Cannabis Abuse, First-episode Psychosis
Conditions
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
Interventions
BEHAVIORALCognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse
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.
BEHAVIORALPsychoeducation
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.
Sponsors
Basque Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. \- 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). 2. \- Being a regular cannabis user according DSM-IV 3. -Being in remission from the first psychotic episode (not exceeding 5 years).
Exclusion criteria
1. Presenting organic brain pathology. 2. Presenting mental retardation according to DSM-IV criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 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 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). |
Countries
Spain
Outcome results
None listed