Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01816061
First received: March 19, 2013
Last updated: January 26, 2015
Last verified: January 2015
  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 (Outcomes Assessor)
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:
  • Change from Baseline in Community Reintegration for Injured Service Members at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Measured through Community Reintegration for Injured Service Members (CRIS)

  • Change from Baseline in Community Reintegration for Injured Service Members at 5 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Measured through Community Reintegration for Injured Service Members (CRIS)

  • Change from Baseline in Frontal Systems Behavior Scale at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Measured through Frontal Systems Behavior Scale (FrSBe)

  • Change from Baseline in Frontal Systems Behavior Scale at 5 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Mesaured through Frontal Systems Behavior Scale (FrSBe)


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 trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.
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.
Other Name: Supported discharge group

  Eligibility

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

Inclusion Criteria:

  • TBI of at least mild severity using criteria related to disturbance of consciousness (VHA TBI Comprehensive Evaluation screening tool).
  • Obtained informed consent.
  • Males or females of working age, between the ages of 18 and 55.
  • Medically stable with physician approval to participate
  • Ability to comprehend and communicate in English at a 6th grade level
  • Executive dysfunction as identified by Frontal Systems Rating Scale (FrSBe) and/or other study assessments

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
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: January 26, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Veterans Health
Social Adjustment
Traumatic Brain Injury (TBI)
Post-Traumatic Stress Disorder (PTSD)
Independent Living
Goals
Education

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

ClinicalTrials.gov processed this record on February 27, 2015