Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Co-regulation of norepinephrine between horse and human during EAA sessions.
研究概览
简要总结
The study will examine the effects of eight weeks of equine assisted activities (EAA) on co-regulation, basal physiological values, and symptom severity in veterans with post-traumatic stress disorder (PTSD). Heart rate, respiration rate, surface electromyography (EMG) and plasma concentrations of cortisol, epinephrine, norepinephrine, and oxytocin will be measured at rest and during dyadic interaction tasks (human to human or human to horse) to assess effects of EAA on these measures. Additionally, standard and regularly used questionnaires will be used to monitor PTSD symptom severity during the study and 6-month follow-up period. EAA is expected to lower PTSD symptom severity, and mitigate other physiological changes associated with PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •was deployed and experienced combat in Iraq or Afghanistan
- •between 18 and 65 years of age
排除标准
- •amputation
- •severe traumatic brain injury
- •schizophrenia, bi-polar disorder, or substance dependence in the last 3 months
- •pacemaker
- •allergies to horses
- •previous enrollment in equine assisted activities or psychotherapy in an equine environment
结局指标
主要结局
Co-regulation of norepinephrine between horse and human during EAA sessions.
时间窗: Co-regulation of norepinephrine between horse and human will be assessed once a week during a 30 min session in weeks 1,4, and 8 of an 8 week period.
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma norepinephrine.
Changes in basal plasma cortisol concentration following 8 weeks of EAA
时间窗: Cortisol concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Plasma concentrations of cortisol will be measured via immunoassay following blood draws during rest.
Change from Baseline to the Conclusion of 8 weeks of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
时间窗: Symptoms will be assessed prior to the intervention and immediately following the eight week intervention.
The Brief Symptom Inventory and PTSD Checklist for DSM-5 are questionnaires used to assess the presence and severity of post-traumatic stress disorder symptoms.
Change from Baseline to 6-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
时间窗: Symptoms will be assessed prior to the intervention and 6-months after the end of the EAA sessions.
The Brief Symptom Inventory and PTSD Checklist for DSM-5 are questionnaires used to assess the presence and severity of post-traumatic stress disorder symptoms.
Co-regulation of heart rate between horse and human during EAA sessions.
时间窗: Co-regulation of heart rate between horse and human will be assessed once a week during a 30 min session for 8 weeks..
Co-regulation will be assessed through the telemetric measurement and modeling of heart rate.
Change from Baseline to 2-months After the Conclusion of EAA in PTSD Symptoms as Assessed by PCL-5 & Brief Symptom Inventory
时间窗: Symptoms will be assessed prior to the intervention and 2-months after the end of the EAA sessions.
The Brief Symptom Inventory and PTSD Checklist for DSM-5 are questionnaires used to assess the presence and severity of post-traumatic stress disorder symptoms.
Co-regulation of muscle activity between horse and human during EAA sessions.
时间窗: Co-regulation of muscle activity between horse and human will be assessed once a week during a 30 min session over an 8 week period.
Co-regulation will be assessed through collection of surface electromyography (sEMG) from the masseter, brachiocephalas, and cervical trapezius muscles and subsequent modeling.
Changes in co-regulation of heart rate during dyadic (human-human) interactions following 8 weeks of EAA
时间窗: Co-regulation will be assessed prior to the intervention and immediately following the eight week intervention.
Co-regulation will be assessed through the measurement and modeling of heart rate during gazing, not looking, resting, and mimicking tasks.
Changes in resting heart rate following 8 weeks of EAA
时间窗: Resting heart rate will be assessed prior to the intervention and immediately following the eight week intervention.
Telemetric heart rate monitors will be used to collect resting heart rate.
Co-regulation of epinephrine between horse and human during EAA sessions.
时间窗: Co-regulation of epinephrine between horse and human will be assessed once a week during a 30 min session in weeks 1,4, and 8 of an 8 week period.
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma epinephrine.
Changes in plasma basal oxytocin concentration following 8 weeks of EAA
时间窗: Plasma oxytocin concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Plasma concentrations of oxytocin will be measured via immunoassay following blood draws during rest.
Changes in basal plasma epinephrine concentration following 8 weeks of EAA
时间窗: Plasma epinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Plasma concentrations of epinephrine will be measured via immunoassay following blood draws during rest.
Changes in basal plasma norepinephrine concentration following 8 weeks of EAA
时间窗: Plasma norepinephrine concentrations will be assessed prior to the intervention and immediately following the eight week intervention.
Plasma concentrations of norepinephrine will be measured via immunoassay following blood draws during rest.
Co-regulation of cortisol between horse and human during EAA sessions.
时间窗: Co-regulation of cortisol between horse and human will be assessed once a week during a 30 min session in weeks 1,4, and 8 of an 8 week period.
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma cortisol.
Co-regulation of oxytocin between horse and human during EAA sessions.
时间窗: Co-regulation of oxytocin between horse and human will be assessed once a week during a 30 min session in weeks 1,4, and 8 of an 8 week period.
Co-regulation will be assessed through collection of serial blood samples and subsequent measurement and modeling of plasma oxytocin.
Changes in social motor synchrony during dyadic (human-human) interactions following 8 weeks of EAA
时间窗: Social motor synchrony will be assessed prior to the intervention and immediately following the eight week intervention.
Social motor synchrony will be assessed through the measurement and modeling of gross motor movement during a pendulum swinging task.
次要结局
未报告次要终点
研究者
Karyn Malinowski, Ph.D.
Professor and Director, Rutgers Equine Science Center
Rutgers, The State University of New Jersey