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CONcussion Treatment After Combat Trauma (CONTACT) (CONTACT)

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individualized Scheduled Telephone Support (ISTS)
Usual Care (UC)
Sponsored by
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Mild Traumatic Brain Injury, Telephone counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke University
  • Womack Army Medical Center
  • Madigan Army Medical Center
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Individualized Scheduled Telephone Support (ISTS)

Usual Care (UC)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Rivermead Post Concussion Symptoms Questionnaire
16-item self-report measure of symptoms that commonly occur following head injury
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

Secondary Outcome Measures

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).
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.
Satisfaction with ISTS by participants and significant others
Evaluation of satisfaction with ISTS using Client Satisfaction Questionnaire.

Full Information

First Posted
June 30, 2011
Last Updated
March 2, 2016
Sponsor
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01387490
Brief Title
CONcussion Treatment After Combat Trauma (CONTACT)
Acronym
CONTACT
Official Title
The Effect of Telephone Follow up on Outcome for Service Members With Mild TBI/PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Mild Traumatic Brain Injury, Telephone counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized Scheduled Telephone Support (ISTS)
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care (UC)
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Individualized Scheduled Telephone Support (ISTS)
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Usual Care (UC)
Intervention 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.
Primary Outcome Measure Information:
Title
Rivermead Post Concussion Symptoms Questionnaire
Description
16-item self-report measure of symptoms that commonly occur following head injury
Time Frame
6 months
Title
Brief Symptom Inventory - 18 Global Severity Index
Description
18-item self-report measure of emotional distress; the Global Severity Index includes all items which capture anxious, depressive, and somatic symptoms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effects on functioning, quality of life, pain, sleep, depression, posttraumatic stress, resilience, work activity, and health services usage.
Description
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).
Time Frame
6 months
Title
Effect of ISTS in demographic subgroups
Description
Attention to minority versus non-minority racial and ethnic populations, and active duty military versus National Guard/Reserve populations.
Time Frame
12 months
Title
Satisfaction with ISTS by participants and significant others
Description
Evaluation of satisfaction with ISTS using Client Satisfaction Questionnaire.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen R Bell, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Temkin, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28307
Country
United States
Facility Name
Madigan Army Medical Center
City
Fort Lewis
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
91985
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27579992
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.
Results Reference
derived

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CONcussion Treatment After Combat Trauma (CONTACT)

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