Posttraumatic Stress SymptomsVCRMNCT07542431
Impact of Dog Adoption and Training in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions
A study testing Dog training in people with Posttraumatic Stress Symptoms and Mental Health Conditions, run by Florida Atlantic University at 1 site in United States.
Trial summary
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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Symptoms, Mental Health Conditions
- What is being tested?
- Dog training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Fear of dogs
- Allergies to pet dander
- Uncorrected hearing or visual impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida Atlantic University
Boca Raton, Florida, 33431
About this study
Official title: 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?
Read more
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.
- Being tested
- Dog training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog trainingOther
Eight, one-hour professional dog training sessions over 8-10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention | Experimental | Within-subjects design Receives: Other: Dog training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 4 weeks post-intervention
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start9 Feb 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Pratt, Florida Atlantic University
- Investigators
- Beth A Pratt, PhD, Principal investigator, Florida Atlantic UniversityCheryl A Krause-Parello, PhD, Principal investigator, Florida Atlantic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542431
- Sponsor's protocol ID
- IRB2310227
- Acronym
- VCRM
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Biopsychosocial Indicators Linked to Canine Intervention Treatment Response in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions
- ClinicalTrials.gov ID
- NCT07542431
- Acronym / sponsor ID
- VCRM / IRB2310227
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Intervention | Experimental | Other: Dog trainingWithin-subjects design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Fear of dogs
- Allergies to pet dander
- Uncorrected hearing or visual impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dog trainingEight, one-hour professional dog training sessions over 8-10 weeks | Other | Study Intervention |
Primary outcome
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.
11 secondary outcomes
Change in depression symptom severity from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in anxiety symptom severity from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in perceived stress severity from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in sleep disturbance from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in loneliness from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in alcohol use from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in cannabis use from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in salivary oxytocin levels from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in Interleukin-1 beta (IL-1β) from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in Interleukin-6 (IL-6) from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Change in tumor necrosis factor-alpha (TNF-alpha) from baseline to 4 weeks post-intervention
Time frame: From enrollment to 4 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beth A Pratt, PhD principal investigator
Florida Atlantic University
Cheryl A Krause-Parello, PhD principal investigator
Florida Atlantic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog training in people with Posttraumatic Stress Symptoms and Mental Health Conditions, run by Florida Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth A Pratt, PhD (561-297-4912, bpratt4@health.fau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.