Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Building Employment Skills Through Therapy for Veterans (BEST Vet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992913
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
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 is to compare iCBT to the usual care (UC) that Veteran's receive. The investigators will compare 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) Not Applicable

Detailed Description:
The objective of the current proposal is 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 includes computerized cognitive remediation. The primary specific aim is 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 are 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 12, 2015
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: iCBT
integrated CBT with computerized cognitive remediation
Behavioral: integrated Cognitive Behavioral Therapy
Novel CBT paradigm for schizophrenia/schizoaffective disorder
Other Name: 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 Name: CCR

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 Name: UC




Primary Outcome Measures :
  1. Workforce Participation Measures [ Time Frame: 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 :
  1. Specific Levels of Functioning (SLOF) [ Time Frame: 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.

  2. Work Behavior Inventory [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992913


Locations
Layout table for location information
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Steven L. Sayers, PhD Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01992913    
Other Study ID Numbers: D1157-R
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
Schizophrenia
Cognitive Behavioral Therapy
Cognition
Vocational Rehabilitation
Supported Employment
Schizoaffective Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders