Clinical trial NCT01387490: CONcussion Treatment After Combat Trauma (CONTACT)
Official title: The Effect of Telephone Follow up on Outcome for Service Members With Mild TBI/PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Mild Traumatic Brain Injury
Telephone counseling
Lead sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2011-07-04
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rivermead Post Concussion Symptoms Questionnaire
timeFrame: 6 months
measure: Brief Symptom Inventory - 18 Global Severity Index
timeFrame: 6 months
Secondary outcomes:
measure: Effects on functioning, quality of life, pain, sleep, depression, posttraumatic stress, resilience, work activity, and health services usage.
timeFrame: 6 months
measure: Effect of ISTS in demographic subgroups
timeFrame: 12 months
measure: Satisfaction with ISTS by participants and significant others
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
city: Fort Lewis
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kathleen R Bell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Nancy Temkin, PhD
role: STUDY_DIRECTOR
References:
citation: 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.