CONcussion Treatment After Combat Trauma (CONTACT)
CONTACT
The Effect of Telephone Follow up on Outcome for Service Members With Mild TBI/PTSD
1 other identifier
interventional
366
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 30, 2011
CompletedFirst Posted
Study publicly available on registry
July 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 4, 2016
March 1, 2016
3.3 years
June 30, 2011
March 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Effects on functioning, quality of life, pain, sleep, depression, posttraumatic stress, resilience, work activity, and health services usage.
6 months
Effect of ISTS in demographic subgroups
12 months
Satisfaction with ISTS by participants and significant others
12 months
Study Arms (2)
Individualized Scheduled Telephone Support (ISTS)
EXPERIMENTALISTS 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)
OTHERUC 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Active military or National Guard/Reserve status
- Enrollment within 2 years of return from Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) theater and subsequent operations.
- 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))
- Has access to a telephone.
You may not qualify if:
- Moderate or severe TBI (Glasgow Coma Scale \< 13) requiring hospitalization
- Active psychotic disorder (including schizophrenia and schizoaffective disorder), severe depression with active suicidal ideation at TBI clinic visit, or current bipolar disorder by history.
- Enrollment into intensive treatment at TBI programs at Madigan or Womack Army Medical Center
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Duke University
Durham, North Carolina, 27710, United States
Womack Army Medical Center
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
Related Publications (1)
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.
PMID: 27579992DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen R Bell, MD
University of Washington
- STUDY DIRECTOR
Nancy Temkin, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2011
First Posted
July 4, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2014
Study Completion
February 1, 2015
Last Updated
March 4, 2016
Record last verified: 2016-03