Improving Work Outcome in People With Recent-onset Schizophrenia

Study Overview
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Brief Summary
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This study will determine the effectiveness of combining antipsychotic medication with Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or Brokered Vocational Rehabilitation in facilitating the search for appropriate work or schooling and maintaining work or school activities in people with recent-onset schizophrenia.

Detailed Description
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The purpose of this protocol is to test, in recent-onset schizophrenia, the efficacy of a rehabilitative intervention that is designed to enhance the search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. Predictors of work outcome are being assessed in the context of this work rehabilitation and treatment with the second-generation antipsychotic medication, risperidone. The Developmental Processes in Schizophrenic Disorders project involves an ongoing series of longitudinal follow-through studies of individuals with a recent onset of schizophrenia. The current protocol focuses particularly on processes affecting work outcome in this initial period after onset of schizophrenia, drawing on findings that link cognitive deficits in schizophrenia to functional outcome. The protocol is determining the effects on work outcome of a rehabilitative intervention designed to enhance search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. All entering patients are placed on a common antipsychotic medication, oral risperidone, and are provided clinical treatment by a psychiatrist and a case manager. Participating patients are randomly assigned to a combination of Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or to a Brokered Vocational Rehabilitation Model. The protocol is examining the predictors of level of work functioning attained in the context of the work-focused intervention and maintenance on risperidone. Potential neurocognitive and environmental predictors of work and social functioning and clinical course are being examined. Aspects of early perceptual processing, allocation of attention, working memory, secondary verbal memory, and conceptual flexibility that are implicated as influences on functional outcome are assessed, as are potential stresses and supportive influences in the environment.

Official Title
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Developmental Processes in Schizophrenic Disorders: Improving and Predicting Work Outcome in Recent-Onset Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Individual Placement and Support
* Behavioral: Workplace Fundamentals Module
* Behavioral: Brokered Vocational Rehabilitation
* Drug: Oral risperidone
* Behavioral: Skills training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First major psychotic episode within 2 years of study entry RDC schizophrenia or schizoaffective disorder, mainly schizophrenic subtype Residence within commuting distance of UCLA Interest in trying to resume work or school Speaks English Exclusion Criteria: Known neurological disorder Significant and habitual drug abuse or alcoholism within 6 months of psychotic episode or evidence that substance abuse will be a prominent factor in course of illness Mental retardation Treatment with risperidone is contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: 1<br>Individual Placement and Support Plus Workplace Fundamentals Module | Behavioral: Individual Placement and Support<br>* Supported education/employment<br>Behavioral: Workplace Fundamentals Module<br>* Group skills training on job/school topics<br>Drug: Oral risperidone<br>* Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist<br>* Other names: Risperdal;|
| Active Comparator: 2<br>Brokered Vocational Rehabilitation | Behavioral: Brokered Vocational Rehabilitation<br>* Vocational rehabilitation through traditional separate state-funded agency<br>Drug: Oral risperidone<br>* Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist<br>* Other names: Risperdal;Behavioral: Skills training group<br>* Group social skills training that did not focus primarily on work situations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to regular work or school during 18 month trial (SAS Work Section) |  | Every 3 months | 
| Maintenance of work/school attendance over 18 months (SAS) |  | Every 3 months | 
| Quality of work functioning on Work Behavior Inventory |  | Baseline, 6 months, 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance on test battery |  | Baseline, 6 months, 18 months | 
| Exacerbation or relapse of psychotic symptoms (BPRS) |  | Every 2 weeks | 
| Retention in treatment |  | Every 3 months | 
| Awareness of illness (SUMD-R) |  | Entry, 6 months, 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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work outcome, supported employment, social skills training, risperidone, cognition, first-episode schizophrenia