Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS

NCT01816061 | Completed Results

• 1 other identifier: D0637-R
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Brain Injury; Post-Traumatic Stress Disorder

Keywords

Veterans Health; Social Adjustment; Traumatic Brain Injury (TBI); Post-Traumatic Stress Disorder (PTSD); Independent Living; Goals; Education

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Community Reintegration for Injured Service Members at 2 Months

  Change from Baseline in Community Reintegration for Injured Service Members (CRIS) at 2 months. The investigators used in the report CRIS subscale - Extent of Participation, CRIS with the score range 28.0-64.0. Higher scores mean a better outcome for the Extent of Participation, Community Reintegration for Injured Service Members (CRIS)

  Baseline and 2 months

• Change From Baseline in Frontal Systems Behavior Scale at 2 Months

  Change from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.

  Baseline and 2 months

Study Arms (2)

Experimental - COMPASS

EXPERIMENTAL

Goal-setting sessions

Behavioral: Experimental - COMPASS

Control - COMPASS

ACTIVE COMPARATOR

Informative phone calls

Behavioral: Control - COMPASS

Interventions

Experimental - COMPASS BEHAVIORAL

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.

Experimental - COMPASS

Control - COMPASS BEHAVIORAL

Increased hours of patient-provider interactions Group.

Also known as: Supported discharge group

Control - COMPASS

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Related Publications (2)

• Libin AV, Scholten J, Schladen MM, Danford E, Shara N, Penk W, Grafman J, Resnik L, Bruner D, Cichon S, Philmon M, Tsai B, Blackman M, Dromerick A. Executive functioning in TBI from rehabilitation to social reintegration: COMPASS (goal,) a randomized controlled trial (grant: 1I01RX000637-01A3 by the VA ORD RR&D, 2013-2016). Mil Med Res. 2015 Nov 30;2:32. doi: 10.1186/s40779-015-0061-2. eCollection 2015.

  PMID: 26664736 RESULT

• Libin AV, Schladen MM, Danford E, Cichon S, Bruner D, Scholten J, Llorente M, Zapata S, Dromerick AW, Blackman MR, Magruder KM. Perspectives of veterans with mild traumatic brain injury on community reintegration: Making sense of unplanned separation from service. Am J Orthopsychiatry. 2017;87(2):129-138. doi: 10.1037/ort0000253.

  PMID: 28206800 RESULT

Related Links

• Libin, Scholten et al. Perspectives of veterans with mild traumatic brain injury on community reintegration
• Libin, Scholten et al. Executive functioning in TBI from rehabilitation to social reintegration

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Social Adjustment

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Social Behavior; Behavior

Results Point of Contact

• Title: Dr.Joel Scholten
• Organization: DCVAMC

joel.scholten@va.gov

2027458000

Study Officials

• Joel Scholten, MD

  DCVAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: March 12, 2014
• Primary Completion: March 6, 2017
• Study Completion: March 31, 2018
• Last Updated: September 25, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)