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
- 2
- 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
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)