sex, prognosis and medication compliance were balanced by preliminary matching. Randomisation by an independent institution, ZMBT

Allocation concealment (selection bias) Unclear risk Unclear.

Blinding of participants and personnel High risk Blind rating for readmission (independent (performance bias) criterion as researchers had no inﬂuence on All outcomes this). Relapse data, compliance data and other outcomes where not blindly rated

Blinding of outcome assessment (detection High risk Blind rating for readmission (independent bias) criterion as researchers had no inﬂuence on All outcomes this). Relapse data, compliance data and other outcomes where not blindly rated

Incomplete outcome data (attrition bias) High risk n = 44 patients dropped out before start of All outcomes intervention and were not included in analysis but compared on socio-demographic and other characteristics to trial group

Selective reporting (reporting bias) Low risk All measured outcomes reported.

Other bias Low risk None obvious.

Group - Li 2003

Methods Allocation: randomised - no further description. Blindness: not stated. Duration: 6 months. Setting: ChuXiongZhou Psychiatric Hospital, YunNan Province, China

Participants Diagnosis: schizophrenia (CCMD-2-R). n = 120. Age: average age ~ 37 (SD ~ 10). Sex: male and female. History: average length of illness ~ 13 years (SD ~ 9). Inclusion: not stated.

Interventions 1. Family intervention (psychoeducation): introduce to patients and family basic information about schizophrenia, its treatment and rehabilitation, adverse effects of medication & importance of continuous treatment; guidance on communication & social skills; 1/month for 6 months. n = 68 2. Routine care. n = 52.

Outcomes Mental state: BPRS. Unable to use -: Mental state: BPRS sub-scale scores. Behavioural outcome - level of symptoms: SCL-90 sub-scale scores

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomised, but no randomisation detail bias) described.

Allocation concealment (selection bias) Unclear risk Not described.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) High risk Those leaving early were excluded from the All outcomes analysis

Selective reporting (reporting bias) Low risk All measured outcomes were reported.

Other bias Low risk None obvious.

Group - Lv 2007

Methods Allocation: randomised - by tossing a coin. Blinding: not stated. Duration: 8 weeks + 9 months. Setting: inpatient, Jinhua Number 2 Hospital, Zhejiang, China

Participants Diagnosis: schizophrenia. n = 62. Age: mean ~ 35 years, SD ~ 6 years. Sex: male and female. History: not stated. Exclusion: severe physical illness.

Interventions 1. Psychoeducation: background knowledge on schizophrenia; importance of family environment; role of family members; group therapy, one session/week. n = 30 2. Routine care. n = 30.

Outcomes Quality of life: FAD, GQOLI-74.

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Randomised by tossing a coin. bias)

Allocation concealment (selection bias) Unclear risk Not stated.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) Low risk No incomplete data. All outcomes

Selective reporting (reporting bias) Low risk All measured outcomes reported.

Other bias Low risk None obvious.

Group - Merinder 1999

Methods Allocation: stratiﬁed for gender and for illness duration, randomisation carried out by an independent institution. Blinding: relapse and compliance assessed blindly. Duration: 8 weeks, 1 year follow-up. Setting: two community psychiatric centres in Aarhus and Viborg, Denmark

Participants Diagnosis: schizophrenia (F20.2-F20.9) ICD Danish version, OPCRIT. n = 46. Age: median 35.9 years, interquartile range 30.3 to 39.6 years. Sex: male and female. History: illness duration median 8.2 years, earlier admissions median 5. In treatment at 2 community psychiatric centres

Interventions 1. Psychoeducational sessions: 8 sessions, using didactic, interactive method standardised with manual for group leaders and booklet for participants; weekly group of 5 to 8 participants conducted separately for patients and relatives, n = 24 2. Standard care: psychopharmacological treatment, psychosocial rehabilitation efforts and some supportive psychotherapy, n = 22

Outcomes Compliance: non-compliance episodes of 14 days. Relapse. Mental state: BPRS. Global state: GAF. Satisfaction: VSSS. Expressed emotion: FQ. Unable to use -

Knowledge: (instrument non-validated). Insight: IS (instrument non-validated).

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Randomisation carried out by an indepen- bias) dent institution.

Allocation concealment (selection bias) Low risk Patients included before randomisation, given participant numbers, separated from patient identiﬁcation data. Allocation of patent-numbers to intervention/control done subsequently.

Blinding of participants and personnel Low risk Single blind (assessor blind). (performance bias) All outcomes

Blinding of outcome assessment (detection Low risk Single blind (assessor blind). bias) All outcomes

Incomplete outcome data (attrition bias) Low risk ITT used. All outcomes

Selective reporting (reporting bias) Low risk ITT used.

Other bias Unclear risk None obvious.

Group - Razali 1995

Methods Allocation: random. Blinding: not reported. Duration: one session and follow-up 1 year. Setting: Malaysia.

Participants Diagnosis: schizophrenic disorder (DSM-III-R). n = 165. Age: < 15 years 6 patients and > 60 years 2 patients, most between 20-30. Sex: M 69, F 96. History: all poor compliance, 46 patients had depot injection, 30% treated with chlor- promazine, haloperidol or triﬂuoperazine, 30% chronic

Interventions 1. Counseling session: by trained hospital pharmacist at discharge in presence of key relative; frequency of drug dosage was reduced to twice a day. n = 85 2. No counselling: also received routine prescription of medication. n = 80

Outcomes Relapse.

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomisation method not stated. bias)

Allocation concealment (selection bias) Unclear risk Not stated.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) Unclear risk Not stated concerning total dropout and All outcomes ITT (intention-to treat-criteria fulﬁlled)

Selective reporting (reporting bias) Low risk Only compliance and readmission measured and reported.

Other bias High risk Control patients were not given as much therapist time.

Group - Zhang 2006

Methods Allocation: randomised - no further description. Blinding: not stated. Duration: 8 weeks. Setting: Mental Health Centre of Shantou University, Guangdong, China

Participants Diagnosis: schizophrenia (CCMD-3). n = 60. Age: not stated. Sex: not stated. History: not stated. Exclusion: severe physical or other mental illness, drug/alcohol dependent

Interventions 1. Psychoeducation + standard drug therapy: provide patients with information on cause, development & symptoms of illness, crisis strategy, communication with family member, maintain medication; 30 minutes/session, 1 session/week. n = 30 2. Standard drug therapy. n = 30.

Outcomes Compliance with medication. Mental state: BPRS score.

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomisation method not stated. bias)

Allocation concealment (selection bias) Unclear risk Not stated.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) Low risk No incomplete outcome data. All outcomes

Selective reporting (reporting bias) Low risk All measured outcomes reported.

Other bias Low risk None obvious.

Individual - Cunningham 2001

Methods Allocation: randomised. Blindness: none. Duration: 12 months (intervention: 1, 15-minute session). Setting: 11 Hospitals, Scotland.

Participants Diagnosis: schizophrenia (DSM-III-R). n = 114. Age: 16 - 64 [mean age: control group, 33.6 (10.8), intervention group 36.8 (10.4)] Sex: M 81 and F 33. History: psychiatric history and current medication information. Included: DSM-III-R diagnosis of schizophrenia, at least one episode of schizophrenia, aged 16-64, due for discharge from inpatient or day patient care, recommendation for

maintenance antipsychotic medication from responsible consultant, informal legal status Exclusion: patients on clozapine or lithium.

Interventions 1. Education intervention: 15 minute video, 3 booklets containing information from the video, 15-minute educational video and three differently presented booklets about improve understanding of illness and acceptance of medication; enhance factual knowledge and correct erroneous, insight-related misconceptions about the disorder, the risks of relapse, consequences of symptom exacerbation; address the question of stigma, nature and treatment of side effects. n = 61 2. Standard care: routine clinical practice - participants were seen by the research psychiatrist and having the same standardised mental state assessments conducted; treated as in routine clinical practice n = 53

Outcomes Relapse. Medication side effects: TAKE, AIMS, the Barnes akathisia scale, UKU side effect rating scale Mental state: PANSS, MADRS. Knowledge: ITAQ. Unable to use - PANSS: no useable data reported.

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Following initial assessment, participants bias) were allocated by means of random numbers in sealed envelopes to either intervention or control group

Allocation concealment (selection bias) Low risk Randomszation was conducted at the trial centre and was remote from the assessors

Blinding of participants and personnel Unclear risk Patients were followed up by a research psy- (performance bias) chiatrist who was not blind to group status All outcomes

Blinding of outcome assessment (detection Unclear risk No reported bias) All outcomes

Incomplete outcome data (attrition bias) Unclear risk No information given on why participants All outcomes dropped out. Quote:” Nine patients in the intervention group (14.8%) and nine in the control group (17.0%) dropped out pre- maturely”. High number of relapse rate in the study. Quote “Over the 12 months of

follow-up, 22 (36.1%) of the intervention group and 22 (41.5%) of the control group relapsed”. Exclusions not clearly reported for some outcome data. Quote: “Such data were only available on the 46 subjects who had neither relapsed nor dropped-out”

Selective reporting (reporting bias) Unclear risk All outcome data are reported but lack of clarity on some main outcomes, such as PANSS no means or SD reported. Lack of clarity on dropouts and relapse rates at every follow-up stage

Other bias Low risk Funding: funded by the Medical Research Council of Great Britain

Individual - Macpherson 1996

Methods Allocation: random - a random numbers table. Blinding: all ratings were carried out by the author, without blinding procedures. Duration: 7 weeks. Setting: UK.

Participants Diagnosis: schizophrenia (DSM-III-R). n = 67. Age: mean 45.2 years, SD ~ 13 years. Sex: M 48, F 16. History: largely (54/64) community based, chronic, institutionalised population, at least 6 months cumulative antipsychotic drug exposure and clinical stability. Years in institution mean 12.8 (SD 11.8). Education mean 11 y (SD 1.9).

Interventions 1. Single individualised educational session: followed manual guidelines based on psychoeducation literature & principles of general health education. n = 24 2. Individualised teaching: in 3 education sessions 25-35 minutes/session at weekly interval. n = 23 3. No education. n = 20.

Outcomes Compliance: SAI - compliance sub-scale. Knowledge change: UMQ. Unable to use - Mental state (no usable data).

Notes All education was performed by the author RM.

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Using a random numbers table bias)

Allocation concealment (selection bias) Unclear risk Not stated.

Blinding of participants and personnel High risk Open label (performance bias) All outcomes

Blinding of outcome assessment (detection High risk Open label bias) All outcomes

Incomplete outcome data (attrition bias) Low risk No incomplete data. All outcomes

Selective reporting (reporting bias) Low risk All measured outcomes reported.

Other bias Low risk None obvious.

Individual - Nasr 2009

Methods Allocation: randomised. Blindness: researcher blind. Duration: 6 months post intervention (intervention: 9 sessions over 6 months) Setting: outpatient department, Lahore, Pakistan.

Participants Diagnosis: schizophrenia (DSM-IV TR). n = 108. Age: 18-45 (mean age: control group, 27.00 (7.29), intervention group 25.31 (7.02)) Sex: M 58, F 50. History: age at onset, number of admissions in hospital, number of relapses, family history of mental illness. Included: aged between 18-45 years, history of two or more relapses during the course of their illness despite getting treatment Exclusion: patients manifesting schizophrenia-like symptoms due to any organic disorder such as dementia or any other cognitive impairment, abuse of alcohol or of drugs acting on the central nervous system and those with clinical evidence of epilepsy or intellectual disability

Interventions 1. Psychoeducation + psychotropic drugs; for families and patients - content: general information about schizophrenia, its nature, types and causes; schizophrenia affecting on thoughts, emotions and behaviour; importance of pharmacological treatment; general advice encouraging family members to address their personal and social needs; following ﬁve sessions were discussion about the problems,when the patient was in a stable phase, they will be educated on the nature and process of illness and compliance with pharmacological treatment, n = 52 2. Psychotropic drugs, n = 56.

Outcomes Relapse. Death. Unable to use - Number of relapses: no data scores mentioned Family burden (FBIS): skewed data

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Random allocation done independently. bias) Quote: “Patients with schizophrenia were randomly allocated to one of two groups, a psychoeducation group or a non-psychoeducation group” (p5)

Allocation concealment (selection bias) Low risk An independent controlled randomly allocated the individuals to either the psychoeducation or control group. Quote: “The researcher was not involved in the randomisation of the patients and families, which was performed at the institution.”

Blinding of participants and personnel Unclear risk No blinding information given on patients (performance bias) and families, the researcher was not in- All outcomes volved in randomisation but no clear information whether they were blinded

Blinding of outcome assessment (detection Unclear risk As above. bias) All outcomes

Incomplete outcome data (attrition bias) High risk n = 8 individuals were lost at follow-up. All outcomes Only addressed: one died (psycho-education group). No mention of the n = 7 that were dropped/lost at the follow-up stage and from which group. No mention of whether they were excluded from the analysis

Selective reporting (reporting bias) Unclear risk Number of relapses was collected but not reported in the paper. Quote: “The questionnaire was designed to collect information about age, sex, educational level, birth order, number of siblings, marital status, number of children, occupation and work

status, and to gather details about the illness (age at onset, number of admissions in hospital, number of relapses, family history of mental illness and so on). Information on age, sex, educational level, number of siblings, marital status, number of children, occupation and work status is reported.”

Other bias Unclear risk Funding not stated.

Unclear - Li 2005

Methods Allocation: randomised. Blinding: not stated. Duration: 8 weeks intervention + 3 months follow-up. Setting: Kangning Hospital, Shenzhen City, China.

Participants Diagnosis: schizophrenia (CCMD-3-R). n = 286. Age: mean ~ 32.5 years, SD ~ 17.2 years. Sex: male and female. History: < 10 years. Exclusion: with combined other mental health problem, or if their conditions are obvi- ously deteriorating

Interventions 1. Psychoeducation: introduce patients to i. background of prescribed medication; ii. importance of taking medication; iii. review on beneﬁt of medication; iv. discussion on schizophrenia as an illness; v. medication management after discharge; frequency 1/week. n = 143 2. Routine health education:provided as a part of standard care. n = 143

Outcomes Compliance: with medication and follow up (leaving the study early) Unable to use - Compliance: with medication continuous data - derived from unpublished scale

Notes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomisation method not stated. bias)

Allocation concealment (selection bias) Unclear risk Not stated.

Blinding of participants and personnel Unclear risk Not stated. (performance bias) All outcomes

Blinding of outcome assessment (detection Unclear risk Not stated. bias) All outcomes

Incomplete outcome data (attrition bias) High risk Those leaving early were excluded from the All outcomes analysis.

Selective reporting (reporting bias) Low risk All measured outcomes reported.

Other bias Low risk None obvious.

Diagnosis CCMD-3 = Chinese Classiﬁcation of Mental Disorders Version 3 DSM-III = Diagnostic and Statistical Manual of Mental disorders, third edition DSM-IV = Diagnostic and Statistical Manual of Mental disorders, fourth edition ICD = International Classiﬁcation of Diseases Mental state: BDI = Beck Depression Inventory BPRS = Brief Psychiatric Rating Scale GWB = General Well-being Schedule MADRS = Montgomery-Åsberg Depression Rating Scale PANSS = Positive and Negative Syndrome Scale SANS = Scale for the Assessment of Negative Symptoms SAPS = Scale for the Assessment of Positive Symptoms SAS = Zung Self-Rating Anxiety Scale SDS = Zung Self-Rating Depression Scale SES = Rosenberg Self-esteem Scale Social functioning MRSS = Morningside Rehabilitation Status Scale NOSIE = Nurses’ Observation Scale for InPatient Evaluation SDSS = Social Disability Screening Schedule Global state GAF = Global Assessment of Functioning GAS = Global Assessment Scale Satisfaction with care CSQ = Client Satisfaction Questionnaire-8 VSSS = Verona Service Satisfaction Scale Quality of life FAD = Family Assessment Device FBIS = Family Burden Interview Schedule MSQoL = Modular System of Quality of Life-54 SF-36 = Short Form 36 GQOLI-74 = General Quality of Life Inventory-74 Knowledge

Psychoeducation (brief) for people with serious mental illness (Review) 67 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. FQ = Family Questionnaire ITAQ = Insight Treatment Attitude Questionnaire KASI = Knowledge About Schizophrenia Inventory KSQ = Knowledge of Schizophrenia Questionnaire OMI = Opinions About Mental Illness SAUMD = Scale to Assess Unawareness of Mental Disorder UMQ = Understanding of medication questionnaire Miscellaneous CBT = cognitive behavioural therapy ITT = intention-to-treat SD = standard deviation

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Carra 2010 Allocation: randomised. Patients: schizophrenia Intervention: 24 sessions of informative programme versus 24 sessions of informative programme plus 48 sessions of supportive group programme

Chabannes 2009 Allocation: randomised. Patients: schizophrenia. Intervention: 21 sessions of psychoeducational programme versus 21sessions of programme delivering usual information on the disease

Cheng 2005 Allocation: randomised. Patients: schizophrenia, however, the participants were only family members of the patients Intervention: 10 weekly psychoeducation sessions based on the routine care versus routine care

Chien 2013 Allocation: randomised. Patients: schizophrenia. Intervention: 24-week psychoeducation programme contains elements of interpersonal skills training versus 24-week mutual support group versus standard care

Fries 2003 Allocation: randomised controlled trial. Patients: schizophrenic and schizoaffective disorders. Intervention: psychoeducative coping oriented therapy versus supportive discussion and problem-solving training

Hamann 2006 Allocation: randomised. Patients: schizophrenia. Intervention: the ’decision aid’ intervention employed in this trial simply provides information about the illness, but it lacks of core elements of psychoeducation; the control group was routine care

Magliano 2004 Allocation:randomised. Patients: Participants are families of patients with schizophrenia. Intervention: psychoeducation family intervention versus routine care

McFarlane 1995 Allocation: randomised Patients: schizophrenia, schizoaffective disorder, or schizophreniform disorders Intervention: assertive community treatment combined with psychoeducational multifamily treatment group versus assertive community treatment combined with crisis family intervention; psychoeducation is given only as one element of a care package, which includes other elements such as skills training and family support

O’Callaghan 2009 Allocation: randomised. Patients: schizophrenia. Intervention: psychoeducation for cares, rather than for patients; psychoeducation versus non speciﬁc group for carers or treatment as usual

Pfammatter 1999 Allocation: randomised Patients: people with schizophrenic and schizoaffective disorders Intervention: coping oriented therapy, not psychoeducation, no more details

Pitschel-Walz 2013 Allocation:randomised. Patients: schizophrenia. Intervention: cognitive training versus occupational therapy

Posner 1992 Allocation: randomised. Patients: schizophrenia. Intervention: Each patient was asked to name an individual family member with whom he or she has the closest contact, the family members participated in this trial and were randomly assigned to either the psychoeducational support-group or wait-list group

Ran 2003 Allocation: cluster randomised trial. Participants: people with schizophrenia, their families did not attend this trial Intervention: participants were randomly assigned to three groups: i) drug treatment plus psychoeducational family intervention; ii) drug treatment only or iii) no interventions which means medications were not neither encouraged or discouraged

Rotondi 2005 Allocation: randomised. Participants: people with schizophrenia or schizoaffective disorder Intervention: Telehealth Intervention group includes: three online therapy groups:family members/support persons only (FTG), (b) persons with schizophrenia only (PWSTG), and (c) multifamily therapy group for all intervention participants (MFTG); participants in the control group received usual care

Schlosser 2012 Allocation: not randomised.

Shin 2002 Allocation: randomised Participants: people with schizophrenia Intervention: standard length psychoeducation (10 sessions) vs supportive therapy

Sibitz 2007 Allocation: randomised Participants: people with schizophrenia or schizoaffective disorder Intervention: patients received 9 weeks of psychoeducation before they were randomised to receive 9 months of booster sessions on a monthly basis. Essentially, the intervention is booster sessions vs no booster sessions

Xiang 1994 Allocation: randomised Patients: people with schizophrenia and their family members Intervention: drug treatment plus psychoeducational family intervention versus drug treatment only; however, only family members of received the psychoeducation; all patients received drug therapy

Ying 2006 Allocation: randomised. Patients: people with schizophrenia and their family members Intervention: psychoeducational family intervention plus drug therapy versus drug therapy alone; psychoeducation included crisis intervention and predominantly to educate family members of the knowledge of schizophrenia and its treatment and rehabilitation

Characteristics of studies awaiting assessment [ordered by study ID]

Bechdolf 2000

Methods See notes below

Participants

Interventions

Outcomes

Notes Foreign language paper, awaiting translation.

Cormier 1995

Methods Allocation: randomised. Blindness: not stated. Duration: 2 years (intervention 10 sessions over 20 weeks).

Participants Diagnosis: schizophrenia n = 95 Age: not stated Sex: not stated History: not stated Included: not stated Exclusion: not stated

Interventions 1. Psychoeducation (n = 29). 2. Leisure activates (n = 26). 3. Usual care, support therapy with their psychiatrist (n = 40)

Outcomes None listed.

Notes Conference abstract only; no data available - more information needed

Methods Allocation: unclear

Participants Diagonosis:Schizophrenia

Interventions 1.Psychoeducational group 2.Control group

Outcomes Readmission rates

Notes Full text is foreign language

Hahlweg 1997

Methods See notes below

Participants

Interventions

Outcomes

Notes German language article - awaiting classiﬁcation.

Hornung 1998a

Methods Allocation: unclear

Participants Diagnosis: schizophrenia n = 131

Interventions 1. Psychoeducation (10 sessions) 2. Control group

Outcomes Compliance Knoledge about medication Conﬁdence in medication

Notes Paper in German - awaiting translation.

Kissling 2007

Methods Allocation: randomised Location: Germany

Participants Diagnosis:Schizophrenia or schizoaffective disorder, n = 896 Inclusion criteria: Schizophrenia or schizoaffective disorder (ICD-10); age 18 to 67 years; hospitalised or treated in a day care clinic Exclusion criteria: More than 12 months of hospitalisation within the last two years; substance-dependency (principal

diagnosis); mental retardation ICD-10; ﬂuency of German language

Interventions 1. Psychoeducation by professionals 2. Psychoeducation by peer-moderators 3. Video-education

Outcomes Rehospitalisation rate2. Rehospitalisation days Resulting costs per patient Cost-beneﬁt-analysis of the different interventions Compliance Compliance self-assessment (MARS/ DAI) Knowledge of illness Attitude towards illness Quality of life ( WHOQOL-BREF) Satisfaction questionnaire (ZUF-8) Duration of consultation time Dealing with mental illness (FMQ,BDI)

Notes Funded by Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany) (grant ref: 01GL0509), no access to the study result. Contacted author and awaiting for full text PDF

Lacruz 1999

Methods Allocation: randomly assigned

Participants Diagnosis: Schizophrenic patients and their key relatives n = 70

Interventions 1.Family intervention programmes with fundamental component of educational module 2.A different family intervention

Outcomes KASI

Notes Full text is in foreign language, awaiting for translation.

Mihai 2005

Methods Allocation: randomised

Participants Diagnosis: schizophrenia. n = 60 Inclusion: Aged 18-60 years; Hospitalised in the Psychiatric Clinic II Tg. Mures, Romania Exclusion: Schizophrenia and affective disorder

Interventions 1. Mediacation with psychoeducation, n = 30. 2. Medication only, n = 30.

Outcomes BPRS CGI Qustionare about attitude and compliance

Notes Abstract: no contact information

Motlova 2002

Methods Unknown.

Participants

Interventions

Outcomes

Notes We only have the title of this study, which seems relevant to this review. However, we are still seeking for the full text publication

Nischk 2011

Methods Allocation: randomly assigned

Participants Diagonosis: acute psychotic patients diagnosed by ICD-10 F2 n = 57.

Interventions 1.Brief psychoeducation and treatment as usual 2.Treatment as usual

Outcomes Knowledge gain Insight Illness perception

Notes Full text is in foreign language, awaiting for translation.

Pitschel-Walz 1993

Methods Unknown.

Participants

Interventions

Outcomes

Notes We only have the title of this study, which seems relevant to this review. However, we are still seeking for the full text publication

Methods Unknown.

Participants

Interventions

Outcomes

Notes We only have the title of this study, which seems relevant to this review. However, we are still seeking for the full text publication

Poplawska 2004

Methods Allocation: randomly assigned Location: Department of Psychiatry of Medical Academy in Bialystok

Participants Diagnosis: schizophrenic and depressive patients n = 52

Interventions 1.Medication and psychoeducation 2.Medication without psychoeducation

Outcomes BPRS BNS IMHC 2000 Raskin/Covi Scale DAI-10

Notes Full text is in foreign language, awaiting for translation.

Schonell 1995

Methods Allocation: randomised controlled study.

Participants Diagnosis: schizophrenic/schizophreniform disorder n = 54

Interventions 1. Psycoeducational training on patients knowledge about their illness, twice a week for one hour over a period of four weeks 2. Training of social competence, twice a week for one hour over a period of four weeks

Outcomes Knowledge questionnaire

Notes Only abstract is available, awaiting for full text.

Methods Allocation: randomised controlled study. Location: Acute care unit of Psyne Whitney Clinic.

Participants Diagnosis: schizophrenic/schizophreniform disorder, schizophrenic,major affective disorder, other DSM-III axis I diagnoses n = 186 Inclusion criteria: no further information Exclusion criteria: no further information. Dropouts: 13 family treatment and 4 comparison were dropped from the study because their stays in the hospital were too short, at 6-month follow-up, 168 patients completed the treatment

Interventions 1.Standard hospital treatment + Family intervention (education the nature of illness and its treatment) 2.Standard hospital treatment

Outcomes GAS Clinical signiﬁcance( deﬁned by GAS scores two or more standard deviations above the pretreatment mean) Role Performance Treatment Scale (assesses patient level of functioning, interrater reliability was tested)

Notes Supported in part by biomedical research support grant RR-05396 from the National Institutes of Health to Cornell University Medical Centre Data (at 6 months and 18 months) are also not available Reason for awaiting for assessment is that the paper described the family intervention as a ’brief psychoeducational and problem-focused intervention’, but without further description on the detail and length or frequency of the intervention. We are currently trying to contact the author for clariﬁcation

Tarrier 2000

Methods Randomised controlled trial

Participants Patients with 2-year history of schizophrenia and their families

Interventions No information

Outcomes Patient - Clinical and symptom variables Needs assessment Carer - Psychological morbidity Need assessment service use Economic analysis

Notes Registered trial Contact author Tarrier Telephone: 0161 291 4431 Fax: 0161 291 3814 E-mail: [email protected]

Methods Allocation: randomly assigned

Participants Diagonosis: schizophrenia or schizoaffective disorder (diagnosed by DSM-IV)

Interventions 1. Community Re-Entry Program (CREP) (n = 47) 2. A standard series of Illness Education Classes (n = 47)

Outcomes Knowledge of Illness pertinent issues

Notes This is suspected to be the same study as Wirshing 2002. Although the N numbers in each treatment arm differs in the two trials, the results reported in the abstracts are the same. We are currently trying to contact author to obtain full text of both publications and for clariﬁcation on their associations

Wirshing 2002

Methods Allocation: randomly assigned

Participants Diagonosis: schizophrenia or schizoaffective disorder (diagnosed by DSM-IV)

Interventions 1. Community Re-Entry Program (CREP) (n = 39) 2. A standard series of Illness Education Classes(n = 41)

Outcomes Wisconsin Card Sorting Test California Verbal Learning Test Continuous Performance Task Digit Span Distractibility Test BPRS Schedule of Assessment for Negative Symptoms Global Assessment of Functioning

Notes This is suspected to be the same study as Wirshing 2000. Although the N numbers in each treatment arm differs in the two trials, the results reported in the abstracts are the same. We are currently trying to contact author to obtain full text of both publications and for clariﬁcation on their associations

BDI = Beck Depression Inventory BPRS = Brief Psychiatric Rating Scale BNS = Brief Negative Scale

DAI = Drug Attitude Inventory DSM = Diagnostic and Statistical Manual of Mental Disorders DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, fourth edition

FMQ = Mantonakis, Family Member Questionnaire

GAS = Global Assessment Scale

ICD = International Classiﬁcation of Diseases IMHC 2000 = International Mental Health Counselor 2000

Psychoeducation (brief) for people with serious mental illness (Review) 76 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. KASI = Knowledge About Schizophrenia Inventory

MARS = Medication Adherence Rating Scale

PANSS = Positive and Negative Syndrome Scale

WHOQOL = World Health Organisation Quality Of Life

Comparison 1. ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Compliance: 1a. With 4 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only medication - non-compliance 1.1 short term 3 448 Risk Ratio (M-H, Fixed, 95% CI) 0.63 [0.41, 0.96] 1.2 medium term 1 118 Risk Ratio (M-H, Fixed, 95% CI) 0.17 [0.05, 0.54] 2 Compliance: 1b. With 1 118 Risk Ratio (M-H, Fixed, 95% CI) 0.68 [0.39, 1.18] medication - partial compliance (medium term) 3 Compliance: 1c. With Other data No numeric data medication - average compliance with medication(data skewed) 3.1 single session - average Other data No numeric data compliance with medication (SAI sub-scale endpoint score, high = good) 3.2 three sessions - average Other data No numeric data compliance with medication (SAI sub-scale endpoint score, high = good) 4 Compliance: 1d. With 1 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only medication - very good/ good compliance (numberic compliance scale) 4.1 Medium term 1 236 Risk Ratio (M-H, Fixed, 95% CI) 1.05 [0.93, 1.18] 4.2 long term - 1 years 1 236 Risk Ratio (M-H, Fixed, 95% CI) 1.39 [1.16, 1.66] 4.3 long term - 2 years 1 236 Risk Ratio (M-H, Fixed, 95% CI) 1.46 [1.20, 1.76] 5 Compliance: 2a. With follow-up 8 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only - loss to follow-up for any reason 5.1 short term - loss to 1 30 Risk Ratio (M-H, Fixed, 95% CI) 1.0 [0.24, 4.18] follow-up for any reason 5.2 short term- received 1 67 Risk Ratio (M-H, Fixed, 95% CI) 3.06 [0.17, 56.70] intervention but left the study early 5.3 medium term - loss to 4 322 Risk Ratio (M-H, Fixed, 95% CI) 0.74 [0.50, 1.09] follow-up for any reason 5.4 long term - loss to 2 386 Risk Ratio (M-H, Fixed, 95% CI) 1.19 [0.83, 1.72] follow-up for any reason (by 1 year) 5.5 long term - loss to 2 387 Risk Ratio (M-H, Fixed, 95% CI) 0.83 [0.62, 1.11] follow-up for any reason (by 2 years)

Psychoeducation (brief) for people with serious mental illness (Review) 78 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 5.6 long term - loss to 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.73 [0.44, 1.21] follow-up for any reason (by 5 years or more) 5.7 long term- received 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.58 [0.33, 1.01] intervention but left the study early 6 Relapse: 1. Relapse for any 5 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only reason 6.1 medium term 4 406 Risk Ratio (M-H, Fixed, 95% CI) 0.70 [0.52, 0.93] 6.2 long term 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.85 [0.59, 1.22] 6.3 long term (at 5 years 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.89 [0.73, 1.08] follow-up) 7 Relapse: 2. Relapse with 1 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only readmission 7.1 medium term 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.85 [0.59, 1.22] 7.2 long term 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.83 [0.64, 1.08] 8 Knowledge: 1a. Average 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only endpoint scale scores on various knowledge scales 8.1 short term (ITAQ/KSQ, 2 97 Mean Difference (IV, Fixed, 95% CI) 7.39 [4.94, 9.83] high = favourable) 8.2 medium term (ITAQ, 1 73 Mean Difference (IV, Fixed, 95% CI) 4.83 [1.51, 8.15] high = favourable) 9 Knowledge: 1b. Average change Other data No numeric data (UMQ, high = good, data skewed) 9.1 single session Other data No numeric data psychoeducation 9.2 three session Other data No numeric data psychoeducation 10 Knowledge: 1c. Average Other data No numeric data endpoint (ITAQ, high = good, data skewed) (short term) 11 Knowledge: 2. Average 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected endpoint scores (SAUMD, high = poor) (short term) 12 Global state: 2. Average 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only endpoint scale score 12.1 short term (GAF/GAS, 1 41 Mean Difference (IV, Fixed, 95% CI) -2.64 [-12.74, 7.46] high = good) 12.2 medium term 2 101 Mean Difference (IV, Fixed, 95% CI) -0.50 [-5.48, 4.47] (GAF/GAS, high = good) 12.3 long term at 2 years(GAS, 1 59 Mean Difference (IV, Fixed, 95% CI) -6.70 [-13.38, -0.02] high = good) 12.4 long term at 5 years or 1 60 Mean Difference (IV, Fixed, 95% CI) -3.80 [-8.04, 0.44] more (GAS, high = good) 13 Service utilisation: 2 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only rehospitalisation 13.1 medium term 2 188 Risk Ratio (M-H, Fixed, 95% CI) 0.88 [0.43, 1.79] 13.2 long term 1 141 Risk Ratio (M-H, Fixed, 95% CI) 0.22 [0.05, 1.00]

Psychoeducation (brief) for people with serious mental illness (Review) 79 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 14 Mental state: 1a. Global - 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only average total endpoint scale scores (BPRS, high = poor) 14.1 short term 1 60 Mean Difference (IV, Fixed, 95% CI) -2.70 [-4.84, -0.56] 14.2 medium term 1 120 Mean Difference (IV, Fixed, 95% CI) -5.36 [-6.77, -3.95] 15 Mental state: 1b. Global - 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected average change scale scores (GWB/SES, high = good) (medium term) 15.1 General Well-being 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] Schedule(GWB) 15.2 Rosenberg Self-esteem 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] Scale (SES) 16 Mental state: 1c. Global - Other data No numeric data average total endpoint scale scores (BPRS, high = poor, data skewed) 16.1 short term Other data No numeric data 16.2 medium term Other data No numeric data 16.3 long term Other data No numeric data 17 Mental state: 2a. Specific 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected symptoms - short term 17.1 anxiety 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0] 17.2 depression 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0] 18 Mental state: 2b. specific 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected symptoms - average total endpoint scale score (high = poor) (short term) 18.1 anxiety-SAS 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 18.2 depression-SDS 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 19 Mental state: 2c. Specific Other data No numeric data symptoms - average total endpoint scale scores (MADRS, high = poor, data skewed) (short term) 20 Social functioning: 1a. Average 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected change scores on various scales (high = poor) (medium term) 20.1 MRSS 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 20.2 SDSS 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 21 Expressed emotion: Participants 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected with high EE relatives (FQ) 21.1 short term - at end of 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0] interventions 21.2 medium term 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0] 22 Expressed emotion for relatives: 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected Average change scores on FQ scales (high = good) 23 Quality of life: 1a. Average 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected endpoint scores (GQOLI-74, high = good) 23.1 short term 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]

Psychoeducation (brief) for people with serious mental illness (Review) 80 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 23.2 medium term 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 24 Quality of life: 1b. Average 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected endpoint scores (FAD, high = poor) 24.1 short term 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 24.2 medium term 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 25 Quality of life: 1c. Average Other data No numeric data endpoint scores (FBIS, high = poor, data skewed) 25.1 Financial Other data No numeric data 25.2 Routine Other data No numeric data 25.3 Leisure Other data No numeric data 25.4 Interaction Other data No numeric data 25.5 Physical health Other data No numeric data 25.6 Psychological health Other data No numeric data 26 Satisfaction with mental health 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected services: 1. Average change score (VSS, high = good) (short term) 26.1 patients’ satisfaction 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 26.2 relatives’ satisfaction 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 27 Satisfaction with mental health 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected services: 2. Average change (VSS Scale, high = good) (long term at 1 year) 27.1 patients’ satisfaction with 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] relatives’ involvement - mean change 27.2 relatives’ involvement 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] satisfaction 27.3 relatives’ efﬁcacy 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] satisfaction 27.4 relatives’ intervention 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] satisfaction 28 Patients’ satisfaction with 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected mental health services: average endpoint scores (CSQ, high = good) (short term) 29 Adverse event: Death 3 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only 29.1 medium term 2 154 Risk Ratio (M-H, Fixed, 95% CI) 0.99 [0.15, 6.65] 29.2 long term 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.85 [0.05, 13.30]

Psychoeducation (brief) for people with serious mental illness (Review) 81 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Comparison 2. ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Compliance: With medication 1 Mean Difference (IV, Fixed, 95% CI) Subtotals only (numberic compliance scale, high = good) 1.1 short term 1 88 Mean Difference (IV, Fixed, 95% CI) -0.20 [-0.42, 0.02] 1.2 medium term 1 88 Mean Difference (IV, Fixed, 95% CI) -0.30 [-0.70, 0.10] 1.3 long term 1 41 Mean Difference (IV, Fixed, 95% CI) -0.5 [-1.05, 0.05] 2 Relapse: Relapse for any reason 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected (medium term) 3 Service utilisation: 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected hospitalisation (long term) 4 Mental state: Speciﬁc - average 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected endpoint PANSS scores (high = poor) 4.1 short term - positive score 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 4.2 short term - negative score 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 4.3 short term - general score 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 4.4 medium term - positive 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] score 4.5 medium term - negative 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] score 4.6 medium term - general 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] score 4.7 long term - positive score 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 4.8 long term - negative score 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 4.9 long term - general score 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 5 Quality of life: Average endpoint 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected MSQoL-54 score (high = good) 5.1 short term 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 5.2 medium term 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]

Comparison 3. SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOE- DUCATION vs ROUTINE CARE/INFORMATION

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Compliance: 1a. With 4 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only medication - non-compliance 1.1 group - short term 2 162 Risk Ratio (M-H, Fixed, 95% CI) 0.5 [0.18, 1.40] 1.2 unclear - short term 1 286 Risk Ratio (M-H, Fixed, 95% CI) 0.67 [0.42, 1.06] 1.3 both - medium term 1 118 Risk Ratio (M-H, Fixed, 95% CI) 0.17 [0.05, 0.54]

Psychoeducation (brief) for people with serious mental illness (Review) 82 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 2 Compliance: 1b. With follow 7 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only up - loss to follow-up for any reason 2.1 both - short term - loss to 1 30 Risk Ratio (M-H, Fixed, 95% CI) 1.0 [0.24, 4.18] follow-up for any reason 2.2 group - medium term - 3 208 Risk Ratio (M-H, Fixed, 95% CI) 0.70 [0.45, 1.09] loss to follow-up for any reason 2.3 individual - medium term 1 114 Risk Ratio (M-H, Fixed, 95% CI) 0.87 [0.37, 2.03] - loss to follow-up for any reason 2.4 group - long term - loss to 2 386 Risk Ratio (M-H, Fixed, 95% CI) 1.19 [0.83, 1.72] follow-up for any reason (by 1 year) 2.5 group - long term - loss to 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.70 [0.43, 1.15] follow-up for any reason (by 2 years) 2.6 group - long term - loss to 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.73 [0.44, 1.21] follow-up for any reason (by 5 years or more) 3 Relapse: 1. Relapse for any 5 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only reason 3.1 group - medium term 3 292 Risk Ratio (M-H, Fixed, 95% CI) 0.61 [0.43, 0.89] 3.2 individual - medium term 1 114 Risk Ratio (M-H, Fixed, 95% CI) 0.87 [0.55, 1.38] 3.3 group - long term 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.85 [0.59, 1.22] 3.4 group - long term (at 5 1 124 Risk Ratio (M-H, Fixed, 95% CI) 0.89 [0.73, 1.08] years follow-up)

Comparison 4. SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDU- CATION vs CBT

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Relapse: Relapse for any reason 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected (medium term) 2 Relapse: Relapse for any reason 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected (medium term)-without assumption

Psychoeducation (brief) for people with serious mental illness (Review) 83 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Comparison 5. SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Compliance: 1a. With 3 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only medication - non-compliance 1.1 short term - with high risk 3 448 Risk Ratio (M-H, Fixed, 95% CI) 0.63 [0.41, 0.96] trials 1.2 short term - without high 1 60 Risk Ratio (M-H, Fixed, 95% CI) 0.67 [0.12, 3.71] risk trials

Analysis 1.1. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance.

Review: Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION

Outcome: 1 Compliance: 1a. With medication - non-compliance

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 short term Group - Dai 2007 3/51 7/51 15.2 % 0.43 [ 0.12, 1.57 ]

Group - Zhang 2006 2/30 3/30 6.5 % 0.67 [ 0.12, 3.71 ]

Unclear - Li 2005 24/143 36/143 78.3 % 0.67 [ 0.42, 1.06 ] Subtotal (95% CI) 224 224 100.0 % 0.63 [ 0.41, 0.96 ] Total events: 29 (Brief Psychoeducation), 46 (Routine care) Heterogeneity: Chi2 = 0.40, df = 2 (P = 0.82); I2 =0.0% Test for overall effect: Z = 2.15 (P = 0.032) 2 medium term Both - Liu 2004 3/59 18/59 100.0 % 0.17 [ 0.05, 0.54 ] Subtotal (95% CI) 59 59 100.0 % 0.17 [ 0.05, 0.54 ] Total events: 3 (Brief Psychoeducation), 18 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 3.01 (P = 0.0026) Test for subgroup differences: Chi2 = 4.41, df = 1 (P = 0.04), I2 =77%

0.02 0.1 1 10 50 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 84 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.2. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With medication - partial compliance (medium term).

Review: Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION

Outcome: 2 Compliance: 1b. With medication - partial compliance (medium term)

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Both - Liu 2004 15/59 22/59 100.0 % 0.68 [ 0.39, 1.18 ] Total (95% CI) 59 59 100.0 % 0.68 [ 0.39, 1.18 ] Total events: 15 (Brief Psychoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.37 (P = 0.17) Test for subgroup differences: Not applicable

0.2 0.5 1 2 5 Favours psychoeducation Favours routine care

Analysis 1.3. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 3 Compliance: 1c. With medication - average compliance with medication(data skewed). Compliance: 1c. With medication - average compliance with medication(data skewed)

Study Intervention Mean SD N single session - average compliance with medication (SAI sub-scale endpoint score, high = good)

Individual - Macpherson Psychoeducation 2.6 1.2 22 1996

Individual - Macpherson Routine care 2.1 1.3 20 1996 three sessions - average compliance with medication (SAI sub-scale endpoint score, high = good)

Individual - Macpherson Psychoeducation 2.18 1.3 22 1996

Individual - Macpherson Routine care 2.1 1.3 20 1996

Psychoeducation (brief) for people with serious mental illness (Review) 85 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.4. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 4 Compliance: 1d. With medication - very good/ good compliance (numberic compliance scale).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 4 Compliance: 1d. With medication - very good/ good compliance (numberic compliance scale)

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Medium term Group - Bauml 2007 106/125 90/111 100.0 % 1.05 [ 0.93, 1.18 ] Subtotal (95% CI) 125 111 100.0 % 1.05 [ 0.93, 1.18 ] Total events: 106 (Brief Psychoeducation), 90 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.75 (P = 0.45) 2 long term - 1 years Group - Bauml 2007 100/125 64/111 100.0 % 1.39 [ 1.16, 1.66 ] Subtotal (95% CI) 125 111 100.0 % 1.39 [ 1.16, 1.66 ] Total events: 100 (Brief Psychoeducation), 64 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 3.53 (P = 0.00042) 3 long term - 2 years Group - Bauml 2007 100/125 61/111 100.0 % 1.46 [ 1.20, 1.76 ] Subtotal (95% CI) 125 111 100.0 % 1.46 [ 1.20, 1.76 ] Total events: 100 (Brief Psychoeducation), 61 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 3.88 (P = 0.00011)

0.5 0.7 1 1.5 2 Favours routine care Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) 86 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.5. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 5 Compliance: 2a. With follow-up - loss to follow-up for any reason.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 5 Compliance: 2a. With follow-up - loss to follow-up for any reason

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 short term - loss to follow-up for any reason Both - Tom 1989 3/15 3/15 100.0 % 1.00 [ 0.24, 4.18 ] Subtotal (95% CI) 15 15 100.0 % 1.00 [ 0.24, 4.18 ] Total events: 3 (Brief Psychoeducation), 3 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.0 (P = 1.0) 2 short term- received intervention but left the study early Individual - Macpherson 1996 3/47 0/20 100.0 % 3.06 [ 0.17, 56.70 ] Subtotal (95% CI) 47 20 100.0 % 3.06 [ 0.17, 56.70 ] Total events: 3 (Brief Psychoeducation), 0 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.75 (P = 0.45) 3 medium term - loss to follow-up for any reason Group - Coyle 1988 4/17 1/21 2.0 % 4.94 [ 0.61, 40.19 ]

Group - Merinder 1999 6/24 9/22 21.5 % 0.61 [ 0.26, 1.44 ]

Individual - Cunningham 2001 9/61 9/53 22.0 % 0.87 [ 0.37, 2.03 ]

Group - Hornung 1995 15/67 22/57 54.4 % 0.58 [ 0.33, 1.01 ] Subtotal (95% CI) 169 153 100.0 % 0.74 [ 0.50, 1.09 ] Total events: 34 (Brief Psychoeducation), 41 (Routine care) Heterogeneity: Chi2 = 4.23, df = 3 (P = 0.24); I2 =29% Test for overall effect: Z = 1.51 (P = 0.13) 4 long term - loss to follow-up for any reason (by 1 year) Group - Aguglia 2007 6/75 9/75 22.7 % 0.67 [ 0.25, 1.78 ]

Group - Bauml 2007 44/125 29/111 77.3 % 1.35 [ 0.91, 2.00 ] Subtotal (95% CI) 200 186 100.0 % 1.19 [ 0.83, 1.72 ] Total events: 50 (Brief Psychoeducation), 38 (Routine care) Heterogeneity: Chi2 = 1.72, df = 1 (P = 0.19); I2 =42% Test for overall effect: Z = 0.95 (P = 0.34) 5 long term - loss to follow-up for any reason (by 2 years) Group - Hornung 1995 19/67 23/57 36.8 % 0.70 [ 0.43, 1.15 ]

Group - Bauml 2007 46/152 37/111 63.2 % 0.91 [ 0.64, 1.30 ]

0.002 0.1 1 10 500 Favours psychoeducation Favours routine care (Continued ... )

Psychoeducation (brief) for people with serious mental illness (Review) 87 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (... Continued) Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Subtotal (95% CI) 219 168 100.0 % 0.83 [ 0.62, 1.11 ] Total events: 65 (Brief Psychoeducation), 60 (Routine care) Heterogeneity: Chi2 = 0.68, df = 1 (P = 0.41); I2 =0.0% Test for overall effect: Z = 1.24 (P = 0.21) 6 long term - loss to follow-up for any reason (by 5 years or more) Group - Hornung 1995 19/67 22/57 100.0 % 0.73 [ 0.44, 1.21 ] Subtotal (95% CI) 67 57 100.0 % 0.73 [ 0.44, 1.21 ] Total events: 19 (Brief Psychoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.20 (P = 0.23) 7 long term- received intervention but left the study early Group - Hornung 1995 15/67 22/57 100.0 % 0.58 [ 0.33, 1.01 ] Subtotal (95% CI) 67 57 100.0 % 0.58 [ 0.33, 1.01 ] Total events: 15 (Brief Psychoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.93 (P = 0.054)

0.002 0.1 1 10 500 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 88 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.6. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 6 Relapse: 1. Relapse for any reason.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 6 Relapse: 1. Relapse for any reason

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 medium term Group - Chan 2007 6/44 8/37 12.1 % 0.63 [ 0.24, 1.65 ]

Group - Merinder 1999 14/24 15/22 21.9 % 0.86 [ 0.55, 1.33 ]

Group - Razali 1995 11/85 23/80 33.1 % 0.45 [ 0.23, 0.86 ]

Individual - Cunningham 2001 22/61 22/53 32.9 % 0.87 [ 0.55, 1.38 ] Subtotal (95% CI) 214 192 100.0 % 0.70 [ 0.52, 0.93 ] Total events: 53 (Brief Psychoeducation), 68 (Routine care) Heterogeneity: Chi2 = 3.46, df = 3 (P = 0.33); I2 =13% Test for overall effect: Z = 2.45 (P = 0.014) 2 long term Group - Hornung 1995 30/67 30/57 100.0 % 0.85 [ 0.59, 1.22 ] Subtotal (95% CI) 67 57 100.0 % 0.85 [ 0.59, 1.22 ] Total events: 30 (Brief Psychoeducation), 30 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.87 (P = 0.38) 3 long term (at 5 years follow-up) Group - Hornung 1995 48/67 46/57 100.0 % 0.89 [ 0.73, 1.08 ] Subtotal (95% CI) 67 57 100.0 % 0.89 [ 0.73, 1.08 ] Total events: 48 (Brief Psychoeducation), 46 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.18 (P = 0.24) Test for subgroup differences: Chi2 = 1.85, df = 2 (P = 0.40), I2 =0.0%

0.2 0.5 1 2 5 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 89 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.7. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 7 Relapse: 2. Relapse with readmission.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 7 Relapse: 2. Relapse with readmission

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 medium term Group - Hornung 1995 30/67 30/57 100.0 % 0.85 [ 0.59, 1.22 ] Subtotal (95% CI) 67 57 100.0 % 0.85 [ 0.59, 1.22 ] Total events: 30 (Brief Psychoeducation), 30 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.87 (P = 0.38) 2 long term Group - Hornung 1995 39/67 40/57 100.0 % 0.83 [ 0.64, 1.08 ] Subtotal (95% CI) 67 57 100.0 % 0.83 [ 0.64, 1.08 ] Total events: 39 (Brief Psychoeducation), 40 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.39 (P = 0.17)

0.01 0.1 1 10 100 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 90 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.8. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Weight Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 short term (ITAQ/KSQ, high = favourable) Both - Tom 1989 12 23.58 (8.19) 12 16.83 (8.12) 14.0 % 6.75 [ 0.22, 13.28 ]

Group - Chan 2009 36 15.03 (5.33) 37 7.54 (6.15) 86.0 % 7.49 [ 4.85, 10.13 ] Subtotal (95% CI) 48 49 100.0 % 7.39 [ 4.94, 9.83 ] Heterogeneity: Chi2 = 0.04, df = 1 (P = 0.84); I2 =0.0% Test for overall effect: Z = 5.92 (P < 0.00001) 2 medium term (ITAQ, high = favourable) Group - Chan 2009 36 14.64 (6.76) 37 9.81 (7.71) 100.0 % 4.83 [ 1.51, 8.15 ] Subtotal (95% CI) 36 37 100.0 % 4.83 [ 1.51, 8.15 ] Heterogeneity: not applicable Test for overall effect: Z = 2.85 (P = 0.0044) Test for subgroup differences: Chi2 = 1.47, df = 1 (P = 0.22), I2 =32%

-20 -10 0 10 20 Favours routine care Favours psychoeducation

Analysis 1.9. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 9 Knowledge: 1b. Average change (UMQ, high = good, data skewed). Knowledge: 1b. Average change (UMQ, high = good, data skewed)

Study Intervention Mean SD N

single session psychoeducation

Individual - Macpherson Psychoeducation 6.4 5.9 22 1996

Individual - Macpherson Routine care 1.0 2.8 20 1996

three session psychoeducation

Individual - Macpherson Psychoeducation 15.00 7.4 22 1996

Psychoeducation (brief) for people with serious mental illness (Review) 91 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Knowledge: 1b. Average change (UMQ, high = good, data skewed) (Continued)

Individual - Macpherson Routine care 1.0 2.8 20 1996

Analysis 1.10. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 10 Knowledge: 1c. Average endpoint (ITAQ, high = good, data skewed) (short term). Knowledge: 1c. Average endpoint (ITAQ, high = good, data skewed) (short term)

Study Intervention Mean SD N

Individual - Cunning- Brief psychoeducation 14.5 5.5 47 ham 2001

Individual - Cunning- Standard care 10.7 5.6 39 ham 2001

Analysis 1.11. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 11 Knowledge: 2. Average endpoint scores (SAUMD, high = poor) (short term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 11 Knowledge: 2. Average endpoint scores (SAUMD, high = poor) (short term)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Group - Chan 2007 44 6.77 (2.56) 37 7.95 (3.2) -1.18 [ -2.46, 0.10 ]

-20 -10 0 10 20 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 92 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.12. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 12 Global state: 2. Average endpoint scale score.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 12 Global state: 2. Average endpoint scale score

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Weight Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 short term (GAF/GAS, high = good) Group - Merinder 1999 22 -53.27 (17.83) 19 -50.63 (15.18) 100.0 % -2.64 [ -12.74, 7.46 ] Subtotal (95% CI) 22 19 100.0 % -2.64 [ -12.74, 7.46 ] Heterogeneity: not applicable Test for overall effect: Z = 0.51 (P = 0.61) 2 medium term (GAF/GAS, high = good) Group - Hornung 1995 26 -56.1 (13) 35 -57.8 (8.3) 76.1 % 1.70 [ -4.00, 7.40 ]

Group - Merinder 1999 22 -62.91 (16.34) 18 -55.39 (16.35) 23.9 % -7.52 [ -17.70, 2.66 ] Subtotal (95% CI) 48 53 100.0 % -0.50 [ -5.48, 4.47 ] Heterogeneity: Chi2 = 2.40, df = 1 (P = 0.12); I2 =58% Test for overall effect: Z = 0.20 (P = 0.84) 3 long term at 2 years(GAS, high = good) Group - Hornung 1995 25 -65.2 (13.7) 34 -58.5 (11.8) 100.0 % -6.70 [ -13.38, -0.02 ] Subtotal (95% CI) 25 34 100.0 % -6.70 [ -13.38, -0.02 ] Heterogeneity: not applicable Test for overall effect: Z = 1.97 (P = 0.049) 4 long term at 5 years or more (GAS, high = good) Group - Hornung 1995 25 -59.8 (9.1) 35 -56 (6.9) 100.0 % -3.80 [ -8.04, 0.44 ] Subtotal (95% CI) 25 35 100.0 % -3.80 [ -8.04, 0.44 ] Heterogeneity: not applicable Test for overall effect: Z = 1.76 (P = 0.079) Test for subgroup differences: Chi2 = 2.27, df = 3 (P = 0.52), I2 =0.0%

-50 -25 0 25 50 Favours routine care Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) 93 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.13. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 13 Service utilisation: rehospitalisation.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 13 Service utilisation: rehospitalisation

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 medium term Group - Aguglia 2007 10/75 13/75 93.6 % 0.77 [ 0.36, 1.64 ]

Group - Coyle 1988 2/17 1/21 6.4 % 2.47 [ 0.24, 24.98 ] Subtotal (95% CI) 92 96 100.0 % 0.88 [ 0.43, 1.79 ] Total events: 12 (Brief Psychoeducation), 14 (Routine care) Heterogeneity: Chi2 = 0.88, df = 1 (P = 0.35); I2 =0.0% Test for overall effect: Z = 0.36 (P = 0.72) 2 long term Group - Aguglia 2007 2/75 8/66 100.0 % 0.22 [ 0.05, 1.00 ] Subtotal (95% CI) 75 66 100.0 % 0.22 [ 0.05, 1.00 ] Total events: 2 (Brief Psychoeducation), 8 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.96 (P = 0.050)

0.02 0.1 1 10 50 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 94 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.14. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 14 Mental state: 1a. Global - average total endpoint scale scores (BPRS, high = poor).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 14 Mental state: 1a. Global - average total endpoint scale scores (BPRS, high = poor)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Weight Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 short term Group - Zhang 2006 30 20.63 (4.3) 30 23.33 (4.15) 100.0 % -2.70 [ -4.84, -0.56 ] Subtotal (95% CI) 30 30 100.0 % -2.70 [ -4.84, -0.56 ] Heterogeneity: not applicable Test for overall effect: Z = 2.47 (P = 0.013) 2 medium term Group - Li 2003 68 20.61 (4.65) 52 25.97 (3.22) 100.0 % -5.36 [ -6.77, -3.95 ] Subtotal (95% CI) 68 52 100.0 % -5.36 [ -6.77, -3.95 ] Heterogeneity: not applicable Test for overall effect: Z = 7.45 (P < 0.00001) Test for subgroup differences: Chi2 = 4.14, df = 1 (P = 0.04), I2 =76%

-10 -5 0 5 10 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 95 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.15. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 15 Mental state: 1b. Global - average change scale scores (GWB/SES, high = good) (medium term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 15 Mental state: 1b. Global - average change scale scores (GWB/SES, high = good) (medium term)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 General Well-being Schedule(GWB) Both - Liu 2004 59 13.13 (1.78) 59 2.24 (3.81) 10.89 [ 9.82, 11.96 ]

2 Rosenberg Self-esteem Scale (SES) Both - Liu 2004 59 9.11 (0.77) 59 1.11 (0.48) 8.00 [ 7.77, 8.23 ]

-10 -5 0 5 10 Favours routine care Favours psychoeducation

Analysis 1.16. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 16 Mental state: 1c. Global - average total endpoint scale scores (BPRS, high = poor, data skewed). Mental state: 1c. Global - average total endpoint scale scores (BPRS, high = poor, data skewed)

Study Intervention Mean SD N short term

Group - Merinder 1999 Psychoeducation 11.41 7.91 22

Group - Merinder 1999 Routine care 13.50 9.54 19 medium term

Group - Chan 2009 Psychoeducation 5.69 7.91 36

Group - Chan 2009 Routine care 8.81 9.58 37 long term

Group - Chan 2009 Psychoeducation 4.5 5.11 36

Group - Chan 2009 Routine care 8.81 9.12 37

Group - Merinder 1999 Psychoeducation 8.86 6.19 22

Psychoeducation (brief) for people with serious mental illness (Review) 96 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Mental state: 1c. Global - average total endpoint scale scores (BPRS, high = poor, data skewed) (Continued)

Group - Merinder 1999 Routine care 10.50 7.37 18

Analysis 1.17. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 17 Mental state: 2a. Speciﬁc symptoms - short term.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 17 Mental state: 2a. Speciﬁc symptoms - short term

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 anxiety Both - Zhang 2004 11/74 22/72 0.49 [ 0.25, 0.93 ]

2 depression Both - Zhang 2004 11/74 23/72 0.47 [ 0.25, 0.88 ]

0.01 0.1 1 10 100 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 97 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.18. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 18 Mental state: 2b. speciﬁc symptoms - average total endpoint scale score (high = poor) (short term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 18 Mental state: 2b. speciﬁc symptoms - average total endpoint scale score (high = poor) (short term)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 anxiety-SAS Both - Zhang 2004 74 40.64 (9.87) 72 46.75 (9.42) -6.11 [ -9.24, -2.98 ]

2 depression-SDS Both - Zhang 2004 74 40.35 (9.47) 72 47.97 (10.75) -7.62 [ -10.91, -4.33 ]

-50 -25 0 25 50 Favours psychoeducation Favours routine care

Analysis 1.19. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 19 Mental state: 2c. Speciﬁc symptoms - average total endpoint scale scores (MADRS, high = poor, data skewed) (short term). Mental state: 2c. Speciﬁc symptoms - average total endpoint scale scores (MADRS, high = poor, data skewed) (short term)

Study Intervention Mean SD N

Individual - Cunning- Brief psychoeducation 11.2 8.3 43 ham 2001

Individual - Cunning- Standard care 11 10.8 39 ham 2001

Psychoeducation (brief) for people with serious mental illness (Review) 98 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.20. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 20 Social functioning: 1a. Average change scores on various scales (high = poor) (medium term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 20 Social functioning: 1a. Average change scores on various scales (high = poor) (medium term)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 MRSS Both - Liu 2004 59 -15.07 (3.67) 59 -1.39 (2.73) -13.68 [ -14.85, -12.51 ]

2 SDSS Both - Liu 2004 59 -2.25 (0.45) 59 -0.29 (0.22) -1.96 [ -2.09, -1.83 ]

-10 -5 0 5 10 Favours psychoeducation Favours routine care

Analysis 1.21. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 21 Expressed emotion: Participants with high EE relatives (FQ).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 21 Expressed emotion: Participants with high EE relatives (FQ)

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 short term - at end of interventions Group - Merinder 1999 10/24 14/22 0.65 [ 0.37, 1.16 ]

2 medium term Group - Merinder 1999 14/24 12/22 1.07 [ 0.64, 1.78 ]

0.1 0.2 0.5 1 2 5 10 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 99 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.22. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 22 Expressed emotion for relatives: Average change scores on FQ scales (high = good).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 22 Expressed emotion for relatives: Average change scores on FQ scales (high = good)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Group - Merinder 1999 18 -0.61 (3.43) 11 2.64 (8.01) -3.25 [ -8.24, 1.74 ]

-100 -50 0 50 100 Favours [Routine care] Favours [Psychoeducation]

Analysis 1.23. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 short term Group - Lv 2007 30 17.35 (2.56) 32 16.72 (3.13) 0.63 [ -0.79, 2.05 ]

2 medium term Group - Lv 2007 30 18.45 (2.25) 32 16.32 (2.17) 2.13 [ 1.03, 3.23 ]

-20 -10 0 10 20 Favours routine care Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) 100 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.24. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 24 Quality of life: 1b. Average endpoint scores (FAD, high = poor).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 24 Quality of life: 1b. Average endpoint scores (FAD, high = poor)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 short term Group - Lv 2007 30 71.26 (9.83) 32 71.68 (10.37) -0.42 [ -5.45, 4.61 ]

2 medium term Group - Lv 2007 30 63.13 (9.86) 32 69.92 (9.74) -6.79 [ -11.67, -1.91 ]

-20 -10 0 10 20 Favours psychoeducation Favours routine care

Analysis 1.25. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 25 Quality of life: 1c. Average endpoint scores (FBIS, high = poor, data skewed). Quality of life: 1c. Average endpoint scores (FBIS, high = poor, data skewed)

Study Intervention Mean SD N

Financial

Individual - Nasr 2009 Psychoeducation + med- 2.37 1.6 52 ication

Individual - Nasr 2009 Medication alone 3.00 1.78 56

Routine

Individual - Nasr 2009 Psychoeducation + med- 1.46 1.61 52 ication

Individual - Nasr 2009 Medication alone 2.38 1.95 56

Leisure

Individual - Nasr 2009 Psychoeducation + med- 1.77 2.08 52 ication

Individual - Nasr 2009 Medication alone 3.46 2.24 56

Psychoeducation (brief) for people with serious mental illness (Review) 101 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Quality of life: 1c. Average endpoint scores (FBIS, high = poor, data skewed) (Continued)

Interaction

Individual - Nasr 2009 Psychoeducation + med- 1.33 1.68 52 ication

Individual - Nasr 2009 Medication alone 2.80 2.08 56

Physical health

Individual - Nasr 2009 Psychoeducation + med- 1.29 1.70 52 ication

Individual - Nasr 2009 Medication alone 1.57 2.15 56

Psychological health

Individual - Nasr 2009 Psychoeducation + med- 1.00 1.35 52 ication

Individual - Nasr 2009 Medication alone 1.75 2.16 56

Analysis 1.26. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 26 Satisfaction with mental health services: 1. Average change score (VSS, high = good) (short term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 26 Satisfaction with mental health services: 1. Average change score (VSS, high = good) (short term)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 patients’ satisfaction Group - Merinder 1999 18 -9.47 (17.46) 14 -7.32 (16.48) -2.15 [ -13.96, 9.66 ]

2 relatives’ satisfaction Group - Merinder 1999 10 -9.56 (28.73) 7 1.25 (16.05) -10.81 [ -32.22, 10.60 ]

-100 -50 0 50 100 Favours routine care Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) 102 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.27. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 27 Satisfaction with mental health services: 2. Average change (VSS Scale, high = good) (long term at 1 year).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 27 Satisfaction with mental health services: 2. Average change (VSS Scale, high = good) (long term at 1 year)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 patients’ satisfaction with relatives’ involvement - mean change Group - Merinder 1999 15 -4.47 (3.13) 15 -0.12 (4.42) -4.35 [ -7.09, -1.61 ]

2 relatives’ involvement satisfaction Group - Merinder 1999 11 -1.34 (5.77) 10 0.83 (3.19) -2.17 [ -6.11, 1.77 ]

3 relatives’ efﬁcacy satisfaction Group - Merinder 1999 12 -1.51 (6.47) 12 0.65 (6.35) -2.16 [ -7.29, 2.97 ]

4 relatives’ intervention satisfaction Group - Merinder 1999 13 -2.83 (9.54) 13 0.6 (6.91) -3.43 [ -9.83, 2.97 ]

-20 -10 0 10 20 Favours routine care Favours psychoeducation

Analysis 1.28. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 28 Patients’ satisfaction with mental health services: average endpoint scores (CSQ, high = good) (short term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 28 Patients’ satisfaction with mental health services: average endpoint scores (CSQ, high = good) (short term)

Brief Psychoed- Mean Mean Study or subgroup ucation Routinecare Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Both - Tom 1989 12 24.58 (1.85) 12 23.42 (3.75) 1.16 [ -1.21, 3.53 ]

-10 -5 0 5 10 Favours routine care Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) 103 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.29. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 29 Adverse event: Death.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 29 Adverse event: Death

Brief Psychoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 medium term Group - Merinder 1999 0/24 1/22 76.4 % 0.31 [ 0.01, 7.16 ]

Individual - Nasr 2009 1/52 0/56 23.6 % 3.23 [ 0.13, 77.48 ] Subtotal (95% CI) 76 78 100.0 % 0.99 [ 0.15, 6.65 ] Total events: 1 (Brief Psychoeducation), 1 (Routine care) Heterogeneity: Chi2 = 1.06, df = 1 (P = 0.30); I2 =6% Test for overall effect: Z = 0.01 (P = 1.0) 2 long term Group - Hornung 1995 1/67 1/57 100.0 % 0.85 [ 0.05, 13.30 ] Subtotal (95% CI) 67 57 100.0 % 0.85 [ 0.05, 13.30 ] Total events: 1 (Brief Psychoeducation), 1 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.12 (P = 0.91) Test for subgroup differences: Chi2 = 0.01, df = 1 (P = 0.93), I2 =0.0%

0.005 0.1 1 10 200 Favours psychoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 104 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 2.1. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Compliance: With medication (numberic compliance scale, high = good).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 1 Compliance: With medication (numberic compliance scale, high = good)

Brief Psychoed- Mean Mean Study or subgroup ucation CBT Difference Weight Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 short term Group - Bechdolf 2004 48 3.7 (0.7) 40 3.9 (0.3) 100.0 % -0.20 [ -0.42, 0.02 ] Subtotal (95% CI) 48 40 100.0 % -0.20 [ -0.42, 0.02 ] Heterogeneity: not applicable Test for overall effect: Z = 1.79 (P = 0.073) 2 medium term Group - Bechdolf 2004 48 3.2 (1) 40 3.5 (0.9) 100.0 % -0.30 [ -0.70, 0.10 ] Subtotal (95% CI) 48 40 100.0 % -0.30 [ -0.70, 0.10 ] Heterogeneity: not applicable Test for overall effect: Z = 1.48 (P = 0.14) 3 long term Group - Bechdolf 2004 25 2.9 (1.1) 16 3.4 (0.7) 100.0 % -0.50 [ -1.05, 0.05 ] Subtotal (95% CI) 25 16 100.0 % -0.50 [ -1.05, 0.05 ] Heterogeneity: not applicable Test for overall effect: Z = 1.78 (P = 0.075)

-1 -0.5 0 0.5 1 Favours psychoeducation Favours CBT

Psychoeducation (brief) for people with serious mental illness (Review) 105 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 2.2. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 2 Relapse: Relapse for any reason (medium term)

Brief Psychoed- Study or subgroup ucation CBT RiskRatio RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Group - Bechdolf 2004 10/48 5/40 1.67 [ 0.62, 4.48 ]

0.2 0.5 1 2 5 Favours psychoeducation Favours CBT

Analysis 2.3. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 3 Service utilisation: hospitalisation (long term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 3 Service utilisation: hospitalisation (long term)

Brief Psychoed- Study or subgroup ucation CBT RiskRatio RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Group - Bechdolf 2004 16/27 6/16 1.58 [ 0.78, 3.20 ]

0.02 0.1 1 10 50 Favours psychoeducation Favours CBT

Psychoeducation (brief) for people with serious mental illness (Review) 106 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 2.4. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 4 Mental state: Speciﬁc - average endpoint PANSS scores (high = poor).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 4 Mental state: Speciﬁc - average endpoint PANSS scores (high = poor)

Brief Psychoed- Mean Mean Study or subgroup ucation CBT Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 short term - positive score Group - Bechdolf 2004 48 11.4 (4.5) 40 11.3 (4.2) 0.10 [ -1.72, 1.92 ]

2 short term - negative score Group - Bechdolf 2004 48 13.1 (5.2) 40 13.9 (4.5) -0.80 [ -2.83, 1.23 ]

3 short term - general score Group - Bechdolf 2004 48 25 (6.2) 40 28 (9.2) -3.00 [ -6.35, 0.35 ]

4 medium term - positive score Group - Bechdolf 2004 48 11.4 (4.8) 40 11.6 (43) -0.20 [ -13.59, 13.19 ]

5 medium term - negative score Group - Bechdolf 2004 48 13 (6.1) 40 12.5 (4) 0.50 [ -1.62, 2.62 ]

6 medium term - general score Group - Bechdolf 2004 48 26 (6.9) 40 28.5 (8.8) -2.50 [ -5.85, 0.85 ]

7 long term - positive score Group - Bechdolf 2004 25 13.5 (6.6) 16 13.6 (5.6) -0.10 [ -3.87, 3.67 ]

8 long term - negative score Group - Bechdolf 2004 25 14.5 (6.3) 16 13.7 (5) 0.80 [ -2.68, 4.28 ]

9 long term - general score Group - Bechdolf 2004 25 26.4 (6.9) 16 28.1 (6.3) -1.70 [ -5.80, 2.40 ]

-10 -5 0 5 10 Favours psychoeducation Favours CBT

Psychoeducation (brief) for people with serious mental illness (Review) 107 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 2.5. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 5 Quality of life: Average endpoint MSQoL-54 score (high = good).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 5 Quality of life: Average endpoint MSQoL-54 score (high = good)

Brief Psychoed- Mean Mean Study or subgroup ucation CBT Difference Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 short term Group - Bechdolf 2004 35 54.6 (25.7) 28 52.8 (22.7) 1.80 [ -10.17, 13.77 ]

2 medium term Group - Bechdolf 2004 38 65.4 (24) 26 60.9 (21.2) 4.50 [ -6.66, 15.66 ]

-20 -10 0 10 20 Favours psychoeducation Favours CBT

Psychoeducation (brief) for people with serious mental illness (Review) 108 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 3.1. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 1 Compliance: 1a. With medication - non-compliance

Brief Pyschoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 group - short term Group - Dai 2007 3/51 7/51 70.0 % 0.43 [ 0.12, 1.57 ]

Group - Zhang 2006 2/30 3/30 30.0 % 0.67 [ 0.12, 3.71 ] Subtotal (95% CI) 81 81 100.0 % 0.50 [ 0.18, 1.40 ] Total events: 5 (Brief Pyschoeducation), 10 (Routine care) Heterogeneity: Chi2 = 0.16, df = 1 (P = 0.69); I2 =0.0% Test for overall effect: Z = 1.32 (P = 0.19) 2 unclear - short term Unclear - Li 2005 24/143 36/143 100.0 % 0.67 [ 0.42, 1.06 ] Subtotal (95% CI) 143 143 100.0 % 0.67 [ 0.42, 1.06 ] Total events: 24 (Brief Pyschoeducation), 36 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.72 (P = 0.085) 3 both - medium term Both - Liu 2004 3/59 18/59 100.0 % 0.17 [ 0.05, 0.54 ] Subtotal (95% CI) 59 59 100.0 % 0.17 [ 0.05, 0.54 ] Total events: 3 (Brief Pyschoeducation), 18 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 3.01 (P = 0.0026)

0.02 0.1 1 10 50 Favours group brief pyschoeducation Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) 109 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 3.2. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With follow up - loss to follow-up for any reason.

Brief Pyschoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 both - short term - loss to follow-up for any reason Both - Tom 1989 3/15 3/15 100.0 % 1.00 [ 0.24, 4.18 ] Subtotal (95% CI) 15 15 100.0 % 1.00 [ 0.24, 4.18 ] Total events: 3 (Brief Pyschoeducation), 3 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.0 (P = 1.0) 2 group - medium term - loss to follow-up for any reason Group - Coyle 1988 4/17 1/21 2.6 % 4.94 [ 0.61, 40.19 ]

Group - Hornung 1995 15/67 22/57 69.8 % 0.58 [ 0.33, 1.01 ]

Group - Merinder 1999 6/24 9/22 27.6 % 0.61 [ 0.26, 1.44 ] Subtotal (95% CI) 108 100 100.0 % 0.70 [ 0.45, 1.09 ] Total events: 25 (Brief Pyschoeducation), 32 (Routine care) Heterogeneity: Chi2 = 3.89, df = 2 (P = 0.14); I2 =49% Test for overall effect: Z = 1.57 (P = 0.12) 3 individual - medium term - loss to follow-up for any reason Individual - Cunningham 2001 9/61 9/53 100.0 % 0.87 [ 0.37, 2.03 ] Subtotal (95% CI) 61 53 100.0 % 0.87 [ 0.37, 2.03 ] Total events: 9 (Brief Pyschoeducation), 9 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.33 (P = 0.75) 4 group - long term - loss to follow-up for any reason (by 1 year) Group - Aguglia 2007 6/75 9/75 22.7 % 0.67 [ 0.25, 1.78 ]

Group - Bauml 2007 44/125 29/111 77.3 % 1.35 [ 0.91, 2.00 ] Subtotal (95% CI) 200 186 100.0 % 1.19 [ 0.83, 1.72 ] Total events: 50 (Brief Pyschoeducation), 38 (Routine care) Heterogeneity: Chi2 = 1.72, df = 1 (P = 0.19); I2 =42% Test for overall effect: Z = 0.95 (P = 0.34) 5 group - long term - loss to follow-up for any reason (by 2 years) Group - Hornung 1995 19/67 23/57 100.0 % 0.70 [ 0.43, 1.15 ] Subtotal (95% CI) 67 57 100.0 % 0.70 [ 0.43, 1.15 ] Total events: 19 (Brief Pyschoeducation), 23 (Routine care)

0.001 0.01 0.1 1 10 100 1000 Favours group brief pyschoeducation Favours routine care (Continued ... )

Psychoeducation (brief) for people with serious mental illness (Review) 110 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (... Continued) Brief Pyschoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Heterogeneity: not applicable Test for overall effect: Z = 1.40 (P = 0.16) 6 group - long term - loss to follow-up for any reason (by 5 years or more) Group - Hornung 1995 19/67 22/57 100.0 % 0.73 [ 0.44, 1.21 ] Subtotal (95% CI) 67 57 100.0 % 0.73 [ 0.44, 1.21 ] Total events: 19 (Brief Pyschoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.20 (P = 0.23)

0.001 0.01 0.1 1 10 100 1000 Favours group brief pyschoeducation Favours routine care

Analysis 3.3. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 3 Relapse: 1. Relapse for any reason.

Brief Pyschoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 group - medium term Group - Chan 2007 6/44 8/37 18.1 % 0.63 [ 0.24, 1.65 ]

Group - Merinder 1999 14/24 15/22 32.6 % 0.86 [ 0.55, 1.33 ]

Group - Razali 1995 11/85 23/80 49.3 % 0.45 [ 0.23, 0.86 ] Subtotal (95% CI) 153 139 100.0 % 0.61 [ 0.43, 0.89 ] Total events: 31 (Brief Pyschoeducation), 46 (Routine care) Heterogeneity: Chi2 = 3.03, df = 2 (P = 0.22); I2 =34% Test for overall effect: Z = 2.59 (P = 0.0096) 2 individual - medium term Individual - Cunningham 2001 22/61 22/53 100.0 % 0.87 [ 0.55, 1.38 ]

0.2 0.5 1 2 5 Favours group brief pyschoeducation Favours routine care (Continued ... )

Psychoeducation (brief) for people with serious mental illness (Review) 111 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (... Continued) Brief Pyschoed- Study or subgroup ucation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Subtotal (95% CI) 61 53 100.0 % 0.87 [ 0.55, 1.38 ] Total events: 22 (Brief Pyschoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.60 (P = 0.55) 3 group - long term Group - Hornung 1995 30/67 30/57 100.0 % 0.85 [ 0.59, 1.22 ] Subtotal (95% CI) 67 57 100.0 % 0.85 [ 0.59, 1.22 ] Total events: 30 (Brief Pyschoeducation), 30 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.87 (P = 0.38) 4 group - long term (at 5 years follow-up) Group - Hornung 1995 48/67 46/57 100.0 % 0.89 [ 0.73, 1.08 ] Subtotal (95% CI) 67 57 100.0 % 0.89 [ 0.73, 1.08 ] Total events: 48 (Brief Pyschoeducation), 46 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.18 (P = 0.24)

0.2 0.5 1 2 5 Favours group brief pyschoeducation Favours routine care

Analysis 4.1. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Relapse: Relapse for any reason (medium term).

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT Outcome: 1 Relapse: Relapse for any reason (medium term)

Brief Psychoed- Study or subgroup ucation CBT RiskRatio RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Group - Bechdolf 2004 10/48 5/40 1.67 [ 0.62, 4.48 ]

0.2 0.5 1 2 5 Favours psychoeducation Favours CBT

Psychoeducation (brief) for people with serious mental illness (Review) 112 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 4.2. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term)-without assumption.

Brief Psychoed- Study or subgroup ucation CBT RiskRatio RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Group - Bechdolf 2004 8/40 4/31 1.55 [ 0.51, 4.68 ]

0.2 0.5 1 2 5 Favours psychoeducation Favours CBT

Analysis 5.1. Comparison 5 SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance.

Review: Psychoeducation (brief) for people with serious mental illness Comparison: 5 SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 1 Compliance: 1a. With medication - non-compliance

Studyorsubgroup Psychoeducation Routinecare RiskRatio Weight RiskRatio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 short term - with high risk trials Group - Dai 2007 3/51 7/51 15.2 % 0.43 [ 0.12, 1.57 ]

Group - Zhang 2006 2/30 3/30 6.5 % 0.67 [ 0.12, 3.71 ]

Unclear - Li 2005 24/143 36/143 78.3 % 0.67 [ 0.42, 1.06 ] Subtotal (95% CI) 224 224 100.0 % 0.63 [ 0.41, 0.96 ] Total events: 29 (Psychoeducation), 46 (Routine care) Heterogeneity: Chi2 = 0.40, df = 2 (P = 0.82); I2 =0.0% Test for overall effect: Z = 2.15 (P = 0.032) 2 short term - without high risk trials Group - Zhang 2006 2/30 3/30 100.0 % 0.67 [ 0.12, 3.71 ] Subtotal (95% CI) 30 30 100.0 % 0.67 [ 0.12, 3.71 ] Total events: 2 (Psychoeducation), 3 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.46 (P = 0.64)

0.002 0.1 1 10 500 Favours psychoeducation Favours routine care

Table 1. Suggested design of study

Methods Allocation: randomised, fully explicit description of methods of randomisation and allocation concealment. Blinding: single, tested. Setting: community rather than hospital. Duration: 12 weeks treatment, and then follow-up to at least 52 weeks

Participants Diagnosis: schizophrenia (ICD). n = 300.* Age: adults. Sex: both.

Interventions 1. Brief Psychoeducation: didactic interventions of psychoeducation or patient-teaching involving individuals or groups; programmes of 10 sessions or less will be considered as ’brief’. n = 150 2. Standard care. n = 150.

Outcomes General: time to all-cause treatment failure marked by its discontinuation, relapse, general impression of clinician (CGI), career/other, compliance with treatment, healthy days. Mental state: BPRS and PANSS. Global state: CGI (Clinical Global Impression). Quality of life. QOL (Quality of Life Questionnaire). Family burden: FBQ (Family Burden Questionnaire). Social functioning: return to everyday living for 80% of time.* Adverse events: any adverse event recorded. Economic outcomes.

Notes * Powered to be able to identify a difference of ~ 20% between groups for primary outcome with adequate degree of certainty BPRS = Brief Psychiatric Rating Scale ICD = International Classiﬁcation of Diseases PANSS = Positive and Negative Syndrome Scale

Table 2. Reviews suggested by excluded studies

Broad category of com- Intervention Control Excluded study/studies Existing Cochrane re- parison views

Psychoeducation for car- 10 weekly psychoeduca- Routine care Cheng 2005 - ers or family members tion based on the routine care

Psychoeducation (brief) for people with serious mental illness (Review) 114 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Table 2. Reviews suggested by excluded studies (Continued)

Psychoeducation family Routine care Magliano 2004 intervention

Psychoeducation Non speciﬁc group for O’Callaghan 2009 carers or treatment as usual

Standard length Supportive therapy Shin 2002 psychoeducation (10 sessions)

Psychoeducaitonal Drug treatment only Ying 2006 family intervention plus drug therapy

Drug Drug treatment only Xiang 1994 treatment plus psychoeducational family intervention versus; however, only family members of received the psycho education;

Psychoeducational sup- Wait-list group Posner 1992 port-group

Drug treatment plus psy- Control group 1:drug Ran 2003 choeducational fam- treatment only ily intervention; patients Control group 2:no in- relatives were taught the terventions which means basic knowledge of men- medications were not tal disease, treatment, etc neither encouraged or discouraged

Psychoeducation (over 24 sessions of informa- 24 sessions of informa- Carra 2010 Psychoeducation for 10 sessions) tive programme tive programme plus 48 schizophrenia sessions of supportive group programme

21 sessions of psychoed- 21 sessions Chabannes 2009 ucational programme of programme delivering usual information on the disease

Not pure psychoeduca- 24-week psychoed- Contol group 1: 24- Chien 2013 - tion ucation programme con- week mutual support tains elements of inter- group personal skills training Control group 2: standard care

Psychoeducation (brief) for people with serious mental illness (Review) 115 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Table 2. Reviews suggested by excluded studies (Continued)

Psychoeducative coping Supportive Fries 2003 oriented therapy discussion and problem- solving training

’Decision aid’ interven- Routine care Hamann 2006 tion: this intervention provides information about the illness, but it lacks of core elements of psychoeducation

Assertive com- As- McFarlane 1995 munity treatment com- sertive community treat- bined with psychoeduca- ment combined with cri- tional multifamily treat- sis family intervention ment group; psychoeducation is given only as one element of a care package, which includes other elements such as skills training and family support

Other therapy CognitiveTraining Occupational Therapy Pitschel-Walz 2013 Cognitive training and cognitive rehabilitation for mild to moderate Alzheimer’s disease and vascular dementia

Coping oriented therapy No details about the con- Pfammatter 1999 - trol group

Telehealth Usual care Rotondi 2005 -

Booster sessions (of psy- No booster sessions Sibitz 2007 - choeducation)

CONTRIBUTIONSOFAUTHORS SZ - protocol development, data screening and extraction, data entry and analysis. JX - protocol development, data screening and extraction. SS - data extraction, data analysis and report writing. MBJ - protocol development.

Psychoeducation (brief) for people with serious mental illness (Review) 116 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DECLARATIONSOFINTEREST All authors have no known conﬂict of interest, however JX received a grant from the Cochrane Schizophrenia Group to complete this protocol.

SOURCES OF SUPPORT

Internal sources • Cochrane Schizophrenia Group, UK. Provided grant to lead author to help complete this protocol

External sources • Cochrane Collaboration Programme Grant 2011, UK.

DIFFERENCESBETWEENPROTOCOLANDREVIEW None.