The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: Daily Interventions and Daily Assessments

NCT06034613 | Unknown

• 1 other identifier: E20230830
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial seeks to uncover the mechanisms behind the effectiveness of mindfulness-based interventions in reducing emotional distress. Using daily diaries to measure both mediating and outcome variables, the study examines whether these mechanisms precede changes in outcomes. It focuses on the Mindfulness Intervention for Emotional Distress program, which includes four strategies. The current study plans to employ a within-subjects design with daily questionnaires over 63 days, before, during and after the intervention. The aim is to gain insights into how mindfulness interventions work in alleviating emotional distress.

Conditions

Emotional Distress

Outcome Measures

Primary Outcomes (9)

• 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)to10(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 engaging in everyday life

  Self-developed questionnaire, measuring to what extent individuals put efforts and time in engaging in everyday life (e.g., work, social, leisure...), 6 items, scores range from 6 to 54, 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

  measured by Daily distress tolerance scale, four items, scores range from 4 to 20, with higher scores indicating higher levels of distress tolerance.

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

• Daily changes of excessive emotion behaviors

  self-developed scale, measuring to what extent individuals use excessive emotion behaviors to control aversive feelings and emotions, 4 items, scores range from 4 to 20, with higher scores indicating higher levels of using excessive emotion behaviors.

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

• Daily changes of cognitive flexibility/treating thoughts as thoughts

  self-developed questionnaire, measuring to what extent individuals could treat thoughts as psychological phenomenon rather than facts, 4 items, scores range from 4 to 20, with higher scores indicating higher levels of cognitive flexibility.

  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 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 positive and negative affect

  Daily positive and negative affect were measured using the 10-itemInternational Positive and Negative Affect Schedule-Short Form Scale. Scores range from 5 to 25, 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 stress

  Daily perceived stress was assessed with the previously validated four-item version of the Perceived Stress Scale, The PSS measures the degree to which situations in one's life are evaluated as stressful (e.g., "Today, to what extent did you feel confident about your ability to handle your personal problems?"). Participants rated the accuracy of the items using a scale ranging from 1 (very little)to 10 (very much). scores range from 4 to 40.

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

Secondary Outcomes (15)

• daily stressors

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

• pre-post changes of Five Facet Mindfulness Questionnaire

  1 week before the intervention, 1week after the intervention

• pre-post changes of Chinese Perceived Stress Scale

  1 week before the intervention, 1week after the intervention

• pre-post changes of 10-item Kessler Psychological Distress Scale

  1 week before the intervention, 1week after the intervention

• pre-post changes of the Overall Anxiety Severity and Impairment Scale

  1 week before the intervention, 1week after the intervention

Study Arms (1)

mindfulness intervention 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: internet-based mindfulness intervention for emotional distress(iMIED）

Interventions

internet-based mindfulness intervention for emotional distress(iMIED） BEHAVIORAL

The iMIED program integrates the rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth brushing) were adapted from MBIs. In addition, the iMIED program selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks. In total, it took about 30 min per day to finish all the tasks. The program lasted for 49 days.

mindfulness intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Study Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences, Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanjuan Li

CONTACT

+8615992425499; Lyjanice@stu.pku.edu.cn

Xinghua Liu

CONTACT

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: Director

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 13, 2023
• Study Start: September 18, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share