COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
- Conditions
- Cannabis AbuseFirst-episode Psychosis
- Interventions
- Behavioral: Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuseBehavioral: Psychoeducation
- Registration Number
- NCT02319746
- Lead Sponsor
- Basque Health Service
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
-
- 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).
- Presenting organic brain pathology.
- Presenting mental retardation according to DSM-IV criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse 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. Control group Psychoeducation 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.
- Primary Outcome Measures
Name Time Method Normalizing the possible alterations in the endogenous cannabinoid system 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.
Changes in the components of the endogenous cannabinoid system 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.
Cannabis use reduction in the follow-up 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
Improvement in the development of psychotic disorder 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).
- Secondary Outcome Measures
Name Time Method Decrease the number of cannabis users 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
Improvement in the psychosocial functioning 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).
Decrease of negative and positive psychotic symptoms 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.
Decrease of manic, depressive and anxiety symptoms 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.
Improvement in the adherence to pharmacological treatment 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.
Withdrawal of patients 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.
Decrease the number of relapses and rehospitalizations 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.
Trial Locations
- Locations (1)
Araba University Hospital
🇪🇸Vitoria, Alava, Spain