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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida Atlantic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Fear of dogs

Allergies to pet dander

Uncorrected hearing or visual impairment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dog training

    Other intervention

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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Study InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to 4 weeks post-intervention

Secondary outcomes

1

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.

Time frame
From enrollment to 4 weeks post-intervention
2

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.

Time frame
From enrollment to 4 weeks post-intervention
3

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.

Time frame
From enrollment to 4 weeks post-intervention
4

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.

Time frame
From enrollment to 4 weeks post-intervention

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

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.

Time frame
From enrollment to 4 weeks post-intervention
2

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.

Time frame
From enrollment to 4 weeks post-intervention
3

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)

Time frame
Pre-intervention and 4 weeks post-intervention

Sponsors and contacts

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