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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: PTSD; Stress Disorders, Post-Traumatic; Combat Stress Disorders; Animal-Human Bonding
• Intervention / Treatment: Other: Psychiatric Service Dog; Behavioral: Prolonged Exposure Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTSD Service Dog + Prolonged Exposure Therapy; Participants will receive 12 weeks of Prolonged Exposure once per week with the addition of a service dog	Other: Psychiatric Service Dog; Partnership with a trained service dog for PTSD.; Behavioral: Prolonged Exposure Therapy; 12 weeks of Prolonged Exposure once per week.
Active Comparator: Prolonged Exposure Therapy Alone; Participants will receive 12 weeks of Prolonged Exposure once per week	Behavioral: Prolonged Exposure Therapy; 12 weeks of Prolonged Exposure once per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Symptom Severity (Self-report)	PTSD Checklist for DSM-5 (PCL-5) Total Score; range 0-80; higher scores indicate worse outcome.	3 months after start of PE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Patient Health Questionnaire (PHQ-9); range 0-27; higher scores indicate worse outcome.	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.	3 months after start of PE
Emotional affect	Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome.	3 months after start of PE
Satisfaction with life	Satisfaction with Life Scale (SWLS); range 3-35; higher scores indicate better outcome.	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.	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.	3 months after start of PE
PTSD Diagnosis	Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Diagnosis; binary	3 months after start of PE

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PE Initiation	Binary; whether or not the participant initiated prolonged exposure therapy	3 months after start of PE
PE Session Completion	# of prolonged exposure therapy sessions completed (out of 12)	3 months after start of PE
PE Treatment Completion	Binary; whether or not the participant completed prolonged exposure therapy	3 months after start of PE
PE Compliance	# of inter-session homework assignments completed as part of prolonged exposure therapy	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.	3 months after start of PE
Suicide cognition	Brief Suicide Cognition Scale (B-SCS); range 6-30; higher score indicates worse outcome.	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.	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.	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.	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.	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.	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.	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.	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.	3 months after start of PE

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2025
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Behavior; Human-Animal Interaction; Stress Disorders, Post-Traumatic; Combat Disorders; Human-Animal Bond
• Other Study ID Numbers: HT9425-24-1-0178; CDMRP-PR230987 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No