Experiential Avoidance as Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress

Emotional Distress Clinical Trial

Official title:

Experiential Avoidance as Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789160
• Other study ID #: E20220718
• Status: Completed
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study hopes to explore whether experiential avoidance could be a mediator between mindfulness-based interventions and emotional distress.

Description:

The improvement of emotional distress by mindfulness intervention has been supported by a large number of empirical studies. For example, the meta-analysis of the effect of MBSR on people with chronic diseases shows that both anxiety (Hedges' g = 0.47) and depression (Hedges' g = 0.26) in mindfulness intervention group are reduced. Mindfulness-based interventions also have good intervention effect on anxiety (Hedges' g = 0.67) and depression (Hedges' g = 0.48) in the general population. Unfortunately, few studies have used the correct methods to test the mechanism of mindfulness-based interventions in mediation analysis or experiments. Experiential avoidance refers to the unwillingness to keep in touch with specific personal experiences (such as physical feelings, emotions, thinking, memory, and behavioral tendencies), and to take measures to change the form or frequency of these experiences, as well as the situations that trigger these experiences. Experiential avoidance often has only a short-term effect, but it has no effect in the long run, and may even be unfavorable. The paradox of experiential avoidance is that trying to hide or suppress unpleasant thoughts, feelings and physical feelings will increase the frequency and pain of these same experiences, and will enhance the feeling that they are unreal or out of touch with themselves. In addition, long-term experiential avoidance will interfere with the fun of being completely immersed in any activity, leading to the reduction of the frequency of positive events and the suppression of positive emotions. Some reviews believe that experiential avoidance is one of the mechanisms of beneficial effects brought by mindfulness. Some cross-sectional studies show that the reduction of empirical avoidance is an important intermediary factor in the path of mindfulness to psychopathology . However, no research has directly tested the mediating role of experiential avoidance in mindfulness-based intervention to alleviate emotional distress, which is also the problem that this study wants to explore. According to Kazdin(2007), in order to prove the timeline principle, that is, the change of experiential avoidance is before the change of emotional distress, we will measure the above variables every week during the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• 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;

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; immediately 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.; 0~4 scores: no physical symptoms; 5~9 scores: mild physical symptoms; 10~14 scores: moderate physical symptoms; 15~30 scores: severe physical symptoms.	pre-intervention; weekly during the 7-week intervention; immediately 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; immediately 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; immediately 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; immediately 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; immediately 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; immediately 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; immediately after the 7-week intervention
Secondary	Weekly changes of Brief Experiential Avoidance Questionnaire during the 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; immediately after the 7-week intervention
Secondary	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; immediately after the 7-week intervention
Secondary	Weekly changes of the 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 lower levels of psychological health.	pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention