Effects of "Alliance180 Program" on Psychological and Physical Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers.
The study aims are:
- Aim #1: to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers;
- Aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention.
Participants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the Alliance180 Program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program. Demographic information will be documented during the baseline research session.
详细描述
All data collection will occur remotely using REDCap (via University of North Carolina, Chapel Hill). As this is a single-arm, feasibility/pilot study, all participants will follow the same protocol.
- Baseline Research Session: self-report completion of demographic information, perception of safety (Neuroception of Psychological Safety, NPSS) and trauma experience (Posttraumatic Stress Disorder Checklist DSM-5, PCL-5), autonomic reactivity (Body Perception Questionnaire, BPQ), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), and perception of events and goals related to purpose in life (Purpose in Life Scale).
- Participate in the 3-day Alliance180 Program (intervention), which includes the Transformative Equine Experience.
- Post-intervention Research Sessions: 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program, self-report completion of perception of safety and trauma experience (NPSS, PCL-5), autonomic reactivity (BPQ), anxiety/depression (HADS) and purpose of events and goals related to purpose in life (Purpose in Life Scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Enrollment in an upcoming "Alliance180 Program". (Enrollment is limited to adults who currently or formerly serve as US Veterans, First Responders and/or Front Line Healthcare Workers and are currently experiencing symptoms related to trauma exposure)
排除标准
- •- Individuals who have previously completed the "Alliance180 Program"
研究组 & 干预措施
Alliance180 Program
Participants will attend the 3-day Alliance180 Program.
干预措施: Alliance180 Program (Other)
结局指标
主要结局
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
时间窗: Baseline, 1 month
The Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior week. The anxiety subscale ranges from 0 to 21, with higher scores indicating higher anxiety complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
时间窗: Baseline, 1 month
The Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of depression over the prior week. The depression subscale ranges from 0 to 21, with higher scores indicating higher depression complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
次要结局
- Change in the Posttraumatic Stress Disorder Checklist (DSM-5)(Baseline, 6 months)
- Change in the Purpose in Life Questionnaire(Baseline, 6 months)
- Change in the Neuroception of Psychological Safety Scale(Baseline, 6 months)
- Change in the Depression Subscale of the Hospital Anxiety and Depression Scale(Baseline, 6 months)
- Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale(Baseline, 6 months)
- Change in the Body Perception Questionnaire(Baseline, 6 months)
- Change in the Body Perception Questionnaire(Baseline, 1 month)
- Change in the Neuroception of Psychological Safety Scale(Baseline, 1 month)
- Change in the Posttraumatic Stress Disorder Checklist (DSM-5)(Baseline, 1 month)
- Change in the Purpose in Life Questionnaire(Baseline, 1 month)