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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02215187
Enrollment
213
Registered
2014-08-13
Start date
2013-07-31
Completion date
2016-12-31
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injuries

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).

Interventions

Training in problem-solving skills to be applied to military caregiver problems.

BEHAVIORALAttention Control

Social contact control (health education/no skill training)

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026