CONcussion Treatment After Combat Trauma (CONTACT)
| Tracking Information | |||||
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| First Received Date ICMJE | June 30, 2011 | ||||
| Last Updated Date | April 24, 2013 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01387490 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | CONcussion Treatment After Combat Trauma (CONTACT) | ||||
| Official Title ICMJE | The Effect of Telephone Follow up on Outcome for Service Members With Mild TBI/PTSD | ||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Traumatic Brain Injury | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01387490 | ||||
| Other Study ID Numbers ICMJE | INTRuST-CONTACT | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium | ||||
| Study Sponsor ICMJE | INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium | ||||
| Collaborators ICMJE | U.S. Army Medical Research and Materiel Command | ||||
| Investigators ICMJE |
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| Information Provided By | INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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