Building Employment Skills Through Therapy for Veterans

Not Applicable

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Other: Usual Care; Behavioral: integrated Cognitive Behavioral Therapy; Behavioral: Computerized cognitive remediation (CCR)

• Registration Number: NCT01992913
• Lead Sponsor: VA Office of Research and Development

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 performance, 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.

Study Timeline

• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Study Start: 2015-06-12
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iCBT	Computerized cognitive remediation (CCR)	integrated CBT with computerized cognitive remediation
UC	Usual Care	usual care
iCBT	integrated Cognitive Behavioral Therapy	integrated CBT with computerized cognitive remediation

Primary Outcome Measures

Name	Time	Method
Workforce Participation Measures	Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)	Measure completed by the independent assessor that evaluates participation in the workforce, including: timing of job attainment, average days worked per week while employed, average hours worked while employed, and total weeks worked while employed.

Secondary Outcome Measures

Name	Time	Method
Work Behavior Inventory	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.
Specific Levels of Functioning (SLOF)	Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)	Measure of multiple areas of functional outcome. The SLOF is a self-report behavioral rating scale used to assess mentally ill patients' level of functioning in the community and in mental hospitals. The 30-item scale emphasizes patients' everyday behaviors rather than emotional or mental capacity, and it focuses on patients' tangible strengths and skills rather than on patients' weaknesses.

Trial Locations

Locations (1)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States