An interventional study of Psychiatric Service Dog and Prolonged Exposure Therapy in Stress Disorders, Post-Traumatic, PTSD and Animal-Human Bonding, sponsored by University of Arizona. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by University of Arizona · Not applicable, Interventional, and Treatment
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.
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 216 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
Participants will receive 12 weeks of Prolonged Exposure once per week with the addition of a service dog
Other: Psychiatric Service Dog · Behavioral: Prolonged Exposure Therapy
Participants will receive 12 weeks of Prolonged Exposure once per week
Behavioral: Prolonged Exposure Therapy
Partnership with a trained service dog for PTSD.
12 weeks of Prolonged Exposure once per week.
PTSD Symptom Severity (Self-report)
PTSD Checklist for DSM-5 (PCL-5) Total Score; range 0-80; higher scores indicate worse outcome.
Time frame: 3 months after start of PE
PTSD Symptom Severity (Clinician-assessed)
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Total Score; range 0-200; higher scores indicate worse outcome.
Time frame: 3 months after start of PE
PTSD Diagnosis
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Diagnosis; binary
Time frame: 3 months after start of PE
Depression
Patient Health Questionnaire (PHQ-9); range 0-27; higher scores indicate worse outcome.
Time frame: 3 months after start of PE
Anxiety
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.
Time frame: 3 months after start of PE
Emotional affect
Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome.
Time frame: 3 months after start of PE
Satisfaction with life
Satisfaction with Life Scale (SWLS); range 3-35; higher scores indicate better outcome.
Time frame: 3 months after start of PE
Mental health
Veterans RAND 12-Item Health Survey Mental Component Score (VR-12 MCS); range 0-100; higher scores indicate better outcome.
Time frame: 3 months after start of PE
Suicide ideation
Beck Scale for Suicide Ideation (BSS) Optimized 6-item Scale; range 0-12; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Suicide cognition
Brief Suicide Cognition Scale (B-SCS); range 6-30; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Intrusion (Clinician-assessed)
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5) Criterion B Subscale; range 0-50; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Avoidance (Clinician-assessed)
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion C Subscale; range 0-20; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Cognition and mood (Clinician-assessed)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R) Criterion D Subscale; range 0-70; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Arousal and reactivity (Clinician-assessed)
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E Subscale; range 0-60; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Intrusion (Self-report)
PTSD Checklist for DSM-5 (PCL-5) Criterion B Subscale; range 0-20; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Avoidance (Self-report)
PTSD Checklist for DSM-5 (PCL-5) Criterion C Subscale; range 0-8; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Cognition and mood (Self-report)
PTSD Checklist for DSM-5 (PCL-5) Criterion D Subscale; range 0-28; higher score indicates worse outcome.
Time frame: 3 months after start of PE
Arousal and reactivity (Self-report)
PTSD Checklist for DSM-5 (PCL-5) Criterion E Subscale; range 0-24; higher score indicates worse outcome.
Time frame: 3 months after start of PE
PE Initiation
Binary; whether or not the participant initiated prolonged exposure therapy
Time frame: 3 months after start of PE
PE Session Completion
\# of prolonged exposure therapy sessions completed (out of 12)
Time frame: 3 months after start of PE
PE Treatment Completion
Binary; whether or not the participant completed prolonged exposure therapy
Time frame: 3 months after start of PE
PE Compliance
\# of inter-session homework assignments completed as part of prolonged exposure therapy
Time frame: 3 months after start of PE
Plan to share: No
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