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

Emotional Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05763095
• Other study ID #: E20230315
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2023
• Source: Peking University
• Contact: Mengyao He
• Phone: +86 18811317929
• Email: 1901110649[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Distress

Intervention

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.

Locations

Country	Name	City	State
China	Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Weekly changes of Patient Health Questionnaire during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Weekly changes of Athens Insomnia Scale during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary	Weekly changes of Acceptance and Action Questionnaire-II during the first three weeks of intervention 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; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Secondary	Weekly changes of Brief Experiential Avoidance Questionnaire during the first three weeks of 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; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Secondary	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 one week before the intervention; once a day in the first three weeks of the intervention.
Secondary	Daily changes of anxiety	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.	once a day one week before the intervention; once a day in the first three weeks of the intervention.
Secondary	Daily changes of depression	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.	once a day one week before the intervention; once a day in the first three weeks of the intervention.