The Dynamic Mechanism of Mindfulness Intervention for Emotional Distress (MIED) Based on Ecological Moment Measurement

NCT07809737 | Not Yet Recruiting

• 1 other identifier: E20260827
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Emotional Distress; Depression; Anxiety

Outcome Measures

Primary Outcomes (9)

• changes of depression

  Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.

  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 anxiety

  Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

  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 mindfulness

  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

  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.

  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 engaging in life

  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).

  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 physical distress intolerance

  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.

  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 experiential avoidance

  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.

  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 rumination

  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.

  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 negative emotion

  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.

  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

Study Arms (1)

MIED Self-help Intervention Group

EXPERIMENTAL

Participants receive a 49-day self-help intervention delivered via a Mini Program.

Behavioral: Mindfulness Intervention for emotional distress(MIED）

Interventions

Mindfulness Intervention for emotional distress(MIED） BEHAVIORAL

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).

MIED Self-help Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

MO CHEN

CONTACT

86 +18950308693; amor_chen@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Associate Professor

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 9, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share