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General objective: To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users. Design A multicenter single-blind randomized study with 1 year of follow-up. The effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users will be assessed. Patients will be randomly assigned to one of two treatments: 1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment 2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2020-01-18
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This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
The intervention program is focused on reducing the cannabis use, improving awareness of illness, adherence to treatment, identification of prodromes, psychosocial functioning improvement and relapse prevention.
The aim of psychoeducation is that the patient understands and be able to manage the disease providing the tools and skills to symptoms management, to avoid relapse and contribute to their wellbeing.
Eligibility
primary outcomes
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.
To assess whether cannabis focused psychological intervention is associated with a cannabis use reduction according to Europ-ASI scale compared to standard treatment
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To assess whether cannabis focused psychological intervention is associated with an improvement in the development of psychotic disorder (ie, reduction of symptoms and improvement of psychosocial functioning) compared with standard treatment at the end of treatment and at follow-up (at three and six months and one year of follow-up).
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To determine whether changes in the components of the endogenous cannabinoid system at systematic level are produced in FEP cannabis abusers.
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To assess whether treatment program specific for cannabis abstinence is capable of normalizing the possible alterations in the endogenous cannabinoid system in patients that reduce the cannabis use.
secondary outcomes
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To determinate the number of patient who use cannabis in the follow-up in each group
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To compare the decrease of negative and positive psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS), at post-treatment and follow-up.
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To compare the decrease of manic, depressive and anxiety symptoms at post-treatment and follow-up. Manic symptoms will be measured using Young Mania Rating Scale (YMRS). Anxiety and depressive symptoms will be measured using Hamilton Anxiety Scale (HAM-A) and Hamilton Depression Scale (HAM-D), respectively.
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To compare the improvement of psychosocial functioning in each group by Functioning Assessment Short Test (FAST).
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To compare the adherence to pharmacological treatment in each group using Morisky-Green Scale.
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To evaluate percentage of withdrawal in the follow-up.
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To compare the number of relapses and rehospitalizations in in each group.
Publications