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Completed

NCT Number: NCT00203788

Improving Work Outcome in People With 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCLA Neuropsychiatric Institute

Los Angeles, California, 90095-6968, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individual Placement and Support

Behavioral

Supported education/employment

Workplace Fundamentals Module

Behavioral

Group skills training on job/school topics

Brokered Vocational Rehabilitation

Behavioral

Vocational rehabilitation through traditional separate state-funded agency

Oral Risperidone

Drug

Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist

Other names: Risperdal

Skills training group

Behavioral

Group social skills training that did not focus primarily on work situations

Primary outcomes

  1. Return to regular work or school during 18 month trial (SAS Work Section)

    Time frame: Every 3 months

  2. Maintenance of work/school attendance over 18 months (SAS)

    Time frame: Every 3 months

  3. Quality of work functioning on Work Behavior Inventory

    Time frame: Baseline, 6 months, 18 months

Secondary outcomes

  1. Cognitive performance on test battery

    Time frame: Baseline, 6 months, 18 months

  2. Exacerbation or relapse of psychotic symptoms (BPRS)

    Time frame: Every 2 weeks

  3. Retention in treatment

    Time frame: Every 3 months

  4. Awareness of illness (SUMD-R)

    Time frame: Entry, 6 months, 18 months

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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