Building Employment Skills Through Therapy for Veterans

NCT01992913 | Completed Results

• 1 other identifier: D1157-R
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Cognitive Behavioral Therapy; Cognition; Vocational Rehabilitation; Supported Employment; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Work Behavior Inventory

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

• Specific Levels of Functioning (SLOF)

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

Study Arms (2)

integrated CBT with computerized cognitive remediation

EXPERIMENTAL

integrated CBT with computerized cognitive remediation

Behavioral: integrated Cognitive Behavioral Therapy; Behavioral: Computerized cognitive remediation (CCR)

Treatment As Usual

OTHER

Treatment As Usual

Other: Usual Care

Interventions

integrated Cognitive Behavioral Therapy BEHAVIORAL

Novel CBT paradigm for schizophrenia/schizoaffective disorder

Also known as: iCBT

integrated CBT with computerized cognitive remediation

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)

Also known as: UC

Treatment As Usual

Computerized cognitive remediation (CCR) BEHAVIORAL

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

Also known as: CCR

integrated CBT with computerized cognitive remediation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The population for which this study was designed were highly functionally impaired by serious psychiatric illness as an effort to improve employment outcomes in this vulnerable group. This led to significant problems with the ability for participants to respond to and complete requests for ongoing participation in study activities and assessments. The significant missing data was the result of these issues.

Results Point of Contact

• Title: Steven L. Sayers, Ph.D.
• Organization: Corporal Michael J Crescenz VA Medical Center

steven.sayers@va.gov

(215) 823-5196

Study Officials

• Steven L. Sayers, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 25, 2013
• Study Start: June 12, 2015
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)