COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
NCT ID: NCT02319746
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2013-09-30
2019-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
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.
Cognitive-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.
Control group
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.
Psychoeducation
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.
Interventions
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Cognitive-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.
Psychoeducation
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 Criteria
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Inclusion Criteria
2. \- Being a regular cannabis user according DSM-IV
3. -Being in remission from the first psychotic episode (not exceeding 5 years).
Exclusion Criteria
2. Presenting mental retardation according to DSM-IV criteria.
15 Years
40 Years
ALL
No
Sponsors
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Basque Health Service
OTHER_GOV
Responsible Party
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Itxaso Ortega Gonzalez
Itxsaso Gonzalez Ortega
Locations
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Araba University Hospital
Vitoria-Gasteiz, Alava, Spain
Countries
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References
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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.
Other Identifiers
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COG-CON
Identifier Type: -
Identifier Source: org_study_id
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