Skip to main content
OpenTrials
Completed

NCT Number: NCT01992913

Building Employment Skills Through Therapy for Veterans

Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive skills, social skills, and functional skills (like employment). There is a new form of cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that specifically addresses the cognitive, social, and functional deficits of schizophrenia/schizoaffective disorder. This study compared iCBT to the usual care (UC) that Veteran's receive. The investigators compared iCBT to UC in subjects with schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE) program, and evaluate whether iCBT is more helpful in improving job attainment, and other areas of functioning, both right after treatment, and 6 months after the end of treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

About this study

The objective of the current study was to evaluate whether integrated cognitive behavior therapy (iCBT) can improve engagement and success in an existing Supported Employment (SE) program among the most functionally disabled patients with schizophrenia/schizoaffective disorder. The iCBT condition also included computerized cognitive remediation. The primary specific aim was to determine whether iCBT will significantly improve work outcomes at post-treatment to a greater extent than Usual Care (UC) in low functioning patients with schizophrenia/schizoaffective disorder who join the SE program. The secondary aims were to evaluate the whether iCBT will significantly improve work outcomes at 6 month follow-up relative to UC, and whether iCBT will improve functional outcomes post-treatment and at follow-up relative to UC in subjects who join the SE program.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of DSM-IV schizophrenia or schizoaffective disorder (SCID)
  • Severe/extreme functional disability [World Health Organization Disability Assessment Scale (WHODAS) score > 50]
  • Clinical stability (as per primary mental health provider)
  • Receiving treatment at the Veterans Administration
  • Minimal engagement in psychiatric rehabilitation services (just psychiatrist and therapist/case management in the last 6 months)
  • Eligible for and willing to be enrolled in Supported Employment program
  • Age 18 to 65
  • Proficient in English
  • Able to give informed consent

Exclusion criteria

  • Neurologic disease or damage that would make the diagnosis of schizophrenia questionable
  • Current opioid or stimulant dependence (SCID)
  • Not appropriate due to safety concerns (based on risk assessment)

Treatment and study plan

Integrated Cognitive Behavioral Therapy

Behavioral

Novel CBT paradigm for schizophrenia/schizoaffective disorder

Other names: iCBT

Usual Care

Other

The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition)

Other names: UC

Computerized cognitive remediation (CCR)

Behavioral

Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.

Other names: CCR

Primary outcomes

  1. Workforce Participation Measure - Total Number of Jobs Attained

    Time frame: Baseline to post-treatment (18-months)

    Measure completed by the support employment specialist that evaluates participation in the workforce: Total number of jobs attained per group across the full length of the study (Baseline to 18 month follow-up, study end)

  2. Overall Job Attainment Proportion

    Time frame: Study start through 18 months of the active portion of the study.

    This is the proportion of participants, by group, that attained at least one job during the active portion of the study.

  3. Job Participant Composite-hours Worked

    Time frame: Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start.

    This is a composite of hours work per week X number of weeks worked, in each assessment period.

Secondary outcomes

  1. Work Behavior Inventory

    Time frame: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)

    Measure completed by the supported employment specialist that evaluates work quality in an employment setting, based on the job supervisor's report, using the overall impression rating, ranging from 1 (consistently needing improvement) to 5 (consistently superior performance). Only the job supervisor's was used, rather than other options possible with the measure.

  2. Specific Levels of Functioning (SLOF)

    Time frame: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)

    This is measure designed to assess individual social, work, and interpersonal functioning of individuals with severe mental illness. The possible total score ranges from 30 - 150 with higher scores representing higher levels of functioning.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia

Acronym: BESTVet

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2013
Registry last updated
Jan 22, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.