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

The University of Alabama at Birmingham

Status: Completed

Conditions: Traumatic Brain Injuries

Treatments: Behavioral: Problem-Solving Training (PST); Behavioral: Attention Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02215187

#000435754

H133G110275 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 213 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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213 participants in 2 patient groups

Problem-Solving Training

Experimental group

Description:

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.

Treatment:

Behavioral: Problem-Solving Training (PST)

Attention Control

Sham Comparator group

Description:

Attention/social contact control. Health education (non-skill focused).

Treatment:

Behavioral: Attention Control