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Improving Work Outcome in People With Recent-onset Schizophrenia

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status and phase

Completed
Phase 4

Conditions

Schizophrenia

Treatments

Behavioral: Brokered Vocational Rehabilitation
Drug: Oral risperidone
Behavioral: Workplace Fundamentals Module
Behavioral: Skills training group
Behavioral: Individual Placement and Support

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00203788
R01MH037705 (U.S. NIH Grant/Contract)
Janssen RIS-USA-67
DAHBR AD-P

Details and patient eligibility

About

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.

Full 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.

Enrollment

87 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

87 participants in 2 patient groups

1
Experimental group
Description:
Individual Placement and Support Plus Workplace Fundamentals Module
Treatment:
Behavioral: Individual Placement and Support
Drug: Oral risperidone
Behavioral: Workplace Fundamentals Module
2
Active Comparator group
Description:
Brokered Vocational Rehabilitation
Treatment:
Behavioral: Skills training group
Behavioral: Brokered Vocational Rehabilitation
Drug: Oral risperidone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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