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

NCT05900479 | Active Not Recruiting DMC

• 2 other identifiers: STUDY00002088R01HD106413
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Combat Stress Disorders; Animal-Human Bonding

Outcome Measures

Primary Outcomes (1)

• PTSD Severity and symptoms via self-report

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

  8 months

Secondary Outcomes (3)

• PTSD Severity and symptoms via blinded clinician rating

  8 months

• Depression

  8 months

• Anxiety

  8 months

Study Arms (2)

PTSD Service Dog

EXPERIMENTAL

Other: PTSD Service Dog

Usual Care

NO INTERVENTION

Interventions

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.

Also known as: PTSD Assistance Dog, Psychiatric Service Dog

PTSD Service Dog

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders; Human-Animal Bond

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Human-Animal Interaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research, Professor

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)