CONcussion Treatment After Combat Trauma (CONTACT)

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Telephone Follow up on Outcome for Service Members With Mild TBI/PTSD

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Individualized Scheduled Telephone Support (ISTS)
* Other: Usual Care (UC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Scheduled Telephone Support (ISTS)<br>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)<br>* 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.<br>|
| Other: Usual Care (UC)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead Post Concussion Symptoms Questionnaire | 16-item self-report measure of symptoms that commonly occur following head injury | 6 months | 
| Brief Symptom Inventory - 18 Global Severity Index | 18-item self-report measure of emotional distress; the Global Severity Index includes all items which capture anxious, depressive, and somatic symptoms | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on functioning, quality of life, pain, sleep, depression, posttraumatic stress, resilience, work activity, and health services usage. | 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). | 6 months | 
| Effect of ISTS in demographic subgroups | Attention to minority versus non-minority racial and ethnic populations, and active duty military versus National Guard/Reserve populations. | 12 months | 
| Satisfaction with ISTS by participants and significant others | Evaluation of satisfaction with ISTS using Client Satisfaction Questionnaire. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Traumatic Brain Injury, Telephone counseling