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

Traumatic Brain Injuries Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215187
• Other study ID #: #000435754
• Secondary ID: H133G110275
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Problem-Solving Training (PST)
Training in problem-solving skills to be applied to military caregiver problems.
• Attention Control
Social contact control (health education/no skill training)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9		Change from baseline in PHQ-9 scores at post-program (3-months follow-up)