Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD

NCT ID: NCT06723834

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-23
• Study Completion Date: 2030-09-30

Brief Summary

This study investigates the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy. We will learn whether Service Dog partnership in combination with Prolonged Exposure Therapy treatment can help Veterans with PTSD.

Detailed Description

Posttraumatic stress disorder (PTSD) is common among military Service Members and Veterans (hereafter, "Veterans"). Symptoms of flashbacks, nightmares, and panic attacks can have devastating impacts on Veterans and their families. Suicide and suicidality are also closely linked to PTSD, and the rate of death by suicide among Veterans is nearly double that of the civilian population. PTSD is also difficult to treat. Many Veterans either do not seek treatment at all, or if they start treatment, do not finish. Even if treatment is completed, many Veterans still suffer symptoms and even retain their PTSD diagnosis. There is a critical need to find ways to reduce dropout rates, thus improving the effectiveness of existing, gold-standard treatments and promoting positive outcomes for Veterans and their families.

In their search for effective treatments, some Veterans are turning to add-on interventions for PTSD, such as partnership with a Service Dog. Under the Americans with Disabilities Act (ADA), service dogs are defined as dogs trained to perform specific tasks to mitigate a disability. Service dogs for PTSD are trained in tasks including detecting and alerting to signs of distress to interrupt anxiety and panic attacks 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, Veterans with PTSD have the legal right to be accompanied by their service dog in public places such as grocery stores, workplaces, and schools. In this study, service dogs will be sourced from participating service dog organizations.

Service Dogs for Veterans are not only increasingly in demand, but a growing body of evidence demonstrates that Service Dogs can significantly improve the lives of Veterans with PTSD. Unfortunately, there is currently no research exploring whether adding a Service Dog will impact the effectiveness of evidence-based PTSD treatments, such as Prolonged Exposure Therapy (PE). Prolonged Exposure Therapy is a gold-standard, frontline treatment for PTSD that is highly effective, but has high rates of dropout.

PE teaches individuals with PTSD to gradually approach trauma-related memories, feelings, and situations that they have been avoiding since their trauma. By confronting these challenges, participants can decrease their PTSD symptoms. PE treatment typically last 12 weeks for 75-90 minutes, once per week.

Initial findings suggest that Service Dogs may help Veterans stay in Prolonged Exposure Therapy resulting in better treatment outcomes. However, some mental health professionals worry that Service Dogs may in fact interfere with treatment goals. This novel study is designed to help understand the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy.

Conditions

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

Study Design

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

Study Groups

PTSD Service Dog + Prolonged Exposure Therapy

Participants will receive 12 weeks of Prolonged Exposure once per week with the addition of a service dog

Group Type: EXPERIMENTAL

Psychiatric Service Dog

Intervention Type: OTHER

Partnership with a trained service dog for PTSD.

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

12 weeks of Prolonged Exposure once per week.

Prolonged Exposure Therapy Alone

Participants will receive 12 weeks of Prolonged Exposure once per week

Group Type: ACTIVE_COMPARATOR

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

12 weeks of Prolonged Exposure once per week.

Interventions

Psychiatric Service Dog

Partnership with a trained service dog for PTSD.

Intervention Type: OTHER

Prolonged Exposure Therapy

12 weeks of Prolonged Exposure once per week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Applied for and approved to receive a psychiatric service dog from a service dog organization participating in the study
• Diagnosis of PTSD on the CAPS-5-R

Exclusion Criteria

• Current service dog
• Current participation in Prolonged Exposure Therapy

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

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

CDMRP-PR230987

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HT9425-24-1-0178

Identifier Type: -

Identifier Source: org_study_id