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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Dog training
Other interventionEight, one-hour professional dog training sessions over 8-10 weeks
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
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.
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)
Sponsors and contacts
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