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NCT Number: NCT05900479

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85719, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTSD Service Dog

Other

According to the Americans with Disabilities Act (ADA), a service dog is a dog that is trained to perform specific tasks to mitigate a disability. For PTSD service dogs, examples include detecting and alerting to physical signs of distress to interrupt anxiety and panic attacks, waking up Veterans from nightmares, and retrieving medication. In addition to trained tasks, service dogs live with the Veterans to provide emotional value as a source of comfort and companionship. Under the ADA guidance, PTSD service dogs have pubic access and are legally allowed to accompany their person in public places such as grocery stores, workplaces, and schools. In the proposed study, service dogs will be sourced from three national service dog providers, including K9s For Warriors, Canine Companions, and America's VetDogs. All three providers have an established track record of training and providing service dogs for PTSD, as well as collaborating with the investigative team in research.

Other names: PTSD Assistance Dog, Psychiatric Service Dog

Primary outcomes

  1. 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

  1. PTSD Severity and symptoms via blinded clinician rating

    Time frame: 8 months

    Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5-R, Range 0-200, Lower scores indicate a better outcome)

  2. Depression

    Time frame: 8 months

    Patient Health Questionnaire (PHQ-9, Range 1-27, Lower scores indicate a better outcome)

  3. Anxiety

    Time frame: 8 months

    Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety 8a (Raw Score Range 8-40, Lower scores indicate a better outcome)

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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