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

NCT02215187 | Completed DMC

• 2 other identifiers: #000435754H133G110275
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9

  Change from baseline in PHQ-9 scores at post-program (3-months follow-up)

Study Arms (2)

Problem-Solving Training

EXPERIMENTAL

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.

Behavioral: Problem-Solving Training (PST)

Attention Control

SHAM COMPARATOR

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

Behavioral: Attention Control

Interventions

Problem-Solving Training (PST) BEHAVIORAL

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

Problem-Solving Training

Attention Control BEHAVIORAL

Social contact control (health education/no skill training)

Also known as: Social contact control

Attention Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Laura Dreer, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: August 13, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

US (1)