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

Primary Purpose

Traumatic Brain Injuries

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem-Solving Training (PST)
Attention Control
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injuries

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Problem-Solving Training

Attention Control

Arm Description

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.

Attention/social contact control. Health education (non-skill focused).

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9

Secondary Outcome Measures

Full Information

First Posted
June 24, 2014
Last Updated
February 10, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02215187
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Problem-Solving Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
Sham Comparator
Arm Description
Attention/social contact control. Health education (non-skill focused).
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Training (PST)
Intervention Description
Training in problem-solving skills to be applied to military caregiver problems.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Other Intervention Name(s)
Social contact control
Intervention Description
Social contact control (health education/no skill training)
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Time Frame
Change from baseline in PHQ-9 scores at post-program (3-months follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Dreer, Ph.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States

12. IPD Sharing Statement

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

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