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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPeking University

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: MIED Self-help Intervention GroupExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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