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Clinical Trials/NCT03245814
NCT03245814
Completed
Not Applicable

Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD

University of Arizona1 site in 1 country170 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
University of Arizona
Enrollment
170
Locations
1
Primary Endpoint
PTSD Severity and Symptoms Via Self-report
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).

Detailed Description

The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations. The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation. The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention. The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
June 4, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maggie O'Haire

Professor

University of Arizona

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

PTSD Severity and Symptoms Via Self-report

Time Frame: 3 months

Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome.

PTSD Severity and Symptoms Via Clinician Rating

Time Frame: 3 months

Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome.

Depression

Time Frame: 3 months

Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.

Anxiety

Time Frame: 3 months

Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.

Secondary Outcomes

  • Psychological Well-being(3 months)
  • Social Isolation(3 months)
  • Companionship(3 months)
  • Ability to Participate in Social Activities(3 months)
  • Mental Health Quality of Life(3 months)
  • Life Satisfaction(3 months)
  • Resilience(3 months)
  • Anger(3 months)
  • Daily Socio-emotional Experiences(3 months)

Study Sites (1)

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