BEST Vet: Building Employment Skills Through Therapy for Veterans

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT01992913

Collaborator

(none)

Enrollment

Location

Arms

62.7

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder	Behavioral: integrated Cognitive Behavioral Therapy Other: Usual Care Behavioral: Computerized cognitive remediation (CCR)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia

Actual Study Start Date :

Jun 12, 2015

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iCBT 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: UC usual care	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

Arm

Intervention/Treatment

Experimental: iCBT

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: UC

usual care

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:

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)