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

NCT ID: NCT02215187

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-12-31

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).

Conditions

Traumatic Brain Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Problem-Solving Training (PST)

Intervention Type: BEHAVIORAL

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

Attention Control

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

Group Type: SHAM_COMPARATOR

Attention Control

Intervention Type: BEHAVIORAL

Social contact control (health education/no skill training)

Interventions

Problem-Solving Training (PST)

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

Intervention Type: BEHAVIORAL

Attention Control

Social contact control (health education/no skill training)

Intervention Type: BEHAVIORAL

Other Intervention Names

Social contact control

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Laura E. Dreer, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Dreer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

H133G110275

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

#000435754

Identifier Type: -

Identifier Source: org_study_id