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Improving Work Outcome in People With Recent-onset Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Individual Placement and Support
Workplace Fundamentals Module
Brokered Vocational Rehabilitation
Oral risperidone
Skills training group
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring work outcome, supported employment, social skills training, risperidone, cognition, first-episode schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Neuropsychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Individual Placement and Support Plus Workplace Fundamentals Module

Brokered Vocational Rehabilitation

Outcomes

Primary Outcome Measures

Return to regular work or school during 18 month trial (SAS Work Section)
Maintenance of work/school attendance over 18 months (SAS)
Quality of work functioning on Work Behavior Inventory

Secondary Outcome Measures

Cognitive performance on test battery
Exacerbation or relapse of psychotic symptoms (BPRS)
Retention in treatment
Awareness of illness (SUMD-R)

Full Information

First Posted
September 14, 2005
Last Updated
July 28, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00203788
Brief Title
Improving Work Outcome in People With Recent-onset Schizophrenia
Official Title
Developmental Processes in Schizophrenic Disorders: Improving and Predicting Work Outcome in Recent-Onset Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
work outcome, supported employment, social skills training, risperidone, cognition, first-episode schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Individual Placement and Support Plus Workplace Fundamentals Module
Arm Title
2
Arm Type
Active Comparator
Arm Description
Brokered Vocational Rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement and Support
Intervention Description
Supported education/employment
Intervention Type
Behavioral
Intervention Name(s)
Workplace Fundamentals Module
Intervention Description
Group skills training on job/school topics
Intervention Type
Behavioral
Intervention Name(s)
Brokered Vocational Rehabilitation
Intervention Description
Vocational rehabilitation through traditional separate state-funded agency
Intervention Type
Drug
Intervention Name(s)
Oral risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist
Intervention Type
Behavioral
Intervention Name(s)
Skills training group
Intervention Description
Group social skills training that did not focus primarily on work situations
Primary Outcome Measure Information:
Title
Return to regular work or school during 18 month trial (SAS Work Section)
Time Frame
Every 3 months
Title
Maintenance of work/school attendance over 18 months (SAS)
Time Frame
Every 3 months
Title
Quality of work functioning on Work Behavior Inventory
Time Frame
Baseline, 6 months, 18 months
Secondary Outcome Measure Information:
Title
Cognitive performance on test battery
Time Frame
Baseline, 6 months, 18 months
Title
Exacerbation or relapse of psychotic symptoms (BPRS)
Time Frame
Every 2 weeks
Title
Retention in treatment
Time Frame
Every 3 months
Title
Awareness of illness (SUMD-R)
Time Frame
Entry, 6 months, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith H Nuechterlein, PhD
Organizational Affiliation
University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Neuropsychiatric Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6968
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Nuechterlein KH, Subotnik KL, Ventura J, Gitlin MF, Green MF, Wallace CJ, Becker DR, Liberman RP, Drake RE, Mintz J. Advances in improving and predicting work outcome in recent-onset schizophrenia. Schizophrenia Bulletin 31(2): 530, 2005.
Results Reference
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Improving Work Outcome in People With Recent-onset Schizophrenia

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