Building Employment Skills Through Therapy for Veterans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: integrated Cognitive Behavioral Therapy
* Other: Usual Care
* Behavioral: Computerized cognitive remediation (CCR)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCBT<br>integrated CBT with computerized cognitive remediation | Behavioral: integrated Cognitive Behavioral Therapy<br>* Novel CBT paradigm for schizophrenia/schizoaffective disorder<br>* Other names: iCBT;Behavioral: Computerized cognitive remediation (CCR)<br>* Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.<br>* Other names: CCR;|
| Other: UC<br>usual care | Other: Usual Care<br>* The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition)<br>* Other names: UC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Workforce Participation Measures | 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. | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Levels of Functioning (SLOF) | 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. | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) | 
| Work Behavior Inventory | Measure completed by the supported employment specialist that evaluates work quality in an employment setting. | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Cognitive Behavioral Therapy, Cognition, Vocational Rehabilitation, Supported Employment, Schizoaffective Disorder