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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Traumatic Brain Injuries

Intervention / Treatment
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* Behavioral: Problem-Solving Training (PST)
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Problem-Solving Training<br>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)<br>* Training in problem-solving skills to be applied to military caregiver problems.<br>|
| Sham Comparator: Attention Control<br>Attention/social contact control. Health education (non-skill focused). | Behavioral: Attention Control<br>* Social contact control (health education/no skill training)<br>* Other names: Social contact control;|

What is the study measuring?
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Primary Outcome Measures

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