Florida Atlantic University
Boca Raton, Florida, 33431, United States
Location status: Recruiting
NCT Number: NCT07542431
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boca Raton, Florida, 33431, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eight, one-hour professional dog training sessions over 8-10 weeks
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
Contact information is provided by the study sponsor or research team.
Florida Atlantic University
Other
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
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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