跳至主要内容
临床试验/NCT07280481
NCT07280481招募中不适用

Weekly Dynamics of Psychopathological and Symptom Networks During Mindfulness-Based Interventions for Emotional Distress

Peking University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年11月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
2
主要终点
Weekly changes of Overall Depression Severity and Impairment

研究概览

简要总结

The goal of this clinical study is to learn how Mindfulness Intervention for Emotional Distress (MIED) helps people with emotional distress and how their symptoms and psychological patterns change over time.

The main questions it aims to answer are:

  • How do the relationships between emotions, thoughts, and behaviors change week by week during mindfulness training?
  • Which psychological skills, such as distress tolerance or cognitive flexibility, improve first and lead to later emotional relief? Two groups will be compared - one that takes part in an online mindfulness intervention and one that waits to join - to see how the intervention changes emotional and psychological networks over time.

Participants will:

  • Complete a 7-week online self-guided Mindfulness Intervention for Emotional Distress(iMIED) designed for people experiencing high emotional distress.
  • Fill out short weekly questionnaires about their emotions, thoughts, and behaviors before, during, and after the course (9 times in total).
  • Receive access to the mindfulness program after the study if they are in the wait-list group.

This study includes about 500 adults aged 18 and older who feel anxious, depressed, or emotionally distressed but have no major psychiatric disorders. By tracking weekly changes, the research aims to identify how mindfulness intervention leads to emotional improvement and which skills play the most important roles in that process.

详细描述

Research Background Traditional psychotherapy research tends to emphasize description rather than explanation, relying excessively on data accumulation while neglecting theoretical construction and development (Gelo & Salvatore, 2016). Complex network theory and its related methods can overcome the limitations of traditional empiricism, providing a deeper theoretical framework and analytical tools for psychotherapy research. By applying complex network methods, it becomes possible to comprehensively analyze the multidimensional and multicausal dynamic relationships between symptoms or psychological variables during psychotherapy, thus gaining a clearer understanding of the processes underlying the development and recovery of mental health problems.

Network analysis can reveal the direct connections between different variables (Borsboom, 2017), rather than relying solely on changes in overall mean levels. Combined with multi-time-point measurement designs, researchers can track gradual changes in relationships between variables during the intervention, thereby identifying which associations change first in the therapeutic process and which variables may play key roles throughout the intervention (Blanken et al., 2019; Cervin et al., 2020). This contributes to an in-depth exploration of the mechanisms underlying psychological interventions and a more comprehensive understanding of change patterns in the therapeutic process.

Mindfulness-Based Interventions (MBIs) are a form of psychotherapy whose effectiveness has been widely validated (Wielgosz et al., 2019). Through regular mindfulness practice, individuals tend to develop healthier behavioral patterns, such as reduction of substance abuse, self-harm, suicidal behaviors, and eating disorder symptoms (Schuman-Olivier et al., 2020). Mindfulness-centered interventions are applicable to both clinical and non-clinical populations: not only to patients with physical or mental disorders (Carlson, 2012; Turgon et al., 2019), but also to individuals experiencing behavioral or emotional distress (Ju, 2022; Ma et al., 2018), all of whom can benefit from short-term or long-term mindfulness practice. Both traditional face-to-face formats and online mindfulness programs have been shown to improve emotional well-being and enhance quality of life (Li et al., 2025; Taylor et al., 2021). The convenience and accessibility of online interventions, in particular, enable more people experiencing emotional distress to receive continuous psychological support.

In addition to studying the efficacy of interventions, understanding the mechanisms of mindfulness interventions is equally important. Many researchers have begun to explore the mechanisms underlying Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) (Gu et al., 2015; Maloney et al., 2024). Traditional mechanism studies are mostly based on mediation models that conceptualize mechanisms as static variables linking interventions and outcomes (Kazdin, 2007), making it difficult to capture the dynamic interactions among multiple variables (such as distress tolerance, experiential avoidance, and cognitive flexibility) during the intervention process. The cross-diagnostic interactions and longitudinal predictive relationships between these transdiagnostic factors and anxiety or depressive symptoms during intervention remain unclear.

Therefore, to gain a deeper understanding of how mindfulness interventions "take effect" and the "change patterns" that occur during the process, this study is based on Liu's (2024) Rhombus Model of Psychopathology in Emotional Distress. Using a randomized controlled trial design, weekly measurements will be conducted on individuals participating in an online mindfulness intervention. By applying network analysis methods, this study will focus on the weekly dynamics of psychopathological and symptom networks formed by key mechanism variables-distress tolerance, experiential avoidance, life engagement, and cognitive flexibility-as well as anxiety and depression symptoms during the intervention. The aim is to systematically reveal the dynamic processes and core pathways through which mindfulness interventions drive psychological change.

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

入选标准

  • experiencing emotional distress such as depression or anxiety (Kessler-10 score > 21)

排除标准

  • prior experience with mindfulness meditation
  • current self-harm or suicidal risk
  • bipolar disorder or schizophrenia
  • history of substance abuse
  • severe personal trauma history

研究组 & 干预措施

MIED group

Experimental

The experimental group will participate in a self-guided mindfulness-based intervention for emotional distress, delivered via a WeChat Mini Program platform. The intervention requires daily completion of learning modules and practice exercises. Psychological assessments utilizing self-report questionnaires will be conducted at: baseline (pre-intervention), weekly during the intervention phase (weeks 2 through 7), immediately post-intervention, and at the 1-month follow-up.

干预措施: Mindfulness Intervention for Emotional Distress (self-guided version) (Behavioral)

Waitlist control group

No Intervention

Participants in the waitlist control group will be offered access to the self-guided mindfulness-based intervention after completing all ten assessments (same as the experimental group).

结局指标

主要结局

Weekly changes of Overall Depression Severity and Impairment

时间窗: before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention

The Overall Depression Severity and Impairment Scale is a self-reported questionnaire measuring depression. Scores range from 0 to 20, with higher scores indicating higher levels of depression.

Weekly changes of Overall Anxiety Severity and Impairment

时间窗: before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention

The Overall Anxiety Severity and Impairment Scale is a self-reported questionnaire measuring anxiety. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

Weekly changes of treating thoughts as thoughts

时间窗: before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention

The questionnaire has 1 dimension and contains 5 items on a five-point Likert scale (1=completely compliant, 5=completely non-compliant), with higher scores indicating higher ability to treat ideas as ideas.

Weekly changes of Cognitive flexibility

时间窗: before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention

Cognitive flexibility Inventory is a self-reported questionnaire measuring Cognitive flexibility level.Scores range from 20 to 100, with higher scores indicating higher levels of Cognitive flexibility.

Weekly changes of Brief Experiential Avoidance

时间窗: before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention

Chinese version of the Brief Experiential Avoidance Questionnaire is used to measure Experiential Avoidance.Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.

Weekly changes of Distress Tolerance

时间窗: before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention

Distress Tolerance Scale is used to measure Distress Tolerance. Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance.

Weekly changes of engaging in everyday life

时间窗: before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention

Self-developed scale assessing 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. , 16 items, scores range from 0 to 64, with higher scores indicating higher levels of engaging in everyday life.

次要结局

  • Weekly changes of Psychological Distress(before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention)
  • Weekly changes of depression(before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention)
  • Weekly changes of anxiety(before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention)
  • Changes of trait mindfulness(before the intervention, during weeks 4 and 6 of the intervention, immediately after the intervention, 1 month after the intervention)
  • Weekly changes of Perseverative Thinking(before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention)
  • Weekly changes in perceived stress(before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention)
  • weekly changes of Self-Compassion(before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinghua Liu

Associate Dean

Peking University

研究点 (2)

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