Improving Work Outcome in People With Recent-onset Schizophrenia

July 28, 2013 updated by: Keith Nuechterlein, Ph.D., University of California, Los Angeles

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-6968
        • UCLA Neuropsychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 1
Individual Placement and Support Plus Workplace Fundamentals Module
Behavioral: Individual Placement and Support
Supported education/employment
Behavioral: Workplace Fundamentals Module
Group skills training on job/school topics
Drug: Oral risperidone
Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist
Other Names:
  • Risperdal
Active Comparator: 2
Brokered Vocational Rehabilitation
Drug: Oral risperidone
Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist
Other Names:
  • Risperdal
Behavioral: Brokered Vocational Rehabilitation
Vocational rehabilitation through traditional separate state-funded agency
Behavioral: Skills training group
Group social skills training that did not focus primarily on work situations

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Keith H Nuechterlein, PhD, University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 28, 2013

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH037705 (U.S. NIH Grant/Contract)
  • DAHBR AD-P (WHO ICTRP)
  • Janssen RIS-USA-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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