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Clinical Trials/NCT02215187
NCT02215187
Completed
Not Applicable

Cognitive Behavioral Therapy (CBT) for Caregivers of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Service Members With Combat-Related Traumatic Brain Injuries (TBI)

University of Alabama at Birmingham1 site in 1 country213 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injuries
Sponsor
University of Alabama at Birmingham
Enrollment
213
Locations
1
Primary Endpoint
Patient Health Questionnaire-9
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The primary purpose of this research is to evaluate the impact of a telehealth-based, cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult informal military family/friend caregivers of OIF/OEF service members with a deployment-related TBI.

Detailed Description

Traumatic brain injury (TBI) has gained increasing attention in American society as it is now considered the "signature injury" of the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) campaigns. The chronic changes that often occur in the wake of TBI along with possible physical injuries may run a chronic, unremitting course, imposing great strain and distress upon family members who often assume a caregiver role with little preparation and no formal training for these wounded service members as they reintegrate back into civilian life post-deployment. Unfortunately, research has not adequately addressed the unique long-term needs of informal military caregivers of deployed service members with TBI (i.e., family members/close friends).

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura E. Dreer, PhD

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 19 years old
  • Meets study project definition of a military caregiver
  • Documentation or determination of an OIF/OEF deployment related TBI
  • Service member will have presented to a Veterans Administration Medical Center (VAMC) or military medical center
  • English-speaking
  • Has access to a telephone for the administration of measures and/or intervention calls
  • Has no significant cognitive or communication problems that might significantly interfere with adequately understanding information or talking on the telephone which will be determined by the clinical judgment of the person consenting the participant.

Exclusion Criteria

  • Has a life-threatening or other serious disease that impacts the ability to participate for the duration of the project
  • No determination or documentation of a deployment-related TBI related to OIF/OEF for the injured service member
  • Has a severe hearing impairment that impedes communication and standardized implementation of the intervention and telephone follow-up
  • Formal caregiver
  • Caregiver does not want to participate

Outcomes

Primary Outcomes

Patient Health Questionnaire-9

Time Frame: Change from baseline in PHQ-9 scores at post-program (3-months follow-up)

Study Sites (1)

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