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Completed

NCT Number: NCT02319746

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

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

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Key information

Conditions

First-Episode Psychosis Cannabis Abuse Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Araba University Hospital

Vitoria-Gasteiz, Alava, 01002, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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).

Exclusion criteria

  • Presenting organic brain pathology.
  • Presenting mental retardation according to DSM-IV criteria.

Treatment and study plan

Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

  2. 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).

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Dec 18, 2014
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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