Improving Work Outcome in People With Recent-onset Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Individual Placement and Support; Behavioral: Brokered Vocational Rehabilitation; Behavioral: Workplace Fundamentals Module; Drug: Oral risperidone; Behavioral: Skills training group

• Registration Number: NCT00203788
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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

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.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-05
• Last Update Submitted: 2013-07-28
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Workplace Fundamentals Module	Individual Placement and Support Plus Workplace Fundamentals Module
1	Oral risperidone	Individual Placement and Support Plus Workplace Fundamentals Module
1	Individual Placement and Support	Individual Placement and Support Plus Workplace Fundamentals Module
2	Brokered Vocational Rehabilitation	Brokered Vocational Rehabilitation
2	Oral risperidone	Brokered Vocational Rehabilitation
2	Skills training group	Brokered Vocational Rehabilitation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

UCLA Neuropsychiatric Institute; 🇺🇸 Los Angeles, California, United States