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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215187
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Laura E. Dreer, PhD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injuries Behavioral: Problem-Solving Training (PST) Behavioral: Attention Control Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : July 2013
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Problem-Solving Training (PST)
Training in problem-solving skills to be applied to military caregiver problems.

Sham Comparator: Attention Control
Attention/social contact control. Health education (non-skill focused).
Behavioral: Attention Control
Social contact control (health education/no skill training)
Other Name: Social contact control




Primary Outcome Measures :
  1. Patient Health Questionnaire-9 [ Time Frame: Change from baseline in PHQ-9 scores at post-program (3-months follow-up) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215187


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35243
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Laura Dreer, Ph.D. University of Alabama at Birmingham
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Responsible Party: Laura E. Dreer, PhD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02215187    
Other Study ID Numbers: #000435754
H133G110275 ( Other Grant/Funding Number: NIDRR/H133G110275 )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System