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Building Employment Skills Through Therapy for Veterans (BEST Vet)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
integrated Cognitive Behavioral Therapy
Usual Care
Computerized cognitive remediation (CCR)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognitive Behavioral Therapy, Cognition, Vocational Rehabilitation, Supported Employment, Schizoaffective Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

iCBT

UC

Arm Description

integrated CBT with computerized cognitive remediation

usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Work Behavior Inventory
Measure completed by the supported employment specialist that evaluates work quality in an employment setting.

Full Information

First Posted
November 1, 2013
Last Updated
October 6, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01992913
Brief Title
Building Employment Skills Through Therapy for Veterans
Acronym
BEST Vet
Official Title
Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2015 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Cognitive Behavioral Therapy, Cognition, Vocational Rehabilitation, Supported Employment, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCBT
Arm Type
Experimental
Arm Description
integrated CBT with computerized cognitive remediation
Arm Title
UC
Arm Type
Other
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
integrated Cognitive Behavioral Therapy
Other Intervention Name(s)
iCBT
Intervention Description
Novel CBT paradigm for schizophrenia/schizoaffective disorder
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
UC
Intervention Description
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
Behavioral
Intervention Name(s)
Computerized cognitive remediation (CCR)
Other Intervention Name(s)
CCR
Intervention Description
Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.
Primary Outcome Measure Information:
Title
Workforce Participation Measures
Description
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.
Time Frame
Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
Secondary Outcome Measure Information:
Title
Specific Levels of Functioning (SLOF)
Description
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.
Time Frame
Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
Title
Work Behavior Inventory
Description
Measure completed by the supported employment specialist that evaluates work quality in an employment setting.
Time Frame
Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L. Sayers, PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Building Employment Skills Through Therapy for Veterans

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