Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

CONcussion Treatment After Combat Trauma (CONTACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01387490
First received: June 30, 2011
Last updated: October 25, 2013
Last verified: October 2013

June 30, 2011
October 25, 2013
June 2011
April 2014   (final data collection date for primary outcome measure)
  • Rivermead Post Concussion Symptoms Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    16-item self-report measure of symptoms that commonly occur following head injury
  • Brief Symptom Inventory - 18 Global Severity Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    18-item self-report measure of emotional distress; the Global Severity Index includes all items which capture anxious, depressive, and somatic symptoms
Same as current
Complete list of historical versions of study NCT01387490 on ClinicalTrials.gov Archive Site
  • Effects on functioning, quality of life, pain, sleep, depression, posttraumatic stress, resilience, work activity, and health services usage. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).
  • Effect of ISTS in demographic subgroups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Attention to minority versus non-minority racial and ethnic populations, and active duty military versus National Guard/Reserve populations.
  • Satisfaction with ISTS by participants and significant others [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of satisfaction with ISTS using Client Satisfaction Questionnaire.
Not Provided
Not Provided
Not Provided
 
CONcussion Treatment After Combat Trauma (CONTACT)
The Effect of Telephone Follow up on Outcome for Service Members With Mild TBI/PTSD

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
  • 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.
  • Experimental: 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.
    Intervention: Behavioral: Individualized Scheduled Telephone Support (ISTS)
  • 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.
    Intervention: Other: Usual Care (UC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
September 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01387490
INTRuST-CONTACT
Yes
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Principal Investigator: Kathleen R Bell, MD University of Washington
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP