Building Employment Skills Through Therapy for Veterans

Schizophrenia Clinical Trial

— BEST Vet  

Official title:

Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992913
• Other study ID #: D1157-R
• Status: Completed
• Phase: N/A
• Start date: June 12, 2015
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• integrated Cognitive Behavioral Therapy
Novel CBT paradigm for schizophrenia/schizoaffective disorder

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)

Behavioral:
• Computerized cognitive remediation (CCR)
Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)