NCT02319746

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. 1.Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment
  2. 2.Control group (N=50): standard treatment: psychoeducation + pharmacological treatment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

5 years

First QC Date

December 10, 2014

Last Update Submit

January 15, 2020

Conditions

First-episode PsychosisCannabis Abuse

Outcome Measures

Primary Outcomes (4)

  • Cannabis use reduction in the 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

    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

    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

    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 Outcomes (7)

  • Decrease the number of cannabis users

    Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up

  • Decrease of negative and positive psychotic symptoms

    Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up

  • Decrease of manic, depressive and anxiety symptoms

    Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up

  • Improvement in the psychosocial functioning

    Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up

  • Improvement in the adherence to pharmacological treatment

    Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up

  • +2 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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

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.

Experimental group
PsychoeducationBEHAVIORAL

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.

Control group

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Araba University Hospital

Vitoria-Gasteiz, Alava, 01002, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27473688DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Itxsaso Gonzalez Ortega

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 18, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

ES(1)