The Pain Course: a Randomised Controlled Trial Comparing a Remote-Delivered Chronic Pain Management Program When Provided in Online and Workbook Formats B.F

Research Paper

The pain course: a randomised controlled trial comparing a remote-delivered chronic pain management program when provided in online and workbook formats B.F. Deara,*, M. Gandya, E. Karina, T. Ricciardia, V.J. Fogliatia, S. McDonalda, L.G. Staplesa, K. Nicholson Perryb, L. Sharpec, M.K. Nicholasd, N. Titova

Abstract This study compared a remote-delivered pain management program, the Pain Course, when delivered in online and workbook formats. Participants (n 5 178) were randomised into 2 groups: (1) an Internet Group (n 5 84) who were provided with secure accounts to the program in an online format; or (2) a Workbook Group (n 5 94) who were mailed workbook versions of the program. The content of both programs was identical and comprised 5 core lessons, which participants were encouraged to work through over an 8-week period, according to a prescribed timetable. All participants were provided with weekly contact with a clinical psychologist through email and telephone throughout the program. The overall findings suggest that the workbook format was no less effective or acceptable than the validated online format. Significant improvements (avg. improvement; Internet Group vs Workbook Group) in levels of disability (PDI: 16% vs 24%; RMDQ: 12% vs 15%), anxiety (GAD-7: 36% vs 26%), and depression (PHQ-9: 36% vs 36%) were observed in both groups immediately posttreatment. Further improvements were observed in disability levels to 3-month follow-up, and improvements across the other primary outcomes were maintained until 12-month follow-up. High treatment completion rates and levels of satisfaction were reported in both groups, and both groups required a similarly small amount of clinician contact per participant (M 5 74.85 minutes; SD 5 41.03). These results highlight the public health potential of remote-delivered pain management programs, delivered in either workbook or online formats, as methods of increasing access to pain management. Keywords: Pain management, Internet delivery, Remote delivery, Workbook, Randomised controlled trial

1. Introduction recent years. For example, numerous websites now provide There is substantial support for the effectiveness of pain information and recommendations directly to people with chronic 5,17,41 pain (eg, Refs. 6,59). The potential of having a broader range of management programs for chronic pain. These programs teach participants about chronic pain and about cognitive and health professionals provide pain management programs (eg, behavioural self-management skills that can optimise their Refs. 2,3) and the use of very brief interventions have also been functional abilities, emotional well-being, and overall quality of evaluated with encouraging outcomes (eg, Refs. 9,28). Another life. There is widespread recognition that many patients are approach that is receiving considerable interest is the remote delivery of pain management programs through the inter- unable to access these programs in their traditional face-to-face 1,4,16,34 format.24,44 Numerous barriers to treatment exist including the net. Internet-delivered programs use the same principles direct and indirect costs as well as the limited capacity and and content as traditional programs, but are provided remotely availability of traditional services, especially outside major cities. through the internet without the need for clinicians and patients to Several approaches have been used to increase access to meet face to face. The findings of studies examining evidence-based information and pain management programs in internet-delivered pain management programs have been encouraging1,4,16,34 with, for example, studies observing clinically significant improvements in disability, depression, anxiety, and Sponsorships or competing interests that may be relevant to content are disclosed pain with very little clinician contact (eg, Refs. 11,12). at the end of this article. Unfortunately, there are a proportion of people who do not a eCentreClinic, Department of Psychology, Macquarie University, Sydney, b c have reliable internet access and cannot access emerging Australia, Australian College of Applied Psychology, Sydney, Australia, Depart- internet-delivered programs, especially outside major cities ment of Psychology, University of Sydney, Sydney, Australia, d Pain Management Research Institute, Northern Clinical School, Kolling Institute of Medical Research, and with decreasing socioeconomic status and increasing age University of Sydney, Sydney, Australia (eg, Refs. 18,61). One method for overcoming these barriers is *Corresponding author. Address: Department of Psychology, Macquarie University, the remote delivery of programs in more “low tech” formats, Sydney, NSW, Australia. Tel.: 612 9850 9979; fax: 612 9850 8062. E-mail address: such as through hard copy workbooks. Evidence for the [email protected] (B. F. Dear). effectiveness of psychological treatments delivered in work- PAIN 158 (2017) 1289–1301 book form has been available for almost 2 decades for a variety © 2017 International Association for the Study of Pain of common mental health conditions (eg, Ref. 7). To date, http://dx.doi.org/10.1097/j.pain.0000000000000916 several proof-of-concept studies have examined the delivery of

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pain management interventions through workbook with evi- these criteria, 84 were allocated to the Internet Group and 94 dence of good clinical outcomes among those completing the were allocated to the Workbook Group. The CONSORT flowchart programs (eg, Refs. 26,48,53). However, for unknown reasons, for the trial is displayed in Figure 1. these studies have experienced high drop-out rates (eg, . Participants’ primary general practitioner or medical specialist 50%) and never compared the workbook-delivered programs were sent a letter notifying them of their patient’s participation, with other forms of remote-delivered intervention, such as describing the nature of the study and program, and inviting direct internet-delivered programs. contact. The study was approved by the Human Research Ethics This study compared the efficacy and acceptability of Committee (HREC) of Macquarie University, Sydney, Australia, a validated internet-delivered pain management program, the and the trial was registered on the Australian and New Zealand Pain Course, when delivered in workbook and online formats. Clinical Trials Registry (ANZCTR) as ACTRN12614000768695. After a brief telephone screening assessment, participants (n 5 Participant demographic and pain-related characteristics are 178) were randomised to 1 of the 2 groups: (1) the internet- shown in Table 1. delivered pain management group (Internet Group); or (2) the workbook-delivered pain management group (Workbook 2.2. Design and measures Group). It was hypothesised that significant improvements in levels of disability, depression, anxiety, and average pain would The study used a 2 arm CONSORT-revised compliant rando- be observed consistent with previous trials and that no clinically mised controlled trial using an established remote-delivered pain meaningful differences would be observed between the 2 management program, the Pain Course. This study was not groups immediately posttreatment, at 3-month follow-up or at formally designed as a noninferiority trial given the lack of clear 12-month follow-up. It was also hypothesised that both agreement or guidelines around what would constitute a clinically treatments would be associated with high levels of acceptability meaningful difference between 2 self-management programs and treatment completion. and inform the selection of a reasonable noninferiority margin. However, given the evidence for the efficacy of the online Pain 11,12,20 2. Method Course, the online Pain Course format was used in this study as a benchmark with which to compare the efficacy and 2.1. Participants acceptability of the Pain Course in the workbook format. With the Participants read about the study and applied to participate alpha significance level set at 0.05 and power at 0.80, the study through the website of the eCentreClinic (www.ecentreclinic.org). was powered a priori to detect moderate-to-large effect size (ie, The eCentreClinic is a specialist research unit that offers Cohen d $ 0.40) differences between the 2 treatment formats at members of the public the opportunity to participate in clinical each time point. trials and receive access to free self-management programs for All outcome measures were administered online. The primary a range of conditions, including chronic pain. The eCentreClinic endpoints of this study were posttreatment and 3-month follow- can be located through online searches and is promoted by up. The primary and secondary measures were administered at various health care professionals and through numerous initial assessment, pretreatment, midtreatment, posttreatment, websites within Australia. This trial was also promoted through 3-month follow-up, and 12-month follow-up. Pain was consid- paid online advertisements and through unpaid general adver- ered a secondary outcome because the program focuses on the tisements by a range of governmental and non–governmental management of pain-related disability and emotional well-being. organisations providing services to adults with chronic pain, The tertiary measures were administered at pretreatment, including Chronic Pain Australia, the Australian Pain Management posttreatment, and at 3-month follow-up, and the acceptability Association, the New South Wales Agency for Clinical Innovation and satisfaction questions were administered at posttreatment. Pain Network, Pain Australia, and Arthritis Australia. The tertiary measures were administered to assess several Two hundred thirty-six people with a broad range of chronic psychological variables, which have been identified in previous pain conditions started applications to participate in this trial. The literature as important psychological targets of face-to-face pain application process involved completing several online ques- management programs and as important factors in biopsy- tionnaires and a brief telephone assessment to ensure partic- chosocial models of chronic pain. However, a comprehensive ipants satisfied the inclusion and exclusion criteria. Applicants examination of these variables is outside the scope of this trial were randomly allocated to 1 of the 2 groups: (1) the internet- and will be reported in subsequent studies. To facilitate high delivered pain management group (Internet Group); or (2) the questionnaire completion rates, participants were sent workbook-delivered pain management group (Workbook Group). several automated email reminders requesting completion of A permuted block randomisation sequence was created by the questionnaires and attempts were made to telephone first author (BFD) using an online randomiser (www.random.org). nonresponders. Participant randomisation occurred at the point of application, using the eCentreClinic software system, before participants had 2.2.1. Primary measures any contact with the researchers or the researchers had the opportunity to review the details of participants’ applications. Of 2.2.1.1. Pain Disability Index (PDI) the 236 people who started an application, 178 met the following inclusion criteria: (1) experienced pain for more than 6 months, (2) The Pain Disability Index (PDI) contains 7 items designed to had their pain assessed by their General Practitioner (GP) or measure the impact of pain on several areas of life: (1) family and a specialist within the last 3 months, (3) were at least 18 years of home responsibilities; (2) recreation; (3) social activity; (4) age, (4) were a resident of Australia, (5) had regular access to occupation; (5) sexual behaviour; (6) self-care; and (7) life support a computer and the internet, (6) were not currently experiencing activities.42 The 7 items ask for ratings of impact on a 10-point very severe symptoms of depression (ie, defined as a total score scale, where 0 reflects no impact and 10 indicates the worst .22 or endorsing a score .2toitem9ofthePatientHealth impact imaginable. Higher scores indicate greater disability. The Questionnaire 9-Item [PHQ-9]30). Of the 178 applicants meeting PDI is widely used and has yielded good psychometric properties

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Figure 1. Participant flowchart from application to 12-month follow-up. 3MFU, 3-month follow-up; 12MFU, 12-month follow-up; NR, no response.

with high levels of internal consistency, test–retest reliability, and therefore available for benchmarking purposes (eg, Ref. 38). The construct validity.52 In this sample, Cronbach a 5 0.85. RMDQ has yielded good psychometric properties with high levels of internal consistency and test–retest reliability.45 In this sample, 2.2.1.2. Roland Morris Disability Questionnaire (RMDQ) Cronbach a 5 0.84. The Roland Morris Disability Questionnaire (RMDQ) is a 24- 2.2.1.3. Patient Health Questionnaire 9-Item (PHQ-9) statement checklist designed to measure disability associated with chronic pain.46 The RMDQ asks participants to endorse their The Patient Health Questionnaire 9-Item (PHQ-9) contains 9 ability to do numerous day-to-day physical activities. Higher items which measure the symptoms and severity of depression.30 scores are associated with greater disability. A modified version of Higher scores indicate greater depression symptom severity, and the RMDQ, which is applicable to a broader range of chronic pain a total score of $10 is indicative of a major depressive disorder.30 conditions (ie, references to “my back pain” changed to “my The PHQ-9 has been found to have good psychometric pain”),38 was used in this study. This version of the RMDQ is properties30 and to be sensitive to treatment-related change.56 widely used in Australia, and considerable normative data are In this sample, Cronbach a 5 0.83.

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Table 1 Demographic and clinical characteristics of the 2 groups. Variable Internet Group Workbook Group Overall n (%) n (%) n (%) Sex Male 13 (17) 16 (18) 29 (18) Female 63 (83) 72 (82) 135 (82) Age Mean 47.43 (12.19) 48.19 (14.98) 47.84 (13.72) Range 24-79 23-93 23-93 Marital status Single 19 (25) 22 (25) 41 (25) Married/de facto 40 (53) 50 (57) 90 (55) Separated or divorced or widowed 15 (20) 11 (13) 26 (16) Education High school or less 21 (28) 22 (25) 43 (26) Certificate or diploma or other 33 (43) 26 (30) 59 (36) University 22 (29) 40 (45) 62 (38) Employment or vocational status* Full-time employment 17 (22) 23 (26) 40 (24) Part-time employment 15 (20) 10 (11) 25 (15) Casual employment or volunteer 12 (16) 23 (26) 35 (21) Full-time or part-time student 4 (5) 10 (11) 14 (9) Unemployed 13 (17) 13 (15) 26 (16) Registered disability 19 (25) 20 (23) 39 (24) Retired 10 (13) 14 (16) 24 (15) Mean pain duration (y) 9.90 (6.65) 8.27 (7.52) 9.03 (7.15) Average number of pain sites 3.96 (1.70) 4.07 (1.71) 4.02 (1.70) Pain location Head or face or mouth 30 (40) 38 (43) 68 (42) Throat or neck or shoulders 49 (65) 55 (63) 104 (63) Upper arm or forearm or wrist or hand 39 (51) 53 (60) 92 (56) Chest or abdomen or pelvis 37 (49) 46 (52) 83 (51) Upper back or lower back 68 (90) 57 (65) 125 (76) Buttocks or hips or anus 36 (47) 46 (52) 82 (50) Upper leg or knee or lower leg or ankle or foot 55 (72) 68 (77) 123 (75) Prescription medications Pain 65 (86) 71 (81) 136 (83) Mental health 46 (61) 39 (44) 85 (52) Prescription medications reported† Strong opioid analgesics 24 (32) 26 (30) 50 (31) Weak opioid analgesics 28 (37) 24 (27) 52 (32) Nonsteroidal anti-inflammatories 12 (16) 12 (14) 24 (15) Disease-modifying antirheumatics 4 (5) 6 (7) 10 (6) Anticonvulsants 28 (37) 24 (27) 52 (32) Benzodiazepines 13 (17) 15 (17) 28 (17) Anxiolytics and antidepressants 48 (63) 41 (47) 89 (54) Other pain or pychotropic medication 35 (46) 34 (39) 69 (42) Mean number of prescription medications* 2.89 (1.79) 2.55 (1.79) 2.71 (1.79) SDs are shown in parentheses. All data were self-reported. Numbers and percentages rounded to the nearest whole number. * Categories of employment and vocational status were not mutually exclusive; participants could indicate more than 1 to best describe their situation. † Only prescription medications for pain, a pain-related condition, anxiety, or depression are reported. Strong opioids; buprenorphine, fentanyl, hydromorphone, methadone, morphine, and oxycodone; weak opioids; codeine, tramadol, and tapentadol; anxiolytics and antidepressants; beta-blockers, selective serotonin reuptake inhibitors, norepinephrine, and serotonin–norepinephrine reuptake inhibitors, tricyclics, and tetracyclics; other psychotropic or pain medications; including corticosteroids, antispasmodics, serotonin agonists, dopamine agonists, antipsychotics, and psychostimulants.

2.2.1.4. Generalized Anxiety Disorder 7-Item Questionnaire be sensitive to treatment-related change.13 In this sample, (GAD-7) Cronbach a 5 0.87. The Generalized Anxiety Disorder 7-Item (GAD-7) Questionnaire 2.2.2. Secondary measure contains 7 items designed to measure symptoms of anxiety and is sensitive to DSM-IV congruent generalised anxiety disorder, 2.2.2.1. Wisconsin Brief Pain Questionnaire (WBPQ) panic disorder, and social anxiety disorder, with higher scores indicating greater severity of anxiety symptoms.33,49 The GAD-7 The Wisconsin Brief Pain Questionnaire (WBPQ) is designed to has been found to have good psychometric properties33 and to assess the location, severity, and duration of a person’s pain as

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well as the level of interference associated with pain.8 Only the 4 Pain Course.11,12,20,21 Several qualitative and free response WBPQ items concerning the intensity of participants’ current questions were also posed to participants to guide future pain, average pain, least pain, and worst pain over the last month revisions and improvements to the course. were used in this study. These items ask for ratings of pain on a 10-point scale, where 0 reflects no pain and 10 indicates the 2.3. Treatment program worst pain imaginable. The Pain Course is an efficacious internet-delivered pain management program based on principles of cognitive behaviour 2.2.3. Tertiary measures 10–12,20,21 therapy. The Pain Course is based on a pragmatic model of treatment that aims to: (1) provide information that helps 2.2.3.1. Pain Self-Efficacy Questionnaire (PSEQ) participants to understand and deconstruct their symptoms and The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 state- difficulties; (2) teach a range of self-management skills to help ments regarding a patient’s beliefs about his or her ability to participants manage their symptoms and difficulties; and (3) undertake a number of daily tasks with pain.37 Higher scores reduce pain-related disability and improve emotional well-being indicate greater pain-related self-efficacy. Pain self-efficacy is by encouraging the practice and adoption of the skills taught believed to be an important psychological target of effective pain within the program. The Pain Course was designed based on the management programs, and the PSEQ has been found to principles of transdiagnostic psychological interventions (eg, Ref. possess good internal consistency and test–retest reliability.37 In 55) and therefore provides therapeutic information and teaches this sample, Cronbach a 5 0.90. self-management skills that are applicable to a broad range of pain conditions and psychological difficulties. An overview of the 2.2.3.2. TAMPA Scale of Kinesiophobia (TSK) structure, content, and skills taught within the Pain Course is provided in Table 2. The TAMPA Scale of Kinesiophobia (TSK) contains 17 statements 29 The Pain Course consists of 5 core online lessons and 5 lesson and is designed to measure fears of movement and re-injury. summaries, which provide homework assignments to assist Higher scores indicate higher fears of movement and re-injury. participants to learn and apply the skills described in the lessons. Fear of movement is believed to be an important psychological Participants are strongly encouraged to practice the skills taught target of effective pain management programs. The TSK has within the course on a daily basis and to gradually adopt them into been found to predict behavioural performance on movement 60 their everyday lives. Additional resources are provided to tasks and has been found to possess good levels of internal introduce additional topics and skills that are relevant for many 51 a 5 consistency and reliability. In this sample, Cronbach 0.76. participants, but which are not described within the core lessons, 2.2.3.3. Chronic Pain Acceptance Questionnaire 8-Item including materials on working with health professionals and (CPAQ-8) treatments for chronic pain, managing sleep, problem solving, controlling attention, and assertive communication. Based on the The Chronic Pain Acceptance Questionnaire 8-Item (CPAQ-8) experiences of people with chronic pain who have previously contains 8 items designed to measure acceptance in the context completed the course, comprehensive case stories are provided, 19 of chronic pain. Higher scores indicate greater willingness to which describe how people with chronic pain apply the in- experience and acceptance of pain. Pain acceptance is believed formation and skills covered in the course. to be an important psychological target of effective pain Each lesson was presented in the form of a slide show, which management programs, and the CPAQ-8 has been found to took approximately 10 to 20 minutes to read, and was designed 19 possess good psychometric properties. In this sample, to be easily read by someone without high school reading Cronbach a 5 0.76. proficiency. Each lesson comprised approximately 70 slides, and each slide contained approximately 100 to 200 words. The lesson 2.2.3.4. Pain Catastrophising Scale (PCS) materials were presented in a didactic format and included The Pain Catastrophising Scale (PCS) contains 13 items realistic examples of skills practice and symptom management, designed to measure the tendency to magnify the threat value which were strategically integrated throughout the lessons to aid of ongoing pain.50 Higher scores indicate a greater tendency to learning. Each lesson began with a summary of the content of magnify the threat and significance of pain. Pain catastroph- previous lessons. The lessons also included summaries of key izing is believed to be an important psychological target of points interspersed throughout, and concepts and skills de- effective pain management programs and has been found to scribed in previous lessons were often repeated and integrated possess good psychometric properties.39,50 In this sample, with novel information introduced in later lessons. Cronbach a 5 0.92. 2.4. Internet vs workbook groups 2.2.4. Acceptability and satisfaction The Internet Group received the Pain Course in its original online Treatment satisfaction and acceptability was assessed at format and were provided with a personal, password-protected posttreatment by 3 questions: (1) “Overall, how satisfied were login to the eCentreClinic software system and to access the you with the Course?”, (2) “Would you feel confident in course. Consistent with previous trials of the online version of the recommending this Course?”, and (3) “Was it worth your time Pain Course,11,12,20,21 participants were sent regular automated doing the Course?”. Participants responded to the first question emails throughout the course. Some emails were triggered based using a 5-point Likert scale, which ranged from “Very Satisfied” to on participant behaviour: Specifically, emails were triggered when “Very Dissatisfied,” and the latter 2 questions with a “Yes” or “No” (1) participants completed a lesson during the course, and when response. These questions have been used in previous research (2) participants had not completed a lesson within 7 days of it examining the acceptability of other internet-delivered treatments becoming available. Emails were also triggered according to the (eg, Refs. 14,54,58) and have been used in previous trials of the course timeline: Specifically, emails were triggered (1) at the

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Table 2 Timetable and content of the pain course. Lesson Time before Lesson content Primary skill taught Additional resources next lesson, wk 1 1 Education about the prevalence of chronic pain and Symptom identification Sleep management symptoms of anxiety and depression. Information Symptom formulation Treatments and working with health professionals about pain perception and the nervous system. Introduction of a cognitive behaviour therapy model and explanation of the functional relationship between physical, thought, and behavioural symptoms. Instructions for identifying their own symptoms and how their symptoms interact. 2 2 Introduction to the basic principles of cognitive Thought monitoring Structured problem solving and worry time therapy and importance of managing thoughts to Thought challenging Challenging beliefs help manage pain but also anxiety and depression. Instructions for monitoring and challenging thoughts. 3 1 Introduction to the physical symptoms of anxiety (ie, Controlled relaxation Attention management and chronic pain hyperarousal) and depression (ie, hypoarousal) and Pleasant activity scheduling their relationship to emotional well-being and managing the impact of chronic pain. Instructions about controlling physical symptoms using de- arousal strategies such as controlled breathing and scheduling pleasant activities. 4 2 Introduction to the behavioural symptoms of Activity pacing Assertive communication anxiety, low mood, and chronic pain. Explanation of Graded exposure the overdoing-underdoing cycle of physical activity and issues around the fear and the avoidance of physical activities. Instructions for pacing and gradually and safely increasing physical activities. 5 2 Information about the occurrence of lapses in pain, Relapse prevention — depression, and anxiety. Information about the Goal setting signs of relapse and the importance of goal setting into the future. Instructions for creating a relapse prevention plan and goal setting.

beginning of each week to let participants know about new the automated emails sent to participants in the Internet Group materials made available that week and to suggest some tasks for were included as brief messages spread throughout the participants to focus on for the week, and (2) at set times when workbook in an attempt to match the messages received by participants were known to commonly experience increases in the Internet Group. symptoms or to have increased difficulties practicing skills. Each email was brief and comprised 2 to 3 paragraphs containing 3 or 4 2.5. Clinical contact concise sentences. Each email used the participant’s first name and was written to convey a warm and supportive tone. Two registered clinical psychologists (authors M.G. and V.J.F.) Participants were encouraged to complete 1 lesson every 7 to with doctoral degrees in Clinical Psychology and several years’ of 10 days and to attempt to regularly practice the skills covered clinical experience provided all clinical contact with participants, within the lesson summaries. All materials were released which occurred through telephone or a secure email system. BFD systematically over 8 weeks and participants were unable to provided weekly supervision sessions to both psychologists, access materials in later weeks without first having read previous during which all participants were reviewed. Supervision was materials. The Internet Group were able to read and review provided at other times as required. Participants in the Internet materials as much as they wanted after the materials had become and Workbook Groups were assigned to one of the clinicians for available. the entire course. Clinicians aimed to provide weekly contact, The Workgroup Group received the Pain Course in a spiral- through telephone or secure email, for a period between 10 and bound, hard copy workbook that was sent to participants by 15 minutes per contact unless more contact was believed to be registered mail. The workbook version was printed in colour, and clinically indicated by the treating psychologist—eg, in the event the content was identical to the online version of the Pain Course. of a marked increase in depression symptoms or suicidal Participants in the Workbook Group were provided with a pre- ideation, or where a participant was having particular difficulty in scribed timetable for working through the Pain Course, which using a skill taught in the course. matched the release of the materials for the Internet Group. The primary purpose of clinician contact was to encourage and Participants were instructed not to access materials before support participants to work through the Pain Course and to indicated and were also encouraged to complete 1 lesson every 7 apply the skills in the context of their symptoms and circum- to 10 days and to regularly practice the skills covered. No stances; rather than providing psychological treatment them- automated emails were sent to the Workbook Group. However, selves. It is important that consistent with previous research,12,27

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clinicians were instructed to (1) answer participants’ questions; this and consistent with expert recommendations,31 missing (2) summarise content; (3) encourage skills practice and reinforce values were simulated and replaced with models that took into progress; (4) enquire about participants’ experiences with the account the degree of lesson completion. course and use of the skills; and (5) normalise challenges in the Several different statistics were calculated for comparison and learning and use of the core skills. Clinicians were instructed not benchmarking purposes. First, the average percentage change to introduce new therapeutic skills not covered within the course. across time was calculated from the GEE analyses for each of the outcome variables with 95% CIs. It is important that to accurately reflect percentage change, a constant of 17 was subtracted from 2.6. Analytic plan TSK scores when calculating percentage change scores to result in All analyses were conducted using SPSS version 21. Participants a minimum score of 0. Second, based on recommendations for who did not start the interventions were not included in any chronic pain interventions36,40 and previous trials of the Pain analyses. Post hoc power calculations were conducted to Course,10–12 the percentage of participants in each group reporting confirm the magnitude of absolute differences in the primary improvements in symptoms of $30% at each time point was and secondary outcomes the study was powered to detect. calculated. Third, Cohen d effect sizes and 95% CIs were also Power analyses were conducted using the statistical package of calculated for the within-group and between-group effects based on “longpower”15 in R43 using the Internet Group as the comparator. the estimated marginal mean values derived from the GEE models. These power analyses were used to identify the smallest differences between the Internet and Workbook Groups that this 3. Results study could detect under 2 assumptions: (1) The Workbook Group condition was at least 50% as effective as the Internet 3.1. Baseline data, adherence, and attrition Group condition; (2) with power set to 0.80 and an alpha The demographic and clinical characteristics of the sample are significance level of 0.05. These power estimates and resultant shown in Table 1. Specific details of participant flow, treatment differences were used to calculate noninferiority margins, which attrition, lesson completion, and questionnaire response are were then used to separate out legitimate and clinically meaning- shown in Figure 1. ful differences from nonlegitimate and clinically nonmeaningful differences that, for example, can result from measurement error and the samples used. Consistent with the interpretation of 3.2. Time spent and summary of contacts noninferiority trials, if the difference for an outcome was not There were no significant differences between the Internet and contained within the confidence intervals (CIs) for the mean Workbook Groups in the amount of overall clinician time required difference between 2 treatment formats, then the workbook (Wald x2 5 0.015, P 5 0.901) or the amount of clinician time spent 22 format could be concluded to be noninferior. on telephone calls with participants (Wald x2 5 0.070, P 5 0.792) A generalised estimation equation (GEE) modelling technique or reading, responding, and sending secure emails (Wald x2 5 was used to model and examine changes in the marginal means 0.114, P 5 0.735). There were also no differences in the average for each outcome and condition over time. Generalised estimation number of telephone calls (Wald x2 5 0.137, P 5 0.711) or secure equation emphasizes the modelling of change in an average group emails (Wald x2 5 0.107, P 5 0.744) with participants. The average effect over time while accounting for within-subject variance with total clinician time per participant was 74.85 minutes (SD 5 41.03), the specification of a working correlation structure. Rather than with an average of 44.65 minutes (SD 5 41.40) in telephone creating conditional interpretation with the use of individual contact and an average of 30.20 minutes (SD 5 17.29) in written intercepts or random slopes, as in traditional mixed linear models, communication. An average of an additional 23.48 minutes (SD 5 the primary emphasis in GEE is to directly model the average 7.75) was required for the initial assessment interviews to 25 group-related change over time. All GEE models specified determine eligibility for the study. An average of 6.89 (SD 5 3.53) a gamma distribution with a log link response scale to address telephone calls were made or received and an average of 6.23 skewness in the dependent variable distributions and an un- (SD 5 2.59) secure emails were sent per participant. structured working correlation matrix to account for the possibility of unique symptom change periods between time points. These 3.3. Treatment satisfaction models enable the measurement of patient change over time and produce change coefficients that reflect the average percentage Of the participants completing the treatment satisfaction ques- change from baseline. Initial assessment was used as baseline for tions at posttreatment, 89% (60/67) and 92% (77/83) of the primary and secondary outcomes. For the tertiary outcomes, participants in the Internet and Workbook Groups, respectively, which were not assessed at initial assessment, pretreatment was reported being satisfied or very satisfied with the course. Similarly, used as baseline for all analyses. SPSS pairwise comparisons 98% (66/67) and 96% (80/83) of participants in the Internet and were used to explore and understand any significant main and Workbook Groups, respectively, reported they would recom- interaction effects observed in the GEE analyses. mend the course to others. Moreover, 98% (66/67) and 94% (78/ To address missing values and consistent with intention-to-treat 83) of participants in the Internet and Workbook Groups, principles, replacement values were generated for all dependent respectively, reported the course was worth their time. There variables under the missing values assumption of missing at were no significant differences between the groups in satisfaction random.32 To determine the suitability of the missing at random with the course (P . 0.05), willingness to recommend the course assumption, an exploration of variables predicting the likelihood of (P . 0.05), or finding the course worth their time (P . 0.05). missing values was conducted47 and, in a stepwise manner, nonpredictive variables were removed.23 These analyses identified 3.4. Primary outcomes lesson completion as the only dominant variable associated with missing values at posttreatment (Wald x2 5 24.038, P , 0.001, Disability was assessed with the RMDQ and the PDI, whereas Nagelkerke R Square 5 46.8%) as well as improvement after depression and anxiety were assessed with PHQ-9 and GAD-7, treatment (eg, PHQ-9, Wald x2 5 24.038, P , 0.001). Reflecting respectively. The mean and SDs for the 2 groups on the primary,

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secondary, and tertiary outcome variables are shown in Table 3. significant Time by Group interaction (Wald x2 5 8.06, P 5 The proportions of participants reporting $30% improvements at 0.089). There was a significant group effect (Wald x2 5 6.19, P 5 each time point and effect sizes are also shown in Table 4. The 0.013) that indicated across time the workbook group had lower GEE analyses revealed significant effects for Time across the average pain levels. Planned contrasts revealed that both groups primary outcomes (Disability PDI: Wald x2 5 136.95, P , 0.001; improved from pretreatment to posttreatment (P , 0.001) and Disability RMDQ: Wald x2 5 75.80, P , 0.001; Depression: Wald that the Workbook Group had lower average pain levels at x2 5 204.43, P , 0.001; Anxiety: Wald x2 5 85.82, P , 0.001), posttreatment (P 5 0.001) and 3-month follow-up (P 5 0.015) but no significant Time by Group interaction (Disability PDI: Wald compared with the Internet Group. However, in contrast with the x2 5 5.09, P 5 0.278; Disability RMDQ: Wald x2 5 3.01, P 5 Workbook Group, the Internet Group reported improvements 0.390; Depression: Wald x2 5 6.66, P 5 0.155; Anxiety: Wald x2 from posttreatment to 3-month follow-up (P 5 0.022) and from 3- 5 2.75, P 5 0.600). Planned contrasts revealed that both the month follow-up to 12-month follow-up (P 5 0.005). No Internet and Workbook Groups improved from baseline to difference was found between the groups at 12-month follow- posttreatment across all the primary outcome domains (Ps , up (P 5 0.302). 0.001). Further improvements were observed from posttreatment to 3-month follow-up on both measures of disability (PDI: P 5 3.6. Tertiary outcomes 0.003; RMDQ: P 5 0.004), with some evidence of further improvement from 3-month follow-up to 12-month follow-up on The tertiary outcomes were pain self-efficacy, fear of movement, one measure of disability (PDI: P 5 0.026). pain acceptance, and pain catastrophising, which were assessed using the PSEQ, TSK, CPAQ-8, and PCS, respectively. The GEE analyses revealed significant effects for Time across the tertiary 3.5. Secondary outcome outcomes (pain self-efficacy: Wald x2 5 68.95, P , 0.001; fear of The secondary outcome was average pain, which was assessed movement: Wald x2 5 100.16, P , 0.001; pain acceptance: using the WBPQ’s average pain item. The GEE analyses revealed Wald x2 5 50.58, P , 0.001; pain catastrophising: Wald x2 5 significant effects for Time (Wald x2 5 125.88, P , 0.001), but no 118.57, P , 0.001), but no significant Time by Group interactions

Table 3 Mean, SDs, and average percentage change from baseline. Estimated marginal mean Percentage change from baseline* Initial Pretreatment Posttreatment 3-month 12-month Posttreatment, % 3-month 12-month application follow-up follow-up follow-up, % follow-up, % Primary outcomes* Disability (PDI) Internet 39.35 (12.90) 38.89 (12.20) 32.96 (14.99) 31.02 (14.90) 27.82 (15.95) 16 [7-24] 21 [12-29] 29 [20-38] Workbook 38.63 (11.35) 36.39 (12.75) 29.33 (13.69) 26.52 (15.57) 25.25 (14.16) 24 [16-31] 31 [22-39] 35 [26-42] Disability (RMDQ) Internet — 14.69 (5.51) 12.94 (5.42) 12.10 (5.64) 10.90 (5.80) 12 [3-20] 18 [9-26] 26 [16-34] Workbook — 13.98 (4.63) 11.89 (5.22) 10.86 (5.58) 10.92 (5.69) 15 [7-22] 22 [14-30] 22 [13-33] Depression (PHQ-9) Internet 12.57 (4.78) 12.27 (5.11) 8.02 (5.37) 7.61 (5.05) 7.11 (4.78) 36 [26-45] 39 [30-48] 43 [34-51] Workbook 11.13 (5.09) 11.18 (5.42) 7.15 (4.47) 7.23 (4.76) 7.91 (4.92) 36 [27-44] 35 [25-43] 29 [19-38] Anxiety (GAD-7) Internet 8.43 (5.04) 8.47 (4.78) 5.40 (4.35) 5.60 (4.10) 5.13 (5.13) 36 [24-47] 34 [22-44] 39 [24-51] Workbook 7.36 (4.76) 7.43 (4.65) 5.47 (4.31) 4.88 (3.89) 4.99 (4.25) 26 [13-38] 34 [22-44] 41 [19-43] Secondary outcome Average Pain (WBPQ) Internet 6.01 (1.52) 5.98 (1.54) 5.40 (1.77) 5.07 (1.91) 4.42 (2.05) 10 [3-16] 16 [8-23] 26 [18-34] Workbook 5.69 (1.31) 5.56 (1.50) 4.52 (1.66) 4.34 (1.89) 4.09 (1.94) 21 [14-26] 24 [16-30] 28 [21-35] Tertiary outcomes Pain Self-efficacy (PSEQ) Internet — 25.79 (11.33) 32.75 (11.68) 31.80 (12.90) — 27 [17-38] 23 [13-35] — Workbook — 28.62 (12.10) 35.03 (12.19) 36.38 (14.16) — 22 [14-32] 27 [17-38] — Fear of movement (TSK) Internet — 39.30 (7.75) 34.25 (7.20) 34.65 (6.77) — 23 [15-30] 21 [14-28] — Workbook — 38.26 (6.71) 34.56 (7.24) 34.29 (7.56) — 17 [10-28] 19 [11-26] — Pain acceptance (CPAQ-8) Internet — 21.32 (6.67) 25.20 (6.56) 24.85 (6.75) — 18 [11-25] 17 [10-24] — Workbook — 23.29 (8.14) 26.29 (7.76) 27.02 (6.80) — 13 [6-20] 16 [10-22] — Pain Catastrophising (PCS) Internet — 23.50 (11.94) 16.05 (10.46) 13.97 (10.81) — 32 [21-41] 41 [29-50] — Workbook — 20.88 (9.94) 14.51 (9.94) 12.25 (9.26) — 31 [20-47] 41 [31-50] — SDs are shown in round parentheses for the mean, and 95% confidence intervals are shown in square parentheses for effect size and percentage change statistics. To accurately reflect percentage change, a constant of 17 was subtracted from TSK scores when calculating percentage change scores. * The percentage change from baseline statistics are estimates of relative change derived from the GEE models conducted separately for each outcome. Baseline was initial application where available and pretreatment where application data were not available. CPAQ-8, Chronic Pain Acceptance Questionnaire 8-Item; GAD-7, Generalised Anxiety Disorder 7-Item Questionnaire; PCS, Pain Catastrophising Scale; PDI, Pain Disability Index; PHQ-9, Patient Health Questionnaire 9-Item; PSEQ, Pain Self-Efficacy Questionnaire; RMDQ, Roland Morris Disability Questionnaire; TSK, Tampa Scale of Kinesiophobia; WBPQ, Wisconsin Brief Pain Questionnaire.

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Table 4 Proportions reporting ‡30% improvement and effect sizes. ‡30% Improvement Within-group Cohen d effect sizes Between-group Cohen d effect sizes Posttreatment, % 3-month 12-month Posttreatment 3-month follow-up 12-month follow-up Posttreatment 3-month follow-up 12-month follow-up follow-up, % follow-up, % Primary outcomes* Disability (PDI) Internet 32 29 43 0.46 [0.13 to 0.78] 0.60 [0.27 to 0.92] 0.79 [0.46 to 1.12] 0.25 [20.06 to 0.56] 0.29 [20.02 to 0.60] 0.17 [20.14 to 0.48] Workbook 40 40 36 0.58 [0.28 to 0.88] 0.74 [0.43 to 1.04] 0.89 [0.57 to 1.19] Disability (RMDQ) Internet 21 38 47 0.32 [0.00 to 0.64] 0.46 [0.14 to 0.78] 0.67 [0.34 to 0.99] 0.20 [20.11 to 0.50] 0.22 [20.09 to 0.53] 0.00 [20.31 to 0.30] Workbook 27 52 60 0.42 [0.12 to 0.72] 0.61 [0.30 to 0.91] 0.59 [0.29 to 0.89] Depression (PHQ-9) Internet 61 66 67 0.90 [0.56 to 1.22] 1.01 [0.67 to 1.34] 1.14 [0.79 to 1.48] 0.18 [20.13 to 0.48] 0.08 [20.23 to 0.38] 20.16 [20.47 to 0.14] Workbook 57 63 52 0.83 [0.52 to 1.13] 0.79 [0.48 to 1.09] 0.64 [0.34 to 0.94] Anxiety (GAD-7) Internet 62 55 66 0.64 [0.31 to 0.97] 0.62 [0.29 to 0.94] 0.65 [0.32 to 0.97] 2 0.02 [20.32 to 0.29] 0.18 [20.13 to 0.49] 0.03 [20.28 to 0.34] Workbook 49 49 55 0.42 [0.12 to 0.71] 0.57 [0.27 to 0.87] 0.53 [0.22 to 0.82] Secondary outcome Average Pain (WBPQ) Internet 22 32 49 0.37 [0.05 to 0.69] 0.54 [0.22 to 0.87] 0.88 [0.54 to 1.21] 0.51 [0.20 to 0.82] 0.38 [0.07 to 0.69] 0.17 [20.14 to 0.47] Workbook 36 41 52 0.78 [0.47 to 1.09] 0.83 [0.52 to 1.13] 0.97 [0.65 to 1.27] 95% confidence intervals are shown in square parentheses for effect sizes. * Baseline was initial application where available and pretreatment where application data were not available. GAD-7, Generalised Anxiety Disorder 7-Item Questionnaire; PDI, Pain Disability Index; PHQ-9, Patient Health Questionnaire 9-Item; RMDQ, Roland Morris Disability Questionnaire; WBPQ, Wisconsin Brief Pain Questionnaire. 1297 1298 B.F. Dear et al.·158 (2017) 1289–1301 PAIN®

(pain self-efficacy: Wald x2 5 2.10, P 5 0.350; fear of movement: observed, consistent with previous trials, and that no clinically Wald x2 5 2.03, P 5 0.362; pain acceptance: Wald x2 5 2.37, P meaningful differences would be observed between the 2 formats 5 0.305; pain catastrophising: Wald x2 5 0.11, P 5 0.945). immediately posttreatment, at 3-month follow-up, or at 12-month Planned contrasts revealed that both the Internet and Workbook follow-up. It was also hypothesised that both treatments would Groups improved from baseline to posttreatment across all the be associated with high levels of acceptability and treatment tertiary outcome domains (Ps , 0.001). Further improvements completion. These hypotheses were supported. The overall were observed for both groups from posttreatment to 3-month findings suggest that the workbook format was no less effective follow-up in pain catastrophising (PCS: P 5 0.001). or acceptable than the validated online format. Both groups reported significant improvements (avg. improvement; Internet Group vs Workbook Group) across the primary outcomes of 3.7. Statistical power and noninferiority disability (PDI: 16% vs 24%; RMDQ: 12% vs 15%), anxiety (GAD- The mean differences and 95% CIs for the 2 groups at each time 7: 36% vs 26%), and depression (PHQ-9: 36% vs 36%) point are shown in Table 5 for the primary and secondary immediately posttreatment. Further improvements were ob- outcomes. Table 5 also shows the absolute differences between served in disability levels to 3-month follow-up (PDI: 21% vs the 2 groups that the study was powered to detect. None of these 31%; RMDQ: 18% vs 22%), and improvements across the other absolute differences on any outcome were contained within the CIs primary outcomes were maintained until 12-month follow-up. of the mean differences at the primary endpoints of posttreatment Significant improvements were also observed in average pain and 3-month follow-up. These findings held at 12-month follow-up levels (WBPQ Average Pain: 10% vs 21%), and a range of the with the exception of depression (measured with the PHQ-9) and other important psychological variables were often targeted in one measure of disability (measured with the RMDQ) where pain management programs. Treatment completion rates and noninferiority could not be determined. The uncertainty at this time satisfaction levels were also high and relatively less clinician time point arose from the lower-bound of the CIs increasing sub- (M 5 74.85 minutes; SD 5 41.03) was needed to support stantially across the measures, whereas the mean differences participants through the program in either format. (PHQ-9 mean difference 520.79; RMDQ mean difference 52 The magnitudes of clinical improvements observed in this 0.02) between the treatment formats remained largely consistent study are consistent with previous trials examining the Pain with the previous time points. Overall, these findings suggest that Course when delivered through the internet.11,12,20,21 These the workbook format should not be considered inferior to the online clinical findings also compare favourably with the published format at the levels of difference the study was powered to detect. results of other internet-delivered1,4,16,34 and face-to-face However, some caution is needed around concluding noninferiority pain management programs.5,17,41 Unfortunately, very few at 12-month follow-up for some outcomes. studies have examined the delivery of pain management programs through workbooks with remote clinician support through telephone, mail, and email. One randomised con- 4. Discussion trolled trial (n 5 34) compared the efficacy of a cognitive This study sought to compare the efficacy and acceptability of an behaviour therapy pain management program when delivered established internet-delivered pain management program, the face-to-face vs through workbook and found similar clinical Pain Course, when delivered in workbook and online formats. It improvements in both formats.48 Another 2 randomised was hypothesised that significant improvements in levels of controlled trials (n 5 90; n 5 23) compared an acceptance disability, depression, anxiety, and average pain would be and commitment therapy pain management program in

Table 5 Mean differences, confidence intervals, noninferiority margins, and conclusions for the primary and secondary outcomes. Mean differences Noninferiority Conclusions Post-treatment 3-Month follow-up 12-month follow-upmargin Posttreatment 3-month 12-month absolute follow-up follow-up difference Primary outcomes Disability (PDI) Internet 3.63 [20.79 to 8.07] 4.50 [20.18 to 9.18] 2.56 [22.09 to 7.22] 23.77 Noninferiority Noninferiority Noninferiority Workbook Disability (RMDQ) Internet 1.04 [20.58 to 2.68] 1.24 [20.48 to 2.96] 20.02 [21.79 to 1.74] 21.23 Noninferiority Noninferiority Not determined Workbook Depression (PHQ-9) Internet 0.86 [20.66 to 2.39] 0.37 [21.13 to 1.88] 20.79 [22.28 to 0.68] 22.03 Noninferiority Noninferiority Not determined Workbook Anxiety (GAD-7) Internet 20.06 [21.39 to 1.26] 0.72 [20.51 to 1.95] 0.14 [21.30 to 1.60] 21.97 Noninferiority Non-inferiority Noninferiority Workbook Secondary outcome Average Pain (WBPQ) Internet 0.88 [0.35 to 1.41] 0.73 [0.14 to 1.31] 0.32 [20.29 to 0.93] 20.39 Noninferiority Noninferiority Noninferiority Workbook 95% confidence intervals are shown in square parentheses. GAD-7, Generalised Anxiety Disorder 7-Item Questionnaire; PDI, Pain Disability Index; PHQ-9, Patient Health Questionnaire 9-Item; RMDQ, Roland Morris Disability Questionnaire; WBPQ, Wisconsin Brief Pain Questionnaire.

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aworkbookformatwithasimpleprogressiverelaxation significant differences as supporting true clinical equivalence. intervention53 and an attention control condition,26 finding It is possible that significant differences would have been evidence of clinical improvements among those receiving the observed had much larger sample sizes and more conserva- workbook-based programs. However, it is important to note tive differences between the treatments been used to de- that these studies all had relatively small sample sizes, involved termine noninferiority. The need for large samples is also at least some initial face-to-face contact, and all observed highlighted by the fact that noninferiority could not be relatively high levels of patient drop-out (eg, .50%). Moreover, determined at 12-month follow-up for 2 outcomes, due to none of these studies compared the workbook-based pro- marked increases in the lower bound of the CIs at that time grams with other remote-delivered pain management pro- point. Nevertheless, with the differences this study was grams, such as emerging internet-delivered programs.35 The powered to detect and the clinical effects observed, the findings of this study, therefore, augment the existing literature findings of this study suggest that any differences between the and suggest that pain management programs can be 2 treatment formats are likely to be relatively small. Another administered in hard copy workbook format and can result in limitation of this study was that applicants with very severe significant clinical outcomes, levels of satisfaction, and symptoms of depression (defined as a PHQ-9 total score .22) treatment engagement without face-to-face contact. at assessment were excluded and referred on to the other, There has been growing interest in initiatives aimed at more specialised, services for immediate treatment. This was increasing access to pain management programs over the last done because there were limited data at study commence- few years, and the internet delivery of these programs is ment that remote treatments were suitable for patients with the attracting significant interest.1,4,16,34 Internet-delivered pro- most severe symptoms of depression. However, recent grams typically comprise a range of online modules, which reports of very similar treatments would suggest that the cover the same information and skills as taught in face-to-face current intervention would likely be suitable for people with very pain management programs. Many also involve regular severe symptoms of depression, provided there is sufficient clinician contact throughout the program, through email and monitoring throughout treatment (eg, Refs. 57,58). Finally, it is telephone, in which the clinician supports participants to learn also important to bear in mind that all participants in this study the information and apply the skills covered. Some of the had to have access to a computer and the internet in order to emerging strengths of internet-delivered programs include participate, which means some caution is required in general- their accessibility and relatively low cost per patient in terms of ising the results to adults who do not use technology at all. clinician time (eg, Ref. 11). However, although the emerging A key strength of this study’s design was that it used the exact evidence for internet-delivered pain management programs is same treatment program and simply provided the program in an very encouraging,1,4,16,34 some people do not have reliable online or workbook format. It is also important to note that this access to the internet and therefore cannot utilise online study used an established treatment program and protocols for programs. For example, research indicates that the propor- the remote delivery of the pain management programs, so tions of people with access to reliable internet is lower outside caution is needed in generalising these findings to other online major cities, amongst those with lower socioeconomic status treatment programs and self-help workbooks. This is important and chronic medical conditions, as well as amongst those with given the large variability in engagement levels and treatment increasing age (eg, Refs. 18,61) all of which are associated with outcomes observed across existing studies of remote treatments greater risk for chronic pain. This means that internet-delivered and the fact that little is currently known about the factors programs should not replace existing face-to-face services, affecting the success of such treatments (eg, Refs. 10,11). Other and highlight the need for effective and acceptable “low tech” strengths of this study include the assessment of a broad range of methods for improving access to pain management programs. outcome domains, the use of a heterogeneous sample, very high The delivery of psychologically based interventions through retention rates, and the inclusion of long-term follow-up, all of workbooks has shown significant promise in other areas for which provide confidence in the findings observed. patients (eg, Ref. 7). Reflecting this, one large online mental In summary, this study aimed to compare the efficacy and health service established to increase access to psychological acceptability of an established pain management program treatment in Australia offers access to its treatment programs delivered in online and workbook formats with regular clinician in both online and workbook formats based on patients needs, support through telephone and email. This study found significant preferences, and access to technology.57,58 The findings of improvements in disability, anxiety, and depression levels, as well this study highlight the potential of similar approaches in the as on a range of other psychological and pain-related outcomes. area of chronic pain and the merit of “low tech” approaches It also found high levels of acceptability and treatment engage- alongside more “high tech” efforts to increase access to pain ment, with no marked or consistent differences between the management programs. program provided in the 2 formats. The pain management This study has a number of strengths and limitations that program also required no face-to-face contact and relatively less need to be considered in interpreting its findings. The main clinician time per participant consistent with previous research. limitation of this study was the absence of a control group, This study highlights the potential of using evidence-based hard which limits the ability to control for general time effects, copy workbooks as a “low tech” alternative for increasing access spontaneous remission, and the impacts of other treatments. to pain management programs alongside rapidly emerging However, previous trials have demonstrated the efficacy internet-delivered pain management programs. of internet-delivered pain management programs over treatment-as-usual control groups,11,12,20 whose symptoms Conflicts of interest statement and difficulties are relatively stable over time without targeted intervention. This study also used a relatively small sample and B. F. Dear and N. Titov are authors and developers of the Pain was only powered to detect marked clinical differences Course, but derive no personal or financial benefit from it. N. Titov between the 2 treatment formats. Consequently, caution is and B. F. Dear are funded by the Australian Government to needed in concluding the absence of any statistically develop and provide a free national online assessment and

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treatment service, the MindSpot Clinic (www.mindspot.org.au), [14] Dear BF, Zou J, Ali S, Lorian C, Johnston J, Sheehan J, Staples LG, for people with anxiety and depression. Gandy M, Fogliati V, Klein B, Titov N. Clinical and cost-effectiveness of clinician-guided internet-delivered cognitive behaviour therapy program for older adults with symptoms of anxiety: a randomised controlled trial. Acknowledgements Behav Ther 2015;46:206–17. [15] Donohue MC, Gamst AC, Edland SD, Donohue MMC. Package The authors gratefully acknowledge all the participants for their “longpower”. Biometrics 2013;53:937–47. involvement and helpful feedback throughout the research. They [16] Eccleston C, Fisher E, Craig L, Duggan GB, Rosser BA, Keogh E. also gratefully acknowledge the reviewers for their helpful Psychological therapies (Internet-delivered) for the management of feedback on earlier versions of this manuscript. This research was chronic pain in adults. Cochrane Database Syst Rev 2014;2:CD010152. [17] Eccleston E, Williams ACDC, Morley S. Psychological therapies for the enabled by funding from the Motor Accident’s Authority of New management of chronic pain (excluding headache) in adults. Cochrane South Wales and the National Health and Medical Research Database Syst Rev 2009;2:CD007407. Council (NHMRC) to BFD via an Australian Public Health [18] Ennis L, Rose D, Denis M, Pandit N, Wykes T. Can’t surf, won’t surf: the Fellowship. The authors thank the Motor Accident’s Authority of digital divide in mental health. J Ment Health 2012;21:395–403. New South Wales, Chronic Pain Australia, the NSW Agency for [19] Fish RA, McGuire B, Hogan M, Morrison TG, Stewart I. Validation of the chronic pain acceptance questionnaire (CPAQ) in an Internet sample and Clinical Innovation Pain Network, Pain Australia, the Australian development and preliminary validation of the CPAQ-8. PAIN 2010;149: Pain Management Association and Arthritis Australia for their 435–43. support of this research. 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