Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse

Study Overview
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Brief Summary
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Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. Prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. We are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.

Detailed Description
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Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. Prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. We are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia. 330 patients with schizophrenia and cannabis abuse or dependence (according to DSM-IV criteria) are randomly assigned to 4 motivational interview during one month or usual intensive treatment. Treatment is conducted in outpatient which are evaluated at the inclusion and at 6 month with Time-Line Follow Bach for the consumption, PANSS score, number of relapse…). A outcome measure was urinalysis results providing an objective measure of cannabis use throughout the six month of the trial.

Official Title
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An Open Multicentric Randomized Clinical Trial Assessing the Impact of Motivational Interviewing on Cannabis Consumption in Patients With Psychiatric Disease

Conditions
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Schizophrenia, Cannabis Dependence, Continuous

Intervention / Treatment
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* Behavioral: Motivational therapy
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Schizophrenia or schizo-affective disorder according to DSM-IV criteria Meeting DSM-IV criteria for actual cannabis abuse or dependance in current and regular contact with mental health service with an age at interview of 18 years or more No evidence of organic brain disease or clinically significant concurrent medical illness or learning disability Written informed consent was obtained from all subjects (patients and parents). EXCLUSION CRITERIA: Not membership to a regime of social security or to a CMU

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Therapy<br>Four motivational interview for cannabis abuse in schizophrenia population during one month | Behavioral: Motivational therapy<br>* One hour of motivational therapy each weak during 4 weeks<br>|
| Other: Usual Care<br>Usual care with intensive psychotherapy | Behavioral: Usual care<br>* Patients received at least six hour of usual therapy, as in the experimental group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannabis consumption evaluated by the Time-Line Follow Back at 6 months with mean percentage of abstinent day |  | inclusion, 3 month, 6 month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS, GAF, number of DSM-IV criteria of cannabis dependence, May scale for treatment response, SF-12, la URICA, number of hospitalisation, mean number of joints per week, D9THC urinanalysis at 6M and cannabis consumption evaluated by the TLFB at 6M | PANSS : global, positive, negative, general scores | inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Cannabis misuse comorbidity, Motivational interview, Randomised open trial