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NCT Number: NCT07542431

Impact of Dog Adoption and Training 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Dog training

Other

Eight, one-hour professional dog training sessions over 8-10 weeks

Primary outcomes

  1. Change in self-reported posttraumatic stress disorder (PTSD) symptoms from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

Secondary outcomes

  1. Change in depression symptom severity from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  2. Change in anxiety symptom severity from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  3. Change in perceived stress severity from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  4. Change in sleep disturbance from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  5. Change in loneliness from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  6. Change in alcohol use from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  7. Change in cannabis use from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  8. Change in salivary oxytocin levels from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  9. Change in Interleukin-1 beta (IL-1β) from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  10. Change in Interleukin-6 (IL-6) from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  11. Change in tumor necrosis factor-alpha (TNF-alpha) from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

Other outcomes

  1. Change in alcohol demand for participants who answer "yes" to alcohol consumption in the AUDIT measure from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  2. Change in cannabis demand for participants who answer "yes" to cannabis use from baseline to 4 weeks post-intervention

    Time frame: From enrollment 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.

  3. Change in Magnetic Resonance Imaging (MRI) biomarkers from baseline to 4 weeks post-intervention

    Time frame: Pre-intervention and 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Beth A Pratt, PhD

CONTACT

[email protected]

561-297-4912

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Registry information

Official study title

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

Acronym: VCRM

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 21, 2026
Registry last updated
Apr 24, 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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