Mental Health Conditions, Posttraumatic Stress Symptoms
Conditions
Brief summary
The goal of this single-arm study is to learn if a dog adoption and training program can treat, prevent in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. 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.
Interventions
OTHERDog training
Eight, one-hour professional dog training sessions over 8-10 weeks
Sponsors
Florida Atlantic University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported posttraumatic stress disorder (PTSD) symptoms from baseline to 4 weeks post-intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in depression symptom severity from baseline to 4 weeks post-intervention | 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. |
| Change in anxiety symptom severity from baseline to 4 weeks post-intervention | 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. |
| Change in perceived stress severity from baseline to 4 weeks post-intervention | 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. |
| Change in sleep disturbance from baseline to 4 weeks post-intervention | 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. |
| Change in loneliness from baseline to 4 weeks post-intervention | 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. |
| Change in alcohol use from baseline to 4 weeks post-intervention | 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. |
| Change in cannabis use from baseline to 4 weeks post-intervention | 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. |
| Change in salivary oxytocin levels from baseline to 4 weeks post-intervention | 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. |
| Change in Interleukin-1 beta (IL-1β) from baseline to 4 weeks post-intervention | 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. |
| Change in Interleukin-6 (IL-6) from baseline to 4 weeks post-intervention | 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. |
| Change in tumor necrosis factor-alpha (TNF-alpha) from baseline to 4 weeks post-intervention | 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. |
Countries
United States
Contacts
CONTACTBeth A Pratt, PhD
PRINCIPAL_INVESTIGATORBeth A Pratt, PhD
Florida Atlantic University
PRINCIPAL_INVESTIGATORCheryl A Krause-Parello, PhD
Florida Atlantic University
Outcome results
None listed