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Cognitive Behavioral Therapy Program for Cannabis Use

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Cognitive Behavioral Therapy Program for Cannabis Use González-Ortega et al. Trials (2016) 17:372 DOI 10.1186/s13063-016-1507-x STUDY PROTOCOL Open Access Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial Itxaso González-Ortega1,2,3*, Enrique Echeburúa1,3, Adriana García-Alocén2, Patricia Vega1,2 and Ana González-Pinto1,2,4 Abstract Background: The high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation). Methods/design: This is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group. Discussion: This study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder. Trial registration: NCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014. Keywords: Cannabis, First-episode psychosis, Psychological treatment * Correspondence: [email protected] 1Center for Biomedical Research in the Mental Health Network (CIBERSAM), Madrid, Spain 2Department of Psychiatry, Araba University Hospital, Olaguibel Street 29, 01004 Vitoria, Spain Full list of author information is available at the end of the article © 2016 González-Ortega et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. González-Ortega et al. Trials (2016) 17:372 Page 2 of 9 Background increased susceptibility to schizophrenia [18]. Remission Substance misuse is a common comorbid problem in pa- of symptoms in schizophrenia has also been associated tients with first-episode psychosis (FEP), cannabis being with significant changes in messenger ribonucleic acid the most commonly abused substance together with al- (mRNA) levels of CB2 in peripheral blood mononuclear cohol in this population [1]. The prevalence of cannabis cells [19]. With respect to other components of the ECS, use among patients with FEP is notably high, at around there is much less information, but alterations in the 65.7% [2]. This has led to the hypothesis that its use may levels of anandamide have been found in the cerebro- have a role in the etiology and evolution of psychosis. It spinal fluid of patients with schizophrenia [20]. has been found that cannabis use may act as a risk factor There is empirical evidence for an influence of canna- influencing age of onset of psychosis [3–8]. Further, bis on the course and outcome of psychosis [21, 22]. young people who abuse cannabis have a higher risk of Cannabis use in early psychosis is correlated with poor developing psychosis than non-abusers, with an earlier adherence to pharmacological treatment [2, 23, 24], the age of onset of psychosis [9]. The risk of developing severity of psychotic symptoms [22] and the risk of re- psychosis is also related to an early age of onset of use lapse [2, 21, 23, 24]. Moreover, patients with FEP who [3, 9–11], and to the severity of use [3, 9], with a fre- use cannabis have a poorer functional outcome at quency- and dose-dependent response, especially in vul- follow-up [22, 25–27]. On the other hand, patients with nerable individuals [3, 12], increasing the risk in the FEP who stop using cannabis experience a slow but general population. steady improvement over time in clinical and functional Recently, it has also been suggested that cannabis outcome [21]. abuse in adolescence can cause alterations in the endo- Cannabis use, due to its influence on the development cannabinoid system (ECS) and that these alterations may and prognosis of the disease, has become a target for the be related to a higher incidence of psychosis and to prevention and treatment of patients with FEP. Such pa- some of the symptoms presented. Specifically, some re- tients, unlike chronic psychotic patients, show a greater search has shown that frequent use of cannabis can variation in the frequency and intensity of cannabis use cause inhibition of the signaling pathways of the main and greater motivation for change at baseline [28]. endocannabinoid, anandamide, in schizophrenia patients Therefore, it is essential to intervene in the early stages but not in healthy individuals [13]. It has also been re- of the disease, before cannabis use becomes established. ported that FEP patients who are cannabis users have What is more, early intervention may be able not only cognitive deficits associated with structural abnormal- to reduce but also to detect this type of substance abuse ities of brain areas with a high level of expression of can- in patients with FEP. nabinoid receptor type 1 (CB1) [14, 15]. Further, it has In a systematic review, Ruiz de Azúa García et al. [29] been shown that the intake of exogenous cannabinoids concluded that several studies have shown that psychoe- could alter synaptic plasticity mediated by the ECS, pos- ducation as an adjuvant to pharmacological treatment is sibly affecting brain maturation during adolescence, and effective in improving negative symptoms and function- in turn, neurodevelopmental processes [16]. ality (Lambeth Early Onset Team Study, UK; Personal The ECS is an endogenous homeostatic system with mul- Assessment and Crisis Evaluation, Australia; OPUS tiple physiological functions and is activated in response to Scandinavia, Denmark; Early Psychosis Prevention and various different stimuli and under different neuropatho- Intervention Centre, Australia). Evidence suggests that logical conditions. It is composed of a series of lipid media- cognitive behavioral therapy may also be effective in FEP tors, known as endocannabinoids, anandamide and [30]. However, despite the recognized clinical conse- 2-arachidonoylglycerol being the most studied; their quences of cannabis use in early psychosis [3–6], only a two classical receptors coupled to G protein, CB1 and few trials have evaluated clinical treatments as a specific cannabinoid receptor type 2 (CB2); and enzymes intervention to reduce cannabis use in this population. responsible for its synthesis, N-acyl-phosphatidyletha- These studies have investigated interventions based on nolamine-selective phospholipase C (NAPE-PLC) and motivational interviewing [31] or combined interven- diacylglycerol lipase (DAG-L), and degradation, fatty tions based on motivational interviewing and cognitive acid amide hydrolase (FAAH) and monoacylglycerol behavioral therapy [32–35]. Generally, the results ob- lipase (MAG-L). tained failed to clearly indicate whether the interventions Some studies have linked the ECS with psychotic ill- were effective in terms of reducing cannabis use and/or ness, especially focusing on CB1 and CB2. In particular, improving clinical outcomes at follow-up. The exception lower expression of CB1 has been observed in several was the study conducted by Madigan et al. [34], in which brain regions of individuals with schizophrenia [17] and patient quality of life improved at post-treatment. Fur- it has also been shown that CB2 loss of function (due to ther, the small sample sizes and the absence of an appro- polymorphisms such as Q63R) is associated with an priate treatment-as-usual control condition in these González-Ortega et al. Trials (2016) 17:372 Page 3 of 9 studies indicate that it is not possible to draw definite to that of standard treatment (psychoeducation + conclusions. pharmacological treatment) in patients with FEP who From reviewing the literature, we conclude that there are cannabis users. is an urgent need to develop effective
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