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Clinical Trials/NCT03777020
NCT03777020
Completed
Not Applicable

Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD

University of Maryland, Baltimore1 site in 1 country60 target enrollmentAugust 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
University of Maryland, Baltimore
Enrollment
60
Locations
1
Primary Endpoint
Post Traumatic Stress Symptom Severity
Status
Completed
Last Updated
last year

Overview

Brief Summary

Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1 of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial functioning. PTSD symptom severity (PTSDSS) is significantly correlated with stress and psychosocial consequences of inability to regulate emotions, control impulsive behaviors, and function within family and society. Alarming veteran PTSD rates and its insidious effects demand empirically validated treatment programs. More than a million veterans receive new diagnoses of each year. VA PTSD therapy programs reach only 1% of veterans. Nearly 35% of veterans do not respond to widely used psychotherapy and pharmacotherapy treatments. Training a service dog (SD) is a novel rehabilitative animal-assisted intervention that shows promise in other populations. This project evaluates the efficacy of a service dog training program (SDTP) as an alternative and adjunctive treatment and rehabilitative option for veterans with PTSD.

Detailed Description

Veterans with PTSD attend 8 weekly sessions of either training a service dog or learning about how to train a dog at the Warrior Canine Connection facility in Boyds MD. They complete questionnaires prior to the start of the program and at the midpoint (after 4 sessions) and end of the program (after 8 sessions). Participants also wear a monitor to record heart rate variability during the 1st, 4th, and 8th sessions and provide saliva samples at these same times.

Registry
clinicaltrials.gov
Start Date
August 22, 2019
End Date
February 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erika Friedmann

Professor

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Excluded from the Warrior Canine Connection Service Dog Training Program. Their criteria are:
  • fear of dogs;
  • allergy to pet dander;
  • active substance abuse;
  • active psychosis, or
  • history of animal abuse
  • Excluded by the WCC from participation in their Service Dog Training Program because they have:
  • fear of dogs; allergy to pet dander; active substance abuse; active psychosis, history of animal abuse or physically unable to complete tasks required to train dogs

Outcomes

Primary Outcomes

Post Traumatic Stress Symptom Severity

Time Frame: Baseline, 8 weeks

Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)

Secondary Outcomes

  • Stress Biomarkers: Alpha Amylase(Baseline, 8 weeks)
  • Stress Biomarker Markers:Cortisol(Baseline, 8 weeks)
  • Stress Biomarkers: HRV(baseline, 8 weeks)
  • Psychosocial Health: Resilience(Baseline, 8 weeks)
  • Psychosocial Health: Relationship With Friends and Family(Baseline, 8 weeks)
  • Stress Biomarkers: IgA(Baseline, 8 weeks)
  • Psychosocial Health: Quality of Individual's Relationships(Baseline, 8 weeks)
  • Psychosocial Health: Satisfaction With Social Activities(Baseline, 8 weeks)
  • Psychosocial Health: Companionship(Baseline, 8 weeks)
  • Psychosocial Health: Anxiety(baseline, 8 weeks)
  • Stress Marker: Perceived Stress(Baseline, 8 weeks)
  • Psychosocial Health: Positive Affect(Baseline, 8 weeks)
  • Psychosocial Health: Health Related Quality of Life(Baseline, 8 weeks)
  • Psychosocial Health:Depression(baseline, 8 weeks)
  • Psychosocial Health: Suicidal Ideation(Baseline, 8 weeks)

Study Sites (1)

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