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Not yet recruitingNCT07809737Updated Sep 9, 2026

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

An interventional study of Mindfulness Intervention for emotional distress(MIED) in Emotional Distress, Depression and Anxiety, sponsored by Peking University. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Peking University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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?

02

Conditions studied

  • Emotional Distress
  • Depression
  • Anxiety
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    MIED Self-help Intervention Group

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

    Behavioral: Mindfulness Intervention for emotional distress(MIED)

Interventions

  • BehavioralMindfulness Intervention for emotional distress(MIED)

    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).

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: 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. 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

    Time frame: 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. 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.

    Time frame: 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

  5. 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).

    Time frame: 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

  6. 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.

    Time frame: 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

  7. 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.

    Time frame: 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

  8. 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.

    Time frame: 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

  9. 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.

    Time frame: 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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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07809737
Lead sponsor
Peking University
Responsible party
Xinghua Liu (Tenured Associate Professor, Peking University) — Principal investigator
First posted
Sep 9, 2026
Start date
Sep 5, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 22, 2026 (estimated)
Last update
Sep 9, 2026

Study contacts

MO CHEN
Contact
amor_chen@foxmail.com
86 +18950308693

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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