CONcussion Treatment After Combat Trauma (CONTACT)

Traumatic Brain Injury Clinical Trial

— CONTACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387490
• Other study ID #: INTRuST-CONTACT
• Status: Completed
• Phase: N/A
• First received: June 30, 2011
• Last updated: March 2, 2016
• Start date: June 2011
• Est. completion date: February 2015

Study information

• Verified date: March 2016
• Source: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Womack Army Medical Center	Fort Bragg	North Carolina
United States	Madigan Army Medical Center	Fort Lewis	Washington
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rivermead Post Concussion Symptoms Questionnaire	16-item self-report measure of symptoms that commonly occur following head injury	6 months	No
Primary	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	No
Secondary	Effects on functioning, quality of life, pain, sleep, depression, posttraumatic stress, resilience, work activity, and health services usage.	Comparison of effects using the EuroQol, Patient Health Questionnaire-9 (PHQ-9), PTSD Checklist- Pittsburgh Sleep Quality Index (PSQI), 10-item Connor-Davidson Resilience Scale (CD-RISC), the Brief Inventory for Functioning Evaluation (B-IFE), and Cornell Services Index (CSI).	6 months	No
Secondary	Effect of ISTS in demographic subgroups	Attention to minority versus non-minority racial and ethnic populations, and active duty military versus National Guard/Reserve populations.	12 months	No
Secondary	Satisfaction with ISTS by participants and significant others	Evaluation of satisfaction with ISTS using Client Satisfaction Questionnaire.	12 months	No