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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

Tracking Information
First Submitted Date  ICMJE June 24, 2014
First Posted Date  ICMJE August 13, 2014
Last Update Posted Date October 22, 2019
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telehealth-Education-Based Program for Military Caregivers of Injured Service Members With Head Injuries
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injuries
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2014)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02215187
Other Study ID Numbers  ICMJE #000435754
H133G110275 ( Other Grant/Funding Number: NIDRR/H133G110275 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laura E. Dreer, PhD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Dreer, Ph.D. University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP