COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE

Study Overview
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Brief Summary
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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: Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment Control group (N=50): standard treatment: psychoeducation + pharmacological treatment

Official Title
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COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE

Conditions
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First-episode Psychosis, Cannabis Abuse

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Having a first psychotic episode. DSM-IV-TR diagnosis of a psychotic disorder (i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, bipolar disorder, atypical psychosis, brief psychotic disorder, or major depressive disorder with psychotic symptoms). - Being a regular cannabis user according DSM-IV -Being in remission from the first psychotic episode (not exceeding 5 years). Exclusion Criteria: Presenting organic brain pathology. Presenting mental retardation according to DSM-IV criteria.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>The subjects of experimental group will receive a cognitive-behavioral treatment program specific for reduce cannabis use composed of 16 weekly sessions (one hour in duration), in addition to regular psychiatric review and pharmacological treatment. The group will consist of 6-8 subjects. | Behavioral: Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse<br>* 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.<br>|
| Active Comparator: Control group<br>The control group will receive standard care for psychotic episodes which includes pharmacological treatment and psychoeducation, following the same format as the experimental group. 16 weekly sessions of psychoeducation (one hour in duration) will be conducted, in addition to regular psychiatric review and pharmacological treatment. Like the experimental group the group will consist of 6-8 subjects. | Behavioral: Psychoeducation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannabis use reduction in the 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 | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up. | 
| Improvement in the development of psychotic disorder | 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). | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 
| Changes in the components of the endogenous cannabinoid system | To determine whether changes in the components of the endogenous cannabinoid system at systematic level are produced in FEP cannabis abusers. | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 
| Normalizing the possible alterations in the endogenous cannabinoid system | 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. | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the number of cannabis users | To determinate the number of patient who use cannabis in the follow-up in each group | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 
| Decrease of negative and positive psychotic symptoms | To compare the decrease of negative and positive psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS), at post-treatment and follow-up. | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 
| Decrease of manic, depressive and anxiety symptoms | 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. | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 
| Improvement in the psychosocial functioning | To compare the improvement of psychosocial functioning in each group by Functioning Assessment Short Test (FAST). | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 
| Improvement in the adherence to pharmacological treatment | To compare the adherence to pharmacological treatment in each group using Morisky-Green Scale. | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 
| Withdrawal of patients | To evaluate percentage of withdrawal in the follow-up. | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up | 
| Decrease the number of relapses and rehospitalizations | To compare the number of relapses and rehospitalizations in in each group. | Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up |