Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial

Abstract

BackgroundThe 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/designThis 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.DiscussionThis 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 registrationNCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1507-x) contains supplementary material, which is available to authorized users.

Poor medication adherence and risk of relapse associated with continued cannabis use in patients with first-episode psychosis: a prospective analysis

“…Overall, our results suggest that although efforts should no doubt continue to develop more effective interventions to help patients with psychosis to reduce their cannabis use—eg, similar to those cannabis-focused treatment programmes that are currently under assessment, 31 another potential approach to mitigating the harm from cannabis use might lie in ensuring better adherence of patients to their prescribed medication. It is worth noting that despite the identified mediation effect, a considerable proportion of the variance in the risk of relapse and related outcomes remains unexplained, varying between 7% and 25% depending on the specific outcome.…”

Cognitive Behavioral Therapy Program for Cannabis Use Cessation in First-Episode Psychosis Patients: A 1-Year Randomized Controlled Trial

“…This is a single-blind RCT registered in 2014 ( , Identifier NCT02319746). The study protocol is described in a previous article conducted by González-Ortega et al [ 34 ]. This RCT fulfills the CONSORT (CONsolidated Standards of Reporting Trials) guidelines, checklist, and flow diagram ( Figure 1 ).…”

“…The assessment protocol is widely described in a previous article by González-Ortega et al [ 34 ]. Sociodemographic variables (age, gender, educational level, socioeconomic level, employment status, family history of psychiatric disorders) were collected using a clinical interview at baseline.…”