NCT01387490

CONcussion Treatment After Combat Trauma (CONTACT)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Individualized Scheduled Telephone Support (ISTS)	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.
OTHER	Usual Care (UC)	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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-10-01
• Completion: 2015-02-01
• First posted: 2011-07-04
• Last updated: 2016-03-04

Locations

4 sites across 1 country: United States