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

January 15, 2020 updated by: Itxaso Ortega Gonzalez, Basque Health Service

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alava
      • Vitoria, Alava, Spain, 01002
        • Araba University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.
ACTIVE_COMPARATOR: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannabis use reduction in the follow-up
Time Frame: 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
Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.
Improvement in the development of psychotic disorder
Time Frame: 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).
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease of negative and positive psychotic symptoms
Time Frame: 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.
Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease of manic, depressive and anxiety symptoms
Time Frame: 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.
Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Improvement in the psychosocial functioning
Time Frame: 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).
Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Improvement in the adherence to pharmacological treatment
Time Frame: 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.
Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Withdrawal of patients
Time Frame: 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.
Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease the number of relapses and rehospitalizations
Time Frame: 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.
Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2013

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (ESTIMATE)

December 18, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COG-CON

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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