CONcussion Treatment After Combat Trauma (CONTACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01387490
First received: June 30, 2011
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

This study compares the effects of Individualized Scheduled Telephone Support (ISTS) and Usual Care (UC) for service members with Mild Traumatic Brain Injury (mTBI). A total of 400 service members will participate in this study. ISTS is a telephone intervention that provides injury-related education, training in problem solving, and focused behavioral strategies for problems (e.g. anxiety, depression) that commonly co-occur with MTBI. ISTS also includes access to usual care and web-based and printed educational material. The 12 phone calls included in ISTS will be administered over a 6-month period. UC is the usual care provided to service members attending the Traumatic Brain Injury (TBI) Clinics at Madigan Army Medical Center and Womack Army Medical Center, plus web-based education and 12 mailings of educational materials over a 6-month period. Subjects will complete major assessments at study entry and then 6 months and 12 months later. The primary aim of the study is to compare the effects of ISTS and UC on post-concussive symptoms and emotional distress at the 6-month assessment. The investigators predict that participants who receive ISTS will report lower levels of post-concussive symptoms and emotional distress at the 6-month assessment. Secondary aims include comparing the longer term effects of ISTS and UC at the 12-month assessment, as well as comparing their effects on other outcomes such as post-traumatic stress symptoms, quality of life, resilience, and work activity.


Condition Intervention
Traumatic Brain Injury
Behavioral: Individualized Scheduled Telephone Support (ISTS)
Other: Usual Care (UC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Telephone Follow up on Outcome for Service Members With Mild TBI/PTSD

Resource links provided by NLM:


Further study details as provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:

Primary Outcome Measures:
  • Rivermead Post Concussion Symptoms Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    16-item self-report measure of symptoms that commonly occur following head injury

  • Brief Symptom Inventory - 18 Global Severity Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    18-item self-report measure of emotional distress; the Global Severity Index includes all items which capture anxious, depressive, and somatic symptoms


Secondary Outcome Measures:
  • Effects on functioning, quality of life, pain, sleep, depression, posttraumatic stress, resilience, work activity, and health services usage. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison of effects using the EuroQol, Patient Health Questionnaire-9 (PHQ-9), PTSD Checklist- Pittsburgh Sleep Quality Index (PSQI), 10-item Connor-Davidson Resilience Scale (CD-RISC), the Brief Inventory for Functioning Evaluation (B-IFE), and Cornell Services Index (CSI).

  • Effect of ISTS in demographic subgroups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Attention to minority versus non-minority racial and ethnic populations, and active duty military versus National Guard/Reserve populations.

  • Satisfaction with ISTS by participants and significant others [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of satisfaction with ISTS using Client Satisfaction Questionnaire.


Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individualized Scheduled Telephone Support (ISTS)
ISTS is a telephone intervention that provides injury-related education, training in problem solving, and focused behavioral strategies for problems (e.g., anxiety, depression) that commonly co-occur with Mild Traumatic Brain Injury (MTBI). ISTS also includes access to usual care and web-based and printed educational material. The 12 phone calls included in ISTS will be administered over a 6-month period.
Behavioral: Individualized Scheduled Telephone Support (ISTS)
ISTS is a telephone intervention that provides injury-related education, training in problem solving, and focused behavioral strategies for problems (e.g., anxiety, depression) that commonly co-occur with Mild Traumatic Brain Injury (MTBI). ISTS also includes access to usual care and web-based and printed educational material. The 12 phone calls included in ISTS will be administered over a 6-month period.
Usual Care (UC)
UC is the usual care provided to service members attending the Traumatic Brain Injury (TBI) Clinics at Madigan Army Medical Center and Womack Army Medical Center, plus web-based education and 12 mailings of educational materials over a 6-month period.
Other: Usual Care (UC)
UC is the usual care provided to service members attending the Traumatic Brain Injury (TBI) Clinics at Madigan Army Medical Center and Womack Army Medical Center, plus web-based education and 12 mailings of educational materials over a 6-month period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Active military or National Guard/Reserve status
  2. Enrollment within 2 years of return from Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) theater and subsequent operations.
  3. Positive response to screening at post-deployment examination and positive response to questions 1,2, or 6 on the "2 + 10 Traumatic Brain Injury (TBI) Screening Questionnaire" or positive response to questions 1c, 4,5, or 6 on the Military Acute Concussion Evaluation (which corresponds to the critical sections of the Centers for Disease Control operational definition of Mild Traumatic Brain Injury (MTBI))
  4. Has access to a telephone.

Exclusion Criteria:

  1. Moderate or severe TBI (Glasgow Coma Scale < 13) requiring hospitalization
  2. Active psychotic disorder (including schizophrenia and schizoaffective disorder), severe depression with active suicidal ideation at TBI clinic visit, or current bipolar disorder by history.
  3. Enrollment into intensive treatment at TBI programs at Madigan or Womack Army Medical Center
  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: NCT01387490

Locations
United States, North Carolina
Duke University Active, not recruiting
Durham, North Carolina, United States, 27710
Womack Army Medical Center Recruiting
Fort Bragg, North Carolina, United States, 28307
Contact: Danielle Feldman, MPH    910-643-2522    Danielle.H.Feldman@amedd.army.mil   
Principal Investigator: Wesley Cole, PhD         
United States, Washington
Madigan Army Medical Center Recruiting
Fort Lewis, Washington, United States, 98431
Contact: Elissa Thomas, LPN       elissa.k.thomas@us.army.mil   
Principal Investigator: Gregory P Gahm, PhD         
University of Washington Active, not recruiting
Seattle, Washington, United States, 91985
Sponsors and Collaborators
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Kathleen R Bell, MD University of Washington
  More Information

No publications provided

Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier: NCT01387490     History of Changes
Other Study ID Numbers: INTRuST-CONTACT
Study First Received: June 30, 2011
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:
Mild Traumatic Brain Injury
Telephone counseling

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014