Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Moss Rehabilitation Research Institute
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01816061
First received: March 19, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD


Condition Intervention Phase
Traumatic Brain Injury
Post-Traumatic Stress Disorder
Behavioral: Experimental - COMPASS
Behavioral: Control - COMPASS
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Level of Community Integration [ Time Frame: baseline assessment will be done within 3 month post-injury and the follow-up assessment up to 6 months ] [ Designated as safety issue: No ]
    Greater score on social reintegration scale


Estimated Enrollment: 110
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.
Behavioral: Experimental - COMPASS
Controlled randomized clinical trail
Active Comparator: 2

Fifty-five participants in the supported discharge, or control, group will not receive the intervention.

Control

Behavioral: Control - COMPASS
Increased hours of patient-provider interactions Group. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DC VA Medical Center

Exclusion Criteria:

  • Unable to provide informed consent and no proxy available.
  • Severe impairment of language or day- to-day memory that would preclude participation in a verbally-based therapy.
  • Life expectancy of less than 36 months.
  • Severe multiple trauma (as judged by the attending physicians and/or investigators that is too severe to participate in this study) such as:

    • severe burns
    • serious organ damage
    • amputations
    • multiple fractures
  • History of substance abuse severe enough to cause neurologic damage, pre-morbid history of neurologic disease (e.g., stroke).
  • Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness as determined by medical history.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816061

Contacts
Contact: Alexander V Libin, PhD (301) 951-8603 Alexander.Libin2@va.gov
Contact: Marc R Blackman, MD (202) 745-8478 Marc.Blackman@va.gov

Locations
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC Recruiting
Washington, District of Columbia, United States, 20422
Contact: Delphyne Bruner    202-745-8328    Delphyne.Bruner@va.gov   
Principal Investigator: Alexander V Libin, PhD         
Sponsors and Collaborators
Moss Rehabilitation Research Institute
Investigators
Principal Investigator: Alexander V Libin, PhD Washington DC VA Medical Center, Washington, DC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01816061     History of Changes
Other Study ID Numbers: D0637-R
Study First Received: March 19, 2013
Last Updated: July 22, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anxiety Disorders
Mental Disorders
Brain Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014