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

• ClinicalTrials.gov Identifier: NCT02215187
• Recruitment Status: Active, not recruiting
• First Posted: August 13, 2014
• Last Update Posted: October 22, 2019
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Laura E. Dreer, PhD, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: June 24, 2014
• First Posted Date: August 13, 2014
• Last Update Posted Date: October 22, 2019
• Study Start Date: July 2013
• Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 11, 2014): Patient Health Questionnaire-9 [ Time Frame: Change from baseline in PHQ-9 scores at post-program (3-months follow-up) ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Traumatic Brain Injuries

Intervention

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

Study Arms

• Experimental: 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.
  Intervention: Behavioral: Problem-Solving Training (PST)
• Sham Comparator: Attention Control
  Attention/social contact control. Health education (non-skill focused).
  Intervention: Behavioral: Attention Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 11, 2014): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2020
• Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02215187
• Other Study ID Numbers: #000435754; H133G110275 ( Other Grant/Funding Number: NIDRR/H133G110275 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Laura E. Dreer, PhD, University of Alabama at Birmingham
• Study Sponsor: University of Alabama at Birmingham
• Collaborators: Not Provided

Investigators

• Principal Investigator: Laura Dreer, Ph.D.; University of Alabama at Birmingham

• PRS Account: University of Alabama at Birmingham
• Verification Date: October 2019