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

Not Applicable

Completed

• Conditions: Traumatic Brain Injuries
• Interventions: Behavioral: Attention Control; Behavioral: Problem-Solving Training (PST)

• Registration Number: NCT02215187
• Lead Sponsor: University of Alabama at Birmingham

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Control	Attention Control	Attention/social contact control. Health education (non-skill focused).
Problem-Solving Training	Problem-Solving Training (PST)	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.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	Change from baseline in PHQ-9 scores at post-program (3-months follow-up)

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States