“Alliance180计划”对幸福感的影响
“联盟180计划”对身心健康的影响
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.
研究概览
详细说明
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).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Keri J Heilman, PhD
- 电话号码：913-802-2168
- 邮箱：keri_heilman@med.unc.edu
学习地点
-
-
New York
-
Saratoga Springs、New York、美国、12866
- 招聘中
- Alliance180
-
接触：
- Janelle Huggard
- 电话号码：518-225-8353
-
副研究员：
- Bob Nevins
-
副研究员：
- Janelle Huggard
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599-7160
- 招聘中
- University of North Carolina at Chapel Hill
-
接触：
- Keri J Heilman, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Individuals who have previously completed the "Alliance180 Program"
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Alliance180 Program
Participants will attend the 3-day Alliance180 Program. |
The Alliance180 Program promotes feelings of neuropsychological safety and trust in the context of a 3-day program, which includes the transformative equine experience. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
大体时间：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. |
Baseline, 1 month
|
|
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
大体时间：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. |
Baseline, 1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the Body Perception Questionnaire
大体时间：Baseline, 1 month
|
Body Perception Questionnaire (BPQ) is a self-report questionnaire, which includes a 20-item subscale for Autonomic Nervous System Reactivity. Only the Autonomic Nervous System Reactivity subscale will be administered. Raw scores range from 0-100, with higher scores indicating greater level of symptoms associated with autonomic activity (poorer outcome). Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level. |
Baseline, 1 month
|
|
Change in the Neuroception of Psychological Safety Scale
大体时间：Baseline, 1 month
|
Neuroception of Psychological Safety Scale (NPSS) is a self-report questionnaire, which contains 29-items. Raw scores range from 29-145, with higher scores indicating stronger feelings of psychological safety. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level. |
Baseline, 1 month
|
|
Change in the Posttraumatic Stress Disorder Checklist (DSM-5)
大体时间：Baseline, 1 month
|
Posttraumatic Stress Disorder Checklist (DSM-5) (PCL-5) is a self-report questionnaire, which contains 20-items. Raw scores range from 0-80, with higher scores indicating more symptoms of PTSD. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level. |
Baseline, 1 month
|
|
Change in the Purpose in Life Questionnaire
大体时间：Baseline, 1 month
|
Purpose in Life Questionnaire is a self-report questionnaire, which contains 12-items. Raw scores range from 0-60, with higher scores indicating a greater sense of purpose in life. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level. |
Baseline, 1 month
|
|
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
大体时间：Baseline, 6 months
|
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. |
Baseline, 6 months
|
|
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
大体时间：Baseline, 6 months
|
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. |
Baseline, 6 months
|
|
Change in the Body Perception Questionnaire
大体时间：Baseline, 6 months
|
Body Perception Questionnaire (BPQ) is a self-report questionnaire, which includes a 20-item subscale for Autonomic Nervous System Reactivity. Only the Autonomic Nervous System Reactivity subscale will be administered. Raw scores range from 0-100, with higher scores indicating greater level of symptoms associated with autonomic activity (poorer outcome). Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level. |
Baseline, 6 months
|
|
Change in the Neuroception of Psychological Safety Scale
大体时间：Baseline, 6 months
|
Neuroception of Psychological Safety Scale (NPSS) is a self-report questionnaire, which contains 29-items. Raw scores range from 29-145, with higher scores indicating stronger feelings of psychological safety. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level. |
Baseline, 6 months
|
|
Change in the Posttraumatic Stress Disorder Checklist (DSM-5)
大体时间：Baseline, 6 months
|
Posttraumatic Stress Disorder Checklist (DSM-5) (PCL-5) is a self-report questionnaire, which contains 20-items. Raw scores range from 0-80, with higher scores indicating more symptoms of PTSD. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level. |
Baseline, 6 months
|
|
Change in the Purpose in Life Questionnaire
大体时间：Baseline, 6 months
|
Purpose in Life Questionnaire is a self-report questionnaire, which contains 12-items. Raw scores range from 0-60, with higher scores indicating a greater sense of purpose in life. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level. |
Baseline, 6 months
|
合作者和调查者
调查人员
- 首席研究员：Keri J Heilman, PhD、University of North Carolina, Chapel Hill
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina, Chapel Hill (UNC).
IPD 共享时间框架
Beginning 9 and continuing for 36 months after publication
IPD 共享访问标准
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina, Chapel Hill (UNC).
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
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研究美国 FDA 监管的设备产品
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