CONcussion Treatment After Combat Trauma (CONTACT)
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | February 2015 |
The Effect of Telephone Follow up on Outcome for Service Members With Mild TBI/PTSD
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.
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.
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
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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