An Internet-administered Randomized Control Trial to Examine the Effects of Regular, Brief Meditation Practice on Mental Health and Well Being
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in Stroop Test Score
研究概览
简要总结
The study will examine the effects of online meditation training on stress and anxiety in healthy participants. It will also examine the dose-response relationship between the amount of daily focused attention meditation practice and established mental health outcome measures.
详细描述
This is a 16-week study with an 8-week meditation intervention, with a requirement of a minimum of 10 minutes of meditation practice each day. This study will recruit ~200 healthy subjects (18+ years) with no current or previous diagnosis of psychiatric or neurological disorders who are interested in learning about meditation but don't have long-term experience with meditation. Half of the participant pool will be randomly assigned to the meditation intervention, and the other half will get the wait-list control assignment. The control group will later receive its intervention, likely a few weeks after the completion of the active group's intervention. A focused-attention meditation technique (SOS meditation) will be used to train participants.
Changes in participants' physiological markers (e.g., HRV, physical activity, respiration rate, sleep quality) will be evaluated using passive activity monitoring devices (e.g., Fitbit). Intervention-related changes in mental health will be assessed using web-based mental health and well-being surveys. Improvements in cognitive functioning will be assessed using web-based psychological tasks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Able to follow basic instructions for prescreening and scheduling
- •Compliant with investigator instructions during the consent process and participation in the study
- •Is not already a regular meditation practitioner
排除标准
- •People with a current diagnosis of psychiatric or neurological disorders
- •Be in current psychiatric treatment or medications
- •Hospitalized for psychiatric disorders in the past year or so.
- •Regular and long-term meditation practitioners
- •Non-English speaking
- •Non-USA mailing address to receive the activity tracker device
- •Vision or hearing impairment severe enough to interfere with study participation
结局指标
主要结局
Change in Stroop Test Score
时间窗: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Using the Stroop test, which measures the average reaction time between incongruent and congruent trials
Resting Heart Rate
时间窗: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Daily obtained from Activity Tracker wrist band
Change in Generalize Anxiety Disorder Questionnaire Score
时间窗: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Anxiety as measured using Generalize Anxiety Disorder Questionnaire
Change in Pittsburgh Sleep Quality Index Questionnaire Score
时间窗: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Sleep Quality measured using Pittsburgh sleep quality index (PSQI)
Change in Mind Wandering Questionnaire Score
时间窗: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Mind wandering measured using the Mind Wandering Questionnaire
Change in N-back Test Score
时间窗: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Using the N-back test is a memory task where participants must remember letters from N trials ago.
Heart Rate Variability
时间窗: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Daily obtained from Activity Tracker wrist band
次要结局
- Change in Brief Strengths Scale Questionnaire Score(Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2))
- Change Social Connectedness Scale-Revised Questionnaire Score(Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2))
- Change in Depression Questionnaire Score(Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2))
- Change in Quality of Life Scale Measures Questionnaire Score(Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2))
- Change in Rumination Reflection Questionnaire Score(Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2))
- Change in Stress Scale Measure Questionnaire Score(Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2))
- Change in Sleep Quality Measure(Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2))
研究者
Manish Saggar
Assistant Professor
Stanford University