Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients
This study will compare employment support with behavioral skills training to employment support alone in schizophrenia patients taking either risperidone or olanzapine to determine which is more effective in helping the patients maintain a job.
Behavioral: Individual Placement and Support (Supported Employment)
Behavioral: Social Skills Training
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training|
- Total Weeks Worked [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Body Mass Index [ Time Frame: First 18 months of study ] [ Designated as safety issue: No ]Intent was to compare medication and not work group conditions. This was initially assessed at baseline and includes total time on either risperidone or olanzapine up to 18 months.
|Study Start Date:||June 2000|
|Study Completion Date:||September 2006|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
|Active Comparator: Risperidone Plus Supported Employment||Behavioral: Individual Placement and Support (Supported Employment) Drug: Risperidone|
|Active Comparator: Olanzapine Plus Supported Employment||Behavioral: Individual Placement and Support (Supported Employment) Drug: Olanzapine|
|Active Comparator: Risperidone+Supported Employment+Skills||Behavioral: Individual Placement and Support (Supported Employment) Behavioral: Social Skills Training Drug: Risperidone|
|Active Comparator: Olanzapine+Supported Employment+Skills||Behavioral: Individual Placement and Support (Supported Employment) Behavioral: Social Skills Training Drug: Olanzapine|
Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty concentrating, and hallucinations. Individuals with schizophrenia often experience reduced emotional, social, and occupational functioning. Data indicate that antipsychotic drug treatment and occupational training and support may be effective in helping people with schizophrenia maintain a stable job. Risperidone and olanzapine are antipsychotic drugs; participants in this study will be taking either risperidone or olanzapine for the duration of the study. This study will provide schizophrenia patients with employment support alone or with behavioral skills training to determine which combination is more effective in helping patients obtain and maintain a job.
At study entry, participants will undergo a clinical and diagnostic evaluation to determine the severity of their schizophrenia. Participants will be tapered off their regular medication for schizophrenia over 4 weeks. At the end of Week 4, they will be randomly assigned to receive either risperidone or olanzapine. Participants will then be assigned an Individual Placement and Support (IPS) specialist to assist them in finding a job. After participants secure a job, they will be randomly assigned to receive IPS either alone or with the Workplace Fundamentals Skills Training Module for 2 years. Participants' risperidone or olanzapine treatment will continue during this 2-year period. Participants will have clinic visits at study entry and Months 7, 12, and 24. At each visit, participants will complete questionnaires and will be interviewed about their schizophrenia symptoms and occupational functioning.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183625
|United States, California|
|West Los Angeles Veterans Healthcare Center|
|Los Angeles, California, United States, 90073|
|United States, New Hampshire|
|Greater Manchester Mental Health Center|
|Manchester, New Hampshire, United States, 03104|
|Principal Investigator:||Stephen R. Marder, MD||University of California, Los Angeles|