Building Employment Skills Through Therapy for Veterans

NCT ID: NCT01992913

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-12
• Study Completion Date: 2020-09-30

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.

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

integrated CBT with computerized cognitive remediation

integrated CBT with computerized cognitive remediation

Group Type: EXPERIMENTAL

integrated Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Novel CBT paradigm for schizophrenia/schizoaffective disorder

Computerized cognitive remediation (CCR)

Intervention Type: BEHAVIORAL

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

Treatment As Usual

Treatment As Usual

Group Type: OTHER

Usual Care

Intervention Type: 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)

Interventions

integrated Cognitive Behavioral Therapy

Novel CBT paradigm for schizophrenia/schizoaffective disorder

Intervention Type: BEHAVIORAL

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)

Intervention Type: OTHER

Computerized cognitive remediation (CCR)

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

Intervention Type: BEHAVIORAL

Other Intervention Names

iCBT; UC; CCR

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven L. Sayers, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D1157-R

Identifier Type: -

Identifier Source: org_study_id