Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD (SERVES+)

University of Arizona

Status: Begins enrollment in 5 months

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

Treatments: Other: Psychiatric Service Dog; Behavioral: Prolonged Exposure Therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06723834

CDMRP-PR230987 (Other Grant/Funding Number)

HT9425-24-1-0178

Details and patient eligibility

About

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.

Full 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 Assistance Dog International (ADI) accredited providers.

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Applied for and approved to receive a psychiatric service dog from Canine Companions or K9s For Warriors
• Diagnosis of PTSD on the CAPS-5-R

Exclusion criteria

• Current service dog
• Current participation in Prolonged Exposure Therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

PTSD Service Dog + Prolonged Exposure Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Prolonged Exposure Therapy

Other: Psychiatric Service Dog

Prolonged Exposure Therapy Alone

Active Comparator group

Description:

Participants will receive 12 weeks of Prolonged Exposure once per week

Treatment:

Behavioral: Prolonged Exposure Therapy