- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783185
Dual Diagnosis (Psychosis and Cannabismisuse): Comparison of Specialized Treatment Versus Unspecified Treatment
Dual Diagnosis Psychosis and Substance Abuse: Short- and Middle-term Changes in Symptomatology After Visiting a Group Education Programme to Reduce Consumption of Cannabis
Intention of the study is to examine, if the symptomatology of dual diagnosis patients is less severe after a special indication training for reduction of cannabis consumption in comparison to unspecified trainings.
Point of interest is psychopathology and consumerism.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dual diagnosis patients (psychosis and cannabis abuse) account for more clinical admissions than single diagnosis patients.
Cannabis misuse is a known risk factor for recurrence of psychosis.
A specified intervention on the basis of a manual for schizophrenic substance abusers is administered to inpatients in a specialized unit for young schizophrenic patients in a psychiatric hospital.
The control group, same indication (psychotic disorder and cannabis misuse) receives social competence training (specified for schizophrenic patients as well).
Admission to groups is randomly.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Baden-Württemberg
-
Konstanz, Baden-Württemberg, Germany, 78462
- University of Konstanz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of schizophrenia and disorders with psychotic features
- Misuse of cannabis during 12 months preceding admission to hospital
Exclusion Criteria:
- Not able to attend training twice a week for 45 minutes (concentration, attention, psychotic symptoms, agitation)
- Discharge from hospital before completion of training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACT
Anti-Cannabis-Consumption-Training
|
8 sessions within 4 weeks (twice a week, 45 minutes each) Cognitive behavioral therapy with focus on cannabis abuse
|
|
Active Comparator: CG
Control group
|
8 sessions within 4 weeks (twice a week, 45 minutes) training to develop and ameliorate social competences
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PANSS Positive and Negative Symptom Scale
Time Frame: post intervention, six months follow-up
|
post intervention, six months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Urinstatus for cannabinoids
Time Frame: weekly during and post intervention, follow-up
|
weekly during and post intervention, follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hans Watzl, Dr., University of Konstanz
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRET
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