NCT06723834

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
53mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Sep 2025Sep 2030

First Submitted

Initial submission to the registry

December 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

September 23, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

February 20, 2026

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

December 4, 2024

Last Update Submit

February 17, 2026

Conditions

Stress Disorders, Post-TraumaticPTSDAnimal-Human BondingCombat Stress Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • PTSD Symptom Severity (Clinician-assessed)

    3 months after start of PE

  • PTSD Diagnosis

    3 months after start of PE

  • Depression

    3 months after start of PE

  • Anxiety

    3 months after start of PE

  • Emotional affect

    3 months after start of PE

  • +2 more secondary outcomes

Other Outcomes (14)

  • Suicide ideation

    3 months after start of PE

  • Suicide cognition

    3 months after start of PE

  • Intrusion (Clinician-assessed)

    3 months after start of PE

  • +11 more other outcomes

Study Arms (2)

PTSD Service Dog + Prolonged Exposure Therapy

EXPERIMENTAL

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

Other: Psychiatric Service DogBehavioral: Prolonged Exposure Therapy

Prolonged Exposure Therapy Alone

ACTIVE COMPARATOR

Participants will receive 12 weeks of Prolonged Exposure once per week

Behavioral: Prolonged Exposure Therapy

Interventions

Psychiatric Service DogOTHER

Partnership with a trained service dog for PTSD.

PTSD Service Dog + Prolonged Exposure Therapy
Prolonged Exposure TherapyBEHAVIORAL

12 weeks of Prolonged Exposure once per week.

PTSD Service Dog + Prolonged Exposure TherapyProlonged Exposure Therapy Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current service dog
  • Current participation in Prolonged Exposure Therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticHuman-Animal BondCombat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersHuman-Animal InteractionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
(Secondary outcome) PTSD Severity and symptoms via blinded clinician rating, employing the Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5-R, Range 0-80, Lower scores indicate a better outcome)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 9, 2024

Study Start

September 23, 2025

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Last Updated

February 20, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)