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

NCT05981248 | Unknown

• 1 other identifier: E20230815
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study hopes to:

1. 1.explore whether three weeks of MIED could promote experiential avoidance.
2. 2.explore experiential avoidance could be a mediation of outcomes of MIED.

Conditions

Emotional Distress

Outcome Measures

Primary Outcomes (15)

• Weekly changes of Five Facet Mindfulness Questionnaire during the 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Weekly changes of Chinese Perceived Stress Scale during the 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Weekly changes of 10-item Kessler Psychological Distress Scale during the 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Weekly changes of Overall Anxiety Severity and Impairment Scale during the 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Weekly changes of Overall Depression Severity and Impairment Scale during the 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Weekly changes of Inner Peace Scale during the 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Weekly changes of Depression-Anxiety-Stress Scale during the 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Weekly changes of Acceptance and Action Questionnaire-II during the 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Weekly changes of Brief Experiential Avoidance Questionnaire during the I 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• Daily changes of experiential avoidance

  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.

  once a day in the first three weeks of the intervention

• Daily changes of anxiety

  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.

  once a day in the first three weeks of the intervention

• Daily changes of depression

  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.

  once a day in the first three weeks of the 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 a day in the first three weeks of the intervention

• Daily stressor exposure

  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.

  once a day in the first three weeks of the intervention

• Daily mindfulness

  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.

  once a day in the first three weeks of the intervention

Study Arms (2)

the MIED+TAU 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

the TAU-only group

NO INTERVENTION

treated as usual

Interventions

Mindfulness Intervention for Emotional Distress BEHAVIORAL

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.

the MIED+TAU group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• 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

Mengyao He

CONTACT

+86 18811317929; 1901110649@pku.edu.cn

Xinghua Liu

CONTACT

+86 13371669818; xinghua_liu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: August 15, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share