Skip to content

Improving Work Outcome in People With Recent-onset Schizophrenia

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00203788
Enrollment
87
Registered
2005-09-20
Start date
1999-05-31
Completion date
2006-12-31
Last updated
2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

work outcome, supported employment, social skills training, risperidone, cognition, first-episode schizophrenia

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.

Interventions

Supported education/employment

BEHAVIORALWorkplace Fundamentals Module

Group skills training on job/school topics

BEHAVIORALBrokered Vocational Rehabilitation

Vocational rehabilitation through traditional separate state-funded agency

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

BEHAVIORALSkills training group

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 InventoryBaseline, 6 months, 18 months

Secondary

MeasureTime frame
Cognitive performance on test batteryBaseline, 6 months, 18 months
Awareness of illness (SUMD-R)Entry, 6 months, 18 months
Exacerbation or relapse of psychotic symptoms (BPRS)Every 2 weeks
Retention in treatmentEvery 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026