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Enrolling by invitation NCT06723834

Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD

No phase Interventional Stress Disorders, Post-Traumatic PTSD Animal-Human Bonding Combat Stress Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychiatric Service Dog, Prolonged Exposure Therapy.
Who it may be relevant to
Registry conditions: Stress Disorders, Post-Traumatic, PTSD, Animal-Human Bonding, Combat Stress Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Psychiatric Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD: A Randomized Clinical Trial

Overview

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.

Interventions

  • Other Psychiatric Service Dog
    Partnership with a trained service dog for PTSD.
  • Behavioral Prolonged Exposure Therapy
    12 weeks of Prolonged Exposure once per week.

Primary outcome measures

  • PTSD Symptom Severity (Self-report) [Time frame: 3 months after start of PE]
Secondary outcome measures (7)
  • PTSD Symptom Severity (Clinician-assessed) [Time frame: 3 months after start of PE]
  • PTSD Diagnosis [Time frame: 3 months after start of PE]
  • Depression [Time frame: 3 months after start of PE]
  • Anxiety [Time frame: 3 months after start of PE]
  • Emotional affect [Time frame: 3 months after start of PE]
  • Satisfaction with life [Time frame: 3 months after start of PE]
  • Mental health [Time frame: 3 months after start of PE]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Arizona — Tucson

Identifiers

NCT: NCT06723834 · HT9425-24-1-0178 · CDMRP-PR230987

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗