NCT07542431招募中不适用
Assessment of Biopsychosocial Indicators Linked to Canine Intervention Treatment Response in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Posttraumatic stress symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Fear of dogs
- •Allergies to pet dander
- •Uncorrected hearing or visual impairment.
研究组 & 干预措施
Study Intervention
Experimental
Within-subjects design
干预措施: Dog training (Other)
结局指标
主要结局
Posttraumatic stress symptoms
时间窗: From enrollment to 4 weeks post-intervention
PTSD Checklist for DSM-5 (PCL-5)
Change in self-reported posttraumatic stress disorder (PTSD) symptoms from baseline to 4 weeks post-intervention
时间窗: 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.
次要结局
- Depression severity(From enrollment to 4 weeks post-intervention)
- Anxiety severity(From enrollment to 4 weeks post-intervention)
- Perceived stress severity(From enrollment to 4 weeks post-intervention)
- Sleep disturbance(From enrollment to 4 weeks post-intervention)
- Loneliness(From enrollment to 4 weeks post-intervention)
- Alcohol use(From enrollment to 4 weeks post-intervention)
- Cannabis use(From enrollment to 4 weeks post-intervention)
- Change in depression symptom severity from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in anxiety symptom severity from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in perceived stress severity from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in sleep disturbance from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in loneliness from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in alcohol use from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in cannabis use from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in salivary oxytocin levels from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in Interleukin-1 beta (IL-1β) from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in Interleukin-6 (IL-6) from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
- Change in tumor necrosis factor-alpha (TNF-alpha) from baseline to 4 weeks post-intervention(From enrollment to 4 weeks post-intervention)
研究者
Beth Pratt
Assistant Professor
Florida Atlantic University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Between Paws and Affections - Impact of Dog-Assisted Therapy in Fibromyalgia PatientsFibromyalgia (FM)NCT07356206University of Minho60
已完成
不适用
Biopsychosocial vs Multimodal Chronic Pain ManagementNCT07406711Osijek University Hospital128
尚未招募
不适用
Preliminary Efficacy of the AdoptMindful2Care@Web: A Web-Based Mindful Parenting Post-Adoption Intervention for Adoptive ParentsParenting StressPositive Mental HealthNCT07534111University of Coimbra90
已完成
不适用
Benefits of Animal-Assisted Therapy for people with Autism Spectrum DisordersCTRI/2022/12/048569Hemangi Narayan Narvekar4
尚未招募
不适用
Stress Management Intervention for Young Turkish WomenNCT07357129Bogazici University60