CONcussion Treatment After Combat Trauma (CONTACT)

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT01387490

Run by

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

People needed

366

Starts

2011-06-01

Expected to finish

2015-02-01

Last updated by the study team

2016-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Active military or National Guard/Reserve status
• Enrollment within 2 years of return from Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) theater and subsequent operations.
• 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))
• Has access to a telephone.

You may not qualify if…

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

Where it is running

• Duke University — Durham, North Carolina, United States
• Womack Army Medical Center — Fort Bragg, North Carolina, United States
• Madigan Army Medical Center — Fort Lewis, Washington, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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