Clinical trial NCT02215187: Telehealth-Education-Based Program for Military Caregivers of Injured Service Members With Head Injuries
Official title: Cognitive Behavioral Therapy (CBT) for Caregivers of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Service Members With Combat-Related Traumatic Brain Injuries (TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injuries
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 213
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Change from baseline in PHQ-9 scores at post-program (3-months follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Dreer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: