Temporal Dynamics of Mindfulness Intervention for Emotional Distress: Daily Interventions and Assessments

NCT06919406 | Not Yet Recruiting

• 1 other identifier: E20250325
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research aims to adopt a complex systems perspective to thoroughly examine the impact of online mindfulness interventions on changes in emotional distress, with a particular focus on the mechanisms of action. Through a daily diary study design, the study seeks to reveal the complexity and dynamic characteristics of emotional changes and the underlying mechanisms（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement） throughout the intervention process. This research will enrich the theoretical framework of online mental health intervention and provide empirical evidence for optimizing online intervention strategies.

Conditions

Emotional Distress; Depression, Anxiety

Outcome Measures

Primary Outcomes (10)

• Daily 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.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily 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.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily 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, 4 items, scores range from 0 to 16, with higher scores indicating higher levels of engaging in everyday life.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of distress tolerance

  Based on a preliminary study, the items with the highest factor loading from each subscale of the DTS (Simon \& Gaher, 2005) 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 4 to 20, with higher scores indicating greater distress tolerance.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of cognitive flexibility

  Based on a preliminary study, the items with the highest factor loading from each subscale of the DTS (Dennis \&Vander Wal，2010) were chosen to form the Daily Cognitive Flexibility Inventory (DCFI). The DCFI consists of 2 items，that is "I consider multiple options before making a decision"， "When I encounter difficult situations, I feel like I am losing control(reverse scored)". Each item is rated on a scale ranging from 1 (never) to 5 (always). After reverse scoring the second item, the scores are summed, resulting in a total score ranging from 2 to 10, with higher scores indicating greater cognitive flexibility.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of treating thoughts as thoughts

  self-developed questionnaire, measuring to what extent individuals could treat thoughts as psychological phenomena rather than facts, one item, scores range from 1 to 5, with higher scores indicating higher levels of treating thoughts as thoughts.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily 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.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of Emotion

  Daily positive and negative affect were measured using the 10-item International Positive and Negative Affect Schedule-Short Form Scale. Scores range from 0 to 100, with higher scores indicating higher levels of positive/negative affect.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily 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

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of repeative negative thinking

  4 items are adapted from the original Momentary Repetitive Negative Thinking Scale, rated on a scale from 1 (Not at all) to 8 (Very intensely). Total scores range from 4 to 32, where higher scores indicate greater severity of momentary repetitive negative thinking, reflecting more frequent and intense experiences of intrusive, uncontrollable negative thought cycles.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

Secondary Outcomes (13)

• changes of trait mindfulness

  1 week before the intervention, 1 month after the intervention，3 month after the intervention

• changes of Psychological Distress

  1 week before the intervention, 1 month after the intervention，3 month after the intervention

• changes of depression

  1 week before the intervention, 1 month after the intervention，3 month after the intervention

• changes of anxiety

  1 week before the intervention, 1 month after the intervention，3 month after the intervention

• changes of Athens Insomnia Scale

  1 week before the intervention, 1 month after the intervention，3 month after the intervention

Study Arms (1)

MBIs Group

EXPERIMENTAL

provide standard audio instructions for mindfulness exercises, introduce the nature and law of anxiety, depression, and other emotions, the source of anxiety, depression, and other emotional distress, and the strategies and methods to alleviate emotional distress. 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.

Behavioral: Mindfulness Intervention for emotional distress(MIED）

Interventions

Mindfulness Intervention for emotional distress(MIED） BEHAVIORAL

MIED is an eight-week program developed based on MBSR and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. MIED consists of weekly group sessions with daily interactive materials delivered via a WeChat-based mini-program. The group sessions, conducted online, provide structured content and interactive discussions aligned with the weekly themes, for example including psychoeducation on mindfulness, emotions, and emotional distress. Mini Program and lasted 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).

MBIs Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• 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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: April 5, 2025
• Primary Completion: June 20, 2025
• Study Completion: September 10, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share