Telehealth-Education-Based Program for Military Caregivers of Injured Service Members With Head Injuries

February 28, 2024 updated by: Laura E. Dreer, PhD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Problem-Solving Training
PST is a cognitive-behavioral intervention. Delivery of the PST + usual care condition will be administered to caregivers over the course of 6 one-hour per week, telephone calls/sessions that will entail education related to problem-solving skills/problem-solving model and application to caregiving and managing caregiver related problems.
Behavioral: Problem-Solving Training (PST)
Training in problem-solving skills to be applied to military caregiver problems.
Sham Comparator: Attention Control
Attention/social contact control. Health education (non-skill focused).
Behavioral: Attention Control
Social contact control (health education/no skill training)
Other Names:
  • Social contact control

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Laura Dreer, Ph.D., University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimated)

August 13, 2014

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #000435754
  • H133G110275 (Other Grant/Funding Number: NIDRR/H133G110275)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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