Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress: Daily Dairy Research

Sponsor
Peking University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05763095
Collaborator
(none)
100
1
2
3.5
28.4

Study Details

Study Description

Brief Summary

This study hopes to:
  1. explore whether three weeks of MIED could promote experiential avoidance.

  2. explore experiential avoidance could be a mediation of outcomes of MIED.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Intervention for Emotional Distress
N/A

Detailed Description

Experiential avoidance refers to individuals resisting experiences or trying to eliminate certain experiences (such as emotions, thoughts, physical feelings, memory and behavioral tendencies, etc.), and trying to adopt corresponding strategies to change these experiences and the situations in which the experiences are generated (Hayes, Wilson, Gifford, Follette, & Strosahl, 1996). Experiential avoidance has been proved to be a maintenance factor for many psychological disorders (Boelen & Reijntjes, 2008), and trying to hide or suppress unpleasant thoughts, feelings and physical feelings will increase the frequency and pain of these same experiences (Gross,1998; Gross,2002; Sloan, 2004; Wegner, 1994). According to some reviews, experiential avoidance is one of the beneficial effects of mindfulness (Brown, Bravo, Roos, & Pearson, 2015; Shapiro et al., 2006). However, no study has examined experiential avoidance as mediator in mindfulness intervention whether in the between-subject or in within-subject level . Therefore, this study uses daily diary research explore the role of experiential avoidance as the effective mechanism of mindfulness intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress: Daily Dairy Research
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: the MIED+TAU group

Intervention description: 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
Mindfulness Intervention for Emotional Distress (MIED) program 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.

No Intervention: the TAU-only group

Outcome Measures

Primary Outcome Measures

  1. Weekly changes of Five Facet Mindfulness Questionnaire during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The Five Facet Mindfulness Questionnaire is a self-reported questionnaire measuring mindfulness levels. Scores range from 39 to 195, with higher scores indicating higher levels of mindfulness.

  2. Weekly changes of Patient Health Questionnaire during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The Patient Health Questionnaire is a self-reported questionnaire measuring the degree of being troubled by various common physical symptoms. Scores range from 0 to 30.

  3. Weekly changes of Chinese Perceived Stress Scale during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The Chinese Perceived Stress Scale is a self-reported questionnaire measuring stress. Scores range from 0 to 56, with higher scores indicating higher levels of stress.

  4. Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The 10-item Kessler Psychological Distress Scale is a self-reported questionnaire measuring distress. Scores range from 10 to 50, with higher scores indicating higher levels of distress.

  5. Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The Overall Anxiety Severity and Impairment Scale is a self-reported questionnaire measuring anxiety. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

  6. Weekly changes of Overall Depression Severity and Impairment Scale during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The Overall Depression Severity and Impairment Scale is a self-reported questionnaire measuring depression. Scores range from 0 to 20, with higher scores indicating higher levels of depression.

  7. Weekly changes of Inner Peace Scale during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The Inner Peace Scale is a self-reported questionnaire measuring peace. Scores range from 0 to 28, with higher scores indicating higher levels of peace.

  8. Weekly changes of Athens Insomnia Scale during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The Athens Insomnia Scale is a self-reported questionnaire measuring sleepy quality. Scores range from 0 to 24, with lower scores indicating higher levels of sleep quality.

Secondary Outcome Measures

  1. Weekly changes of Acceptance and Action Questionnaire-II during the first three weeks of intervention during the intervention [pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention]

    The Acceptance and Action Questionnaire-II is a self-reported questionnaire measuring experiential avoidance. Scores range from 7 to 49, with higher scores indicating higher levels of experiential avoidance.

  2. Weekly changes of Brief Experiential Avoidance Questionnaire during the first three weeks of intervention [pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention]

    The Brief Experiential Avoidance Questionnaire is a self-reported questionnaire measuring experiential avoidance. Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.

  3. Daily changes of experiential avoidance [once a day one week before the intervention; once a day in the first three weeks of the intervention.]

    There are 7 items, 4 of which evaluate the use of specific experiential avoidance strategies today, including distraction , redundant thinking, thought suppression and reassessment and 3 of which evaluate today's broader experiential avoidance. Scores range from 7 to 35, with higher scores indicating higher levels of experiential avoidance.

  4. Daily changes of anxiety [once a day one week before the intervention; once a day in the first three weeks of the intervention.]

    The scale measuring daily anxiety is adapted from the Overall Anxiety Severity and Impairment Scale. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

  5. Daily changes of depression [once a day one week before the intervention; once a day in the first three weeks of the intervention.]

    The scale measuring daily depression is adapted from the Overall Depression Severity and Impairment Scale. Scores range from 0 to 20, with higher scores indicating higher levels of depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Beijing Beijing China 100871

Sponsors and Collaborators

  • Peking University

Investigators

  • Principal Investigator: Xinghua Liu, School of Psychological and Cognitive Sciences, Peking University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xinghua Liu, Director, Peking University
ClinicalTrials.gov Identifier:
NCT05763095
Other Study ID Numbers:
  • E20230315
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 10, 2023