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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
University of Alabama at Birmingham

Study Contact

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.