Clinical trial NCT02319746: COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
Official title: COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First-episode Psychosis
Cannabis Abuse
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2014-12-18
Enrollment: 88
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Cannabis use reduction in the follow-up
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.
measure: Improvement in the development of psychotic disorder
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
measure: Changes in the components of the endogenous cannabinoid system
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
measure: Normalizing the possible alterations in the endogenous cannabinoid system
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary outcomes:
measure: Decrease the number of cannabis users
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
measure: Decrease of negative and positive psychotic symptoms
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
measure: Decrease of manic, depressive and anxiety symptoms
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
measure: Improvement in the psychosocial functioning
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
measure: Improvement in the adherence to pharmacological treatment
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
measure: Withdrawal of patients
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
measure: Decrease the number of relapses and rehospitalizations
timeFrame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Araba University Hospital
state: Alava
Study officials:
References:
citation: Gonzalez-Ortega I, Echeburua E, Garcia-Alocen A, Vega P, Gonzalez-Pinto A. Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:372. doi: 10.1186/s13063-016-1507-x.