The Dynamic Mechanism of Mindfulness Intervention for Emotional Distress (MIED) Based on Ecological Moment Measurement
2026年9月2日 更新者：Xinghua Liu、Peking University
The goal of this clinical trial is to examine how a mindfulness-based intervention (MIED) affects the moment-to-moment, lagged relationships between mechanism variables at the levels of feelings, thoughts, and behaviors and outcomes (anxiety and depression) in individuals experiencing anxiety and depressive distress, using high-frequency ecological momentary assessment. The main questions it aims to answer are:
At the within-person level, do these mechanism variables significantly predict next-moment anxiety and depressive symptoms at the within-day micro-scale?
How does the temporal dynamic between mechanism and outcomes over the course of MIED?
研究概览
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：MO CHEN
- 电话号码：86 +18950308693
- 邮箱：amor_chen@foxmail.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
Exclusion Criteria:
- Subjects who could not access the Internet.
- Subjects with insufficient Chinese ability.
- Subjects who have participated in mindfulness-based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week.
- Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder.
- Subjects at risk of suicide.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 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 |
|---|---|
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实验性的：MIED Self-help Intervention Group
Participants receive a 49-day self-help intervention delivered via a Mini Program.
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A 49-day digital self-help program delivered via a WeChat Mini Program (or mobile app).
Each day, participants receive a new set of materials: (a) a guided mindfulness meditation audio (10-30 minutes), (b) psychoeducational content in text or audio format covering mindfulness principles, emotion, and emotional distress, and (c) daily assignments (such as informal mindfulness practices, emotion journaling, and graded challenging tasks).
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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 |
|---|---|---|
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changes of depression
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of anxiety
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of mindfulness
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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The Daily Mindfulness Response Scale measures the frequency with which one returns to a nonjudgmental and unconditionally receptive present moment awareness during the day.
Each item is rated on a scale ranging from 1 (rarely) to 10 (often).
scores range from 4 to 40, with higher scores indicating higher levels of mindful responding
|
At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
|
changes of distress tolerance
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
3 items were chosen to form the Daily Distress Tolerance Scale (DDTS).
The DDTS consists of four items.
Each item is rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree).
Scores range from 3 to 15, with higher scores indicating greater distress tolerance.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of engaging in life
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
4 items were chosen from Enaging in Life Scale which assesses the extent to which individuals' daily engagement in life domains (such as work, social interactions, and leisure activities) is affected by physical and psychological discomfort, scores range from 0 to 16, with higher scores indicating higher levels of engaging in everyday life (Chen et al.,2026).
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of physical distress intolerance
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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Momentary bodily discomfort tolerance will be assessed using a single self-developed item: "Right now, I am able to allow unpleasant bodily sensations to be present without trying to get rid of them immediately."
Participants will respond on a 7-point scale ranging from 0 ("not at all able") to 6 ("completely able").
Higher scores indicate greater momentary ability to tolerate and allow unpleasant bodily sensations without immediately attempting to avoid or eliminate them.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of experiential avoidance
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
Based on a preliminary study, the items with the high factor loading （at least higher than 0.6） from each subscale of the Brief Experiential Avoidance Questionnaire ( Gámez et al, 2013) were chosen to form the Daily Experiential Avoidance Scale (DEAS).
The DEAS consists of four items.
Each item is rated on a scale ranging from 1 (strongly agree) to 6 (strongly disagree).
Scores range from 5 to 30, with higher scores indicating less experiential avoidance.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of rumination
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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State rumination will be assessed using a single-item visual analogue scale adapted from prior research.
Participants will rate the extent to which they are currently caught up in their emotions and problems and find it difficult to step back from them ("Right now, I am caught up in my emotions and problems and find it difficult to distance myself from them") on a slider ranging from 0 ("not at all") to 100 ("extremely").
Higher scores indicate greater momentary rumination.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
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changes of negative emotion
大体时间：At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
|
Negative affect will be assessed using four items adapted from the Positive and Negative Affect Schedule (PANAS).
Participants will rate the intensity of their current feelings of anxiety, sadness, irritability, and tension ("Right now, I feel anxious/sad/irritable/tense") using a visual analogue slider ranging from 0 ("not at all") to 100 ("extremely").
Higher scores indicate greater momentary negative affect.
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At baseline (within 1 week pre-intervention), at Week 1, Week 4, Week 7 of intervention, within 1 week post-intervention, and at 1-month follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月5日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月22日
研究注册日期
首次提交
2026年8月27日
首先提交符合 QC 标准的
2026年9月2日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.