Building Employment Skills Through Therapy for Veterans (BESTVet)

Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Behavioral: integrated Cognitive Behavioral Therapy; Behavioral: Computerized cognitive remediation (CCR); Other: Usual Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: integrated CBT with computerized cognitive remediation	Behavioral: integrated Cognitive Behavioral Therapy; Novel CBT paradigm for schizophrenia/schizoaffective disorder; Other Names: iCBT; Behavioral: Computerized cognitive remediation (CCR); Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.; Other Names: CCR
Other: Treatment As Usual	Other: Usual Care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Workforce Participation Measure - Total Number of Jobs Attained	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)	Baseline to post-treatment (18-months)
Overall Job Attainment Proportion	This is the proportion of participants, by group, that attained at least one job during the active portion of the study.	Study start through 18 months of the active portion of the study.
Job Participant Composite-hours Worked	This is a composite of hours work per week X number of weeks worked, in each assessment period.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work Behavior Inventory	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.	Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
Specific Levels of Functioning (SLOF)	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.	Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Steven L. Sayers, PhD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2015
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimated): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Schizoaffective Disorder; Cognition; Cognitive Behavioral Therapy; Vocational Rehabilitation; Supported Employment
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: D1157-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No