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Enrolling by Invitation

NCT Number: NCT06723834

Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychiatric Service Dog

Other

Partnership with a trained service dog for PTSD.

Prolonged Exposure Therapy

Behavioral

12 weeks of Prolonged Exposure once per week.

Primary outcomes

  1. PTSD Symptom Severity (Self-report)

    Time frame: 3 months after start of PE

    PTSD Checklist for DSM-5 (PCL-5) Total Score; range 0-80; higher scores indicate worse outcome.

Secondary outcomes

  1. PTSD Symptom Severity (Clinician-assessed)

    Time frame: 3 months after start of PE

    Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Total Score; range 0-200; higher scores indicate worse outcome.

  2. PTSD Diagnosis

    Time frame: 3 months after start of PE

    Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Diagnosis; binary

  3. Depression

    Time frame: 3 months after start of PE

    Patient Health Questionnaire (PHQ-9); range 0-27; higher scores indicate worse outcome.

  4. Anxiety

    Time frame: 3 months after start of PE

    Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.

  5. Emotional affect

    Time frame: 3 months after start of PE

    Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome.

  6. Satisfaction with life

    Time frame: 3 months after start of PE

    Satisfaction with Life Scale (SWLS); range 3-35; higher scores indicate better outcome.

  7. Mental health

    Time frame: 3 months after start of PE

    Veterans RAND 12-Item Health Survey Mental Component Score (VR-12 MCS); range 0-100; higher scores indicate better outcome.

Other outcomes

  1. Suicide ideation

    Time frame: 3 months after start of PE

    Beck Scale for Suicide Ideation (BSS) Optimized 6-item Scale; range 0-12; higher score indicates worse outcome.

  2. Suicide cognition

    Time frame: 3 months after start of PE

    Brief Suicide Cognition Scale (B-SCS); range 6-30; higher score indicates worse outcome.

  3. Intrusion (Clinician-assessed)

    Time frame: 3 months after start of PE

    Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5) Criterion B Subscale; range 0-50; higher score indicates worse outcome.

  4. Avoidance (Clinician-assessed)

    Time frame: 3 months after start of PE

    Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion C Subscale; range 0-20; higher score indicates worse outcome.

  5. Cognition and mood (Clinician-assessed)

    Time frame: 3 months after start of PE

    Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R) Criterion D Subscale; range 0-70; higher score indicates worse outcome.

  6. Arousal and reactivity (Clinician-assessed)

    Time frame: 3 months after start of PE

    Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E Subscale; range 0-60; higher score indicates worse outcome.

  7. Intrusion (Self-report)

    Time frame: 3 months after start of PE

    PTSD Checklist for DSM-5 (PCL-5) Criterion B Subscale; range 0-20; higher score indicates worse outcome.

  8. Avoidance (Self-report)

    Time frame: 3 months after start of PE

    PTSD Checklist for DSM-5 (PCL-5) Criterion C Subscale; range 0-8; higher score indicates worse outcome.

  9. Cognition and mood (Self-report)

    Time frame: 3 months after start of PE

    PTSD Checklist for DSM-5 (PCL-5) Criterion D Subscale; range 0-28; higher score indicates worse outcome.

  10. Arousal and reactivity (Self-report)

    Time frame: 3 months after start of PE

    PTSD Checklist for DSM-5 (PCL-5) Criterion E Subscale; range 0-24; higher score indicates worse outcome.

  11. PE Initiation

    Time frame: 3 months after start of PE

    Binary; whether or not the participant initiated prolonged exposure therapy

  12. PE Session Completion

    Time frame: 3 months after start of PE

    # of prolonged exposure therapy sessions completed (out of 12)

  13. PE Treatment Completion

    Time frame: 3 months after start of PE

    Binary; whether or not the participant completed prolonged exposure therapy

  14. PE Compliance

    Time frame: 3 months after start of PE

    # of inter-session homework assignments completed as part of prolonged exposure therapy

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: SERVES+

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 9, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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