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

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ClinicalTrials.gov Identifier: NCT02319746
Recruitment Status : Recruiting
First Posted : December 18, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Itxaso Ortega Gonzalez, Basque Health Service

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

Condition or disease Intervention/treatment Phase
First-episode Psychosis Cannabis Abuse Behavioral: Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse Behavioral: Psychoeducation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
Study Start Date : September 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319746


Contacts
Contact: Itxaso Gonzalez Ortega, PhD +34945007764 ext 5826 ITXASO.GONZALEZORTEGA@osakidetza.net

Locations
Spain
Araba University Hospital Recruiting
Vitoria, Alava, Spain, 01002
Contact: Itxaso González-Ortega, Phd         
Sponsors and Collaborators
Basque Health Service

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Itxaso Ortega Gonzalez, Itxsaso Gonzalez Ortega, Basque Health Service
ClinicalTrials.gov Identifier: NCT02319746     History of Changes
Other Study ID Numbers: COG-CON
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Marijuana Abuse
Schizophrenia Spectrum and Other Psychotic Disorders
Substance-Related Disorders
Chemically-Induced Disorders