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Clinical Trials/NCT05900479
NCT05900479
Active, Not Recruiting
N/A

Multi-site, Longitudinal Trial Evaluating the Efficacy, Mechanisms, and Moderators of Service Dogs for Military Veterans With PTSD

University of Arizona1 site in 1 country150 target enrollmentSeptember 15, 2023

Overview

Phase
N/A
Intervention
PTSD Service Dog
Conditions
Stress Disorders, Post-Traumatic
Sponsor
University of Arizona
Enrollment
150
Locations
1
Primary Endpoint
PTSD Severity and symptoms via self-report
Status
Active, Not Recruiting
Last Updated
2 months ago

Overview

Brief Summary

Posttraumatic stress disorder (PTSD) among military Veterans is a critical public health concern. Veteran suicide rates exceed those of the general population, with the disorder creating a mental health challenge that is costly and debilitating. The majority of Veterans with PTSD also have comorbid mental health diagnoses, such as generalized anxiety disorder, substance abuse disorder, and major depression. The treatment of Veteran PTSD and comorbid disorders represents an important therapeutic and rehabilitation problem. The disorder is complex and difficult to treat, with high treatment dropout and nonresponse rates spurring some Veterans to seek complementary integrative health strategies. One promising complementary strategy is the provision of a trained service dog. Initial evidence across multiple research groups highlights service dogs as a promising complement to evidence-based practices that can offer short-term improvements. However, the long-term effectiveness, mechanisms of action, and moderators of efficacy remain largely unknown. Thus, the overarching objective of this proposal is to understand how, why, and for whom PTSD service dogs are most effective.

To address this objective, the present project will assess the longitudinal efficacy and dose-response curve of service dogs for Veteran PTSD symptomology and psychosocial functioning. The research design will consist of a two-arm, randomized clinical trial (RCT) with longitudinal assessments over a period of 15 months. Results are expected to elucidate the clinical impact of service dogs for military Veterans with PTSD, as well as the biobehavioral mechanisms of action and characteristics that moderate efficacy. These outcomes will support the long-term goal of accelerating complementary and integrative health interventions, through optimized and evidence-based service dog interventions. As such, this project will further advance the scientific understanding of human-animal interactions for psychosocial health.

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
August 1, 2028
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maggie O'Haire

Associate Dean for Research, Professor

University of Arizona

Eligibility Criteria

Inclusion Criteria

  • Applied for and approved to receive a psychiatric service dog from Canine Companions, K9s For Warriors, or America's VetDogs
  • First service dog (not a successor service dog)
  • Military service
  • Honorable discharge or current honorable service
  • Diagnosis of PTSD
  • No conviction of any crimes against animals
  • Able to follow the approved study timeline for randomization

Exclusion Criteria

  • Not provided

Arms & Interventions

PTSD Service Dog

Intervention: PTSD Service Dog

Usual Care

Outcomes

Primary Outcomes

PTSD Severity and symptoms via self-report

Time Frame: 8 months

Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5, Range 0-80, Lower scores indicate a better outcome)

Secondary Outcomes

  • Depression(8 months)
  • Anxiety(8 months)
  • PTSD Severity and symptoms via blinded clinician rating(8 months)

Study Sites (1)

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