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

NCT07280481 | Recruiting

• 1 other identifier: E20251101
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Anxiety; Emotional Disorders

Outcome Measures

Primary Outcomes (7)

• Weekly changes of Overall Depression Severity and Impairment

  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.

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

• Weekly changes of Overall Anxiety Severity and Impairment

  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.

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

• Weekly changes of treating thoughts as thoughts

  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.

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

• Weekly changes of Cognitive flexibility

  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.

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

• Weekly changes of Brief Experiential Avoidance

  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.

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

• Weekly changes of Distress Tolerance

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

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

• Weekly changes of engaging in everyday life

  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.

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

Secondary Outcomes (7)

• 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

Other Outcomes (1)

• Sensory Processing Sensitivity

  before the intervention

Study Arms (2)

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.

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

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).

Interventions

Mindfulness Intervention for Emotional Distress (self-guided version) BEHAVIORAL

The self-guided version of the Mindfulness Intervention for Emotional Distress (MIED) is a WeChat mini-program that lasts for 49 days. Each day, participants received different materials including (a) an audio recording of mindfulness meditation guidance; (b) learning materials in text or audio; and (c) assignments (for example, informal mindfulness practice, emotion journal, and challenging tasks). These exercises, knowledge and strategies are based on the latest progress in the field of psychological counseling and treatment, and their application in daily life can help alleviate anxiety, depression and other emotional problems.

MIED group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, 100871, China

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences, Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mo Chen

CONTACT

+86 18950308693; 514100919@qq.com

Xinghua Liu

CONTACT

+86 13371669818; xinghua_liu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: November 16, 2025
• Primary Completion: April 28, 2026
• Study Completion (Estimated): May 22, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)