Experiential Avoidance as the Mechanism of Mindfulness Intervention in Reducing Emotional Distress: Daily Dairy Research

Sponsor
Peking University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05981248
Collaborator
(none)
200
2
3.5

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 :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Experiential Avoidance as the Mechanism of Mindfulness Based Intervention in Reducing Emotional Distress: Daily Dairy Research
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: the MIED+TAU group

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

treated as usual

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 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Weekly changes of Depression-Anxiety-Stress Scale during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]

    The Depression-Anxiety-Stress Scale is a self-reported questionnaire measuring psychological health. Scores range from 0 to 63, with higher scores indicating higher levels of depression, anxiety or stress.

  8. Weekly changes of Acceptance and Action Questionnaire-II during the intervention [pre-intervention; weekly during the 7-week intervention; after the 7-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.

  9. Weekly changes of Brief Experiential Avoidance Questionnaire during the I intervention [pre-intervention; weekly during the 7-week intervention; after the 7-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.

  10. Daily changes of experiential avoidance [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.

  11. Daily changes of anxiety [once a day in the first three weeks of the intervention]

    Daily anxiety was assessed using a 6-item shortened version of the State-Trait Anxiety Inventory. Scores range from 6 to 24, with higher scores indicating higher levels of anxiety.

  12. Daily changes of depression [once a day in the first three weeks of the intervention]

    Daily depressive symptoms were measured by a 10-item modified version of the Centre for Epidemiologic Studies Depressive Scale with item wordings adapted to include the word 'today' and the instructions modified. Scores range from 0 to 30, with higher scores indicating higher levels of depression.

  13. Daily changes of positive and negative affect [once a day in the first three weeks of the intervention]

    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.

  14. Daily stressor exposure [once a day in the first three weeks of the intervention]

    Daily stressor exposure was measured using a 7-item scale from the Daily Inventory of Stressful Events. if at least one stressor event was experienced by the participant within the day, it was then categorized as a stressor day. If no stressor events were experienced on the day, it was categorized as a non-stressor day.

  15. Daily mindfulness [once a day in the first three weeks of the intervention]

    5 items with the highest factor from each subscale of the Five-Facet Mindfulness Questionnaire were chosen. Scores range from 5 to 25, with higher scores indicating higher levels of mindfulness.

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

No locations specified.

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:
Peking University
ClinicalTrials.gov Identifier:
NCT05981248
Other Study ID Numbers:
  • E20230815
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Jul 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 Aug 8, 2023