CONcussion Treatment After Combat Trauma (CONTACT)

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Other: Usual Care (UC); Behavioral: Individualized Scheduled Telephone Support (ISTS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01387490

INTRuST-CONTACT

Details and patient eligibility

About

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.

Enrollment: 366 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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366 participants in 2 patient groups

Individualized Scheduled Telephone Support (ISTS)

Experimental group

Description:

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.

Treatment:

Behavioral: Individualized Scheduled Telephone Support (ISTS)

Usual Care (UC)

Other group

Description:

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.

Treatment:

Other: Usual Care (UC)