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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Scheduled Telephone Support (ISTS) | Experimental | 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) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Scheduled Telephone Support (ISTS) | Behavioral | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen R Bell, MD | University of Washington | Principal Investigator |
| Nancy Temkin, PhD | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States | ||
| Womack Army Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27579992 | Derived | Bell KR, Fann JR, Brockway JA, Cole WR, Bush NE, Dikmen S, Hart T, Lang AJ, Grant G, Gahm G, Reger MA, St De Lore J, Machamer J, Ernstrom K, Raman R, Jain S, Stein MB, Temkin N. Telephone Problem Solving for Service Members with Mild Traumatic Brain Injury: A Randomized, Clinical Trial. J Neurotrauma. 2017 Jan 15;34(2):313-321. doi: 10.1089/neu.2016.4444. Epub 2016 Oct 13. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Usual Care (UC) | Other | 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. |
|
| 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 |
| Fort Bragg |
| North Carolina |
| 28307 |
| United States |
| Madigan Army Medical Center | Fort Lewis | Washington | 98431 | United States |
| University of Washington | Seattle | Washington | 91985 | United States |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |