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

NCT ID: NCT05900479

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2028-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PTSD Service Dog

Group Type: EXPERIMENTAL

PTSD Service Dog

Intervention Type: 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.

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PTSD Service Dog

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.

Intervention Type: OTHER

Other Intervention Names

PTSD Assistance Dog; Psychiatric Service Dog

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Maggie O'Haire

Associate Dean for Research, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

R01HD106413

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002088

Identifier Type: -

Identifier Source: org_study_id