Impact of Dog Adoption and Training in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions (VCRM)

Assessment of Biopsychosocial Indicators Linked to Canine Intervention Treatment Response in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions

The goal of this single-arm study is to learn if a dog adoption and training program can treat, prevent in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main questions it aims to answer are:

• Does the dog adoption and training program decrease posttraumatic stress symptoms in veterans with self-reported posttraumatic stress symptoms?
• Does the dog adoption and training program decrease stress and improve psychosocial health in veterans with self-reported posttraumatic stress symptoms?
• Does the dog adoption and training program decrease inflammation, increase oxytocin, and change the structure and resting-state function of specific brain regions in veterans with self-reported posttraumatic stress symptoms?

Participants will:

• Attend eight one-hour professional dog training sessions within a 10-week period.
• Visit the clinical research unit four times during the study for data collection.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Symptoms; Mental Health Conditions
• Intervention / Treatment: Other: Dog training

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth A Pratt, PhD; Phone Number: 561-297-4912; Email: bpratt4@health.fau.edu

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Recruiting
      • Florida Atlantic University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Military veteran with self-reported posttraumatic stress symptoms and/or other mental health conditions
• Over 18 years of age
• Applied and approved to adopt a shelter dog for training through the Humane Society of Broward County in Fort Lauderdale, Florida
• English speaker (written and spoken)
• Home internet access via tablet, computer or smartphone.

Exclusion Criteria:

• Fear of dogs
• Allergies to pet dander
• Uncorrected hearing or visual impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Intervention; Within-subjects design	Other: Dog training; Eight, one-hour professional dog training sessions over 8-10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported posttraumatic stress disorder (PTSD) symptoms from baseline to 4 weeks post-intervention	Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of PTSD symptoms with scores ranging from 0 to 80.	From enrollment to 4 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression symptom severity from baseline to 4 weeks post-intervention	Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptoms with scores ranging from 0 to 27.	From enrollment to 4 weeks post-intervention
Change in anxiety symptom severity from baseline to 4 weeks post-intervention	Generalized Anxiety Disorder-7 (GAD-7) is a is a 7-item self-report measure of anxiety symptoms with scores ranging from 0 to 21.	From enrollment to 4 weeks post-intervention
Change in perceived stress severity from baseline to 4 weeks post-intervention	Perceived Stress Scale-10 (PSS-10) is a 10-item self-report measure of perceived stress symptoms with scores ranging from 0 to 40.	From enrollment to 4 weeks post-intervention
Change in sleep disturbance from baseline to 4 weeks post-intervention	Patient-Reported Outcomes Measurement Information System Sleep 8b (PROMIS Sleep 8b) is an 8-item self-report measure of sleep quality over the past 7 days with raw scores ranging from 8 to 40 and standardized T scores ranging from 28.9 to 76.5.	From enrollment to 4 weeks post-intervention
Change in loneliness from baseline to 4 weeks post-intervention	Revised UCLA Loneliness Scale is a 20-item self-report measure of loneliness with scores ranging from 20 to 80.	From enrollment to 4 weeks post-intervention
Change in alcohol use from baseline to 4 weeks post-intervention	Alcohol Use Disorder Identification Test (AUDIT) is a 10-item self-report measure of alcohol use with scores ranging from 0 to 40.	From enrollment to 4 weeks post-intervention
Change in cannabis use from baseline to 4 weeks post-intervention	Cannabis Use Disorder Identification Test (CUDIT) is an 8-item self-report measure of cannabis use with scores ranging from 0 to 32.	From enrollment to 4 weeks post-intervention
Change in salivary oxytocin levels from baseline to 4 weeks post-intervention	Oxytocin is a neurotransmitter that plays a role in determining social behavior. Salivary oxytocin levels range from 6.4-1000 pg/mL.	From enrollment to 4 weeks post-intervention
Change in Interleukin-1 beta (IL-1β) from baseline to 4 weeks post-intervention	IL-1β is a pro-inflammatory cytokine found to be higher in individuals with PTSD compared to healthy controls. IL-1β is measured via capillary blood obtained via fingerstick.	From enrollment to 4 weeks post-intervention
Change in Interleukin-6 (IL-6) from baseline to 4 weeks post-intervention	IL-6 is a pro-inflammatory cytokine found to be higher in individuals with PTSD compared to healthy controls. IL-6 is measured via capillary blood obtained via fingerstick.	From enrollment to 4 weeks post-intervention
Change in tumor necrosis factor-alpha (TNF-alpha) from baseline to 4 weeks post-intervention	TNF-alpha is a pro-inflammatory cytokine found to be higher in individuals with PTSD compared to healthy controls. TNF-alpha is measured via capillary blood obtained via fingerstick.	From enrollment to 4 weeks post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in alcohol demand for participants who answer "yes" to alcohol consumption in the AUDIT measure from baseline to 4 weeks post-intervention	Alcohol Purchase Task is a tool to measure alcohol demand by asking individuals how many drinks they would consume at prices ranging from free to high, using behavioral economic indices for scoring.	From enrollment to 4 weeks post-intervention
Change in cannabis demand for participants who answer "yes" to cannabis use from baseline to 4 weeks post-intervention	Cannabis Purchase Task is a tool to measure cannabis demand by assessing how much an individual purchases at increasing prices.	From enrollment to 4 weeks post-intervention
Change in Magnetic Resonance Imaging (MRI) biomarkers from baseline to 4 weeks post-intervention	Optional participation in an MRI to detect changes in the structure and resting-state function of specific brain regions (anterior cingulate, amygdala, hippocampus, and insula)	Pre-intervention and 4 weeks post-intervention

Collaborators and Investigators

• Sponsor: Florida Atlantic University
• Investigators: Principal Investigator: Beth A Pratt, PhD, Florida Atlantic University; Principal Investigator: Cheryl A Krause-Parello, PhD, Florida Atlantic University

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB2310227

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No