Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress Scale (PSS) Score
研究概览
简要总结
This study is a randomized controlled trial to test the impact of an app-based meditation program on perceived stress and behavioral correlates of stress with known neurobiological correlates. Healthy adult participants between the ages of 25-65 will be enrolled in the study for about 4-5 months.
详细描述
Participants will be randomized into one of two groups: the intervention group or the waitlist control group. The intervention group will use a mobile health app for four weeks. Participants will complete pre-intervention, weekly, post-intervention, and 3-month follow-up surveys and tasks.
Primary Objective: Test for hypothesized group differences in perceived stress during participation in a 4-week meditation program and at 3-month follow-up.
Secondary Objective: Within the meditation group, determine whether reductions in perceived stress are associated with changes in hippocampal-dependent behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individual can read, write, speak, and understand English
- •Able to provide informed consent
- •Willing and able to complete all study procedures, including the Healthy Minds Program
- •Has access to a smartphone that can download apps from Google Play or the Apple App Store
- •US citizen or a permanent US resident (green card holder)
排除标准
- •Extensive experience in meditation practice (e.g., regular daily meditation practice for the past 6 months or regular weekly meditation practice for the past 12 months), experience in substantively similar meditation training programs (e.g., attended a meditation retreat or a yoga/body practice retreat with a significant mediation component), or substantial previous use of the Healthy Minds Program app
- •Individuals will be excluded if they previously participated in substantively similar research at our Center at the discretion of the investigator due to similar tasks being used in certain studies
- •History of psychosis
- •History of mania
- •Current psychopathology that interferes with study participation
研究组 & 干预措施
Waitlist Control
Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Healthy Minds Program (HMP)
Fully remote, 4-week meditation intervention
干预措施: mHealth Meditation (Behavioral)
结局指标
主要结局
Change in Perceived Stress Scale (PSS) Score
时间窗: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
PSS is a 10-item survey scored on a 5 point likert scale from 0 = never to 4 = very often, for a total possible range of scores from 0-40 where higher scores indicate higher perceived stress.
次要结局
- Change in Behavioral Pattern Separation Task(Baseline, following week 4 of intervention period, and 3 month follow-up)
- Change in PROMIS Depression Score(Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up)
- Change in PROMIS Anxiety Score(Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up)