- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05981248
Experiential Avoidance as the Mechanism of Mindfulness Intervention in Reducing Emotional Distress: Daily Dairy Research
August 1, 2023 updated by: Peking University
Experiential Avoidance as the Mechanism of Mindfulness Based Intervention in Reducing Emotional Distress: Daily Dairy Research
This study hopes to:
- explore whether three weeks of MIED could promote experiential avoidance.
- explore experiential avoidance could be a mediation of outcomes of MIED.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mengyao He
- Phone Number: +86 18811317929
- Email: 1901110649@pku.edu.cn
Study Contact Backup
- Name: Xinghua Liu
- Phone Number: +86 13371669818
- Email: xinghua_liu@pku.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly changes of Five Facet Mindfulness Questionnaire during the intervention
Time Frame: 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.
|
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
|
|
Weekly changes of Chinese Perceived Stress Scale during the intervention
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
|
|
Weekly changes of Inner Peace Scale during the intervention
Time Frame: 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.
|
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
|
|
Weekly changes of Depression-Anxiety-Stress Scale during the intervention
Time Frame: 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.
|
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
|
|
Weekly changes of Acceptance and Action Questionnaire-II during the intervention
Time Frame: 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.
|
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
|
|
Weekly changes of Brief Experiential Avoidance Questionnaire during the I intervention
Time Frame: 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.
|
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
|
|
Daily changes of experiential avoidance
Time Frame: 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.
|
once a day in the first three weeks of the intervention
|
|
Daily changes of anxiety
Time Frame: 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.
|
once a day in the first three weeks of the intervention
|
|
Daily changes of depression
Time Frame: 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.
|
once a day in the first three weeks of the intervention
|
|
Daily changes of positive and negative affect
Time Frame: 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.
|
once a day in the first three weeks of the intervention
|
|
Daily stressor exposure
Time Frame: 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.
|
once a day in the first three weeks of the intervention
|
|
Daily mindfulness
Time Frame: 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.
|
once a day in the first three weeks of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xinghua Liu, School of Psychological and Cognitive Sciences, Peking University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 15, 2023
Primary Completion (Estimated)
November 30, 2023
Study Completion (Estimated)
November 30, 2023
Study Registration Dates
First Submitted
August 1, 2023
First Submitted That Met QC Criteria
August 1, 2023
First Posted (Actual)
August 8, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 1, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- E20230815
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emotional Distress
-
Peking UniversityNot yet recruitingEmotional Disorder | Emotional DistressChina
-
Universita di VeronaUniversity of Roma La SapienzaRecruitingDistress, Emotional | Distress, PsychologicalItaly
-
Boise State UniversityNational Institute of General Medical Sciences (NIGMS)Recruiting
-
Peking UniversityNot yet recruitingEmotional DistressChina
-
University of Wisconsin, MadisonActive, not recruiting
-
Peking UniversityCompleted
-
Peking UniversityNot yet recruitingEmotional DistressChina
-
Xinghua LiuNot yet recruiting
-
Peking UniversityNot yet recruitingEmotional DistressChina
-
The University of Hong KongNot yet recruiting
Clinical Trials on Mindfulness Intervention for Emotional Distress
-
Peking UniversityNot yet recruitingEmotional Disorder | Emotional DistressChina
-
Peking UniversityCompleted
-
Peking UniversityNot yet recruiting
-
Peking UniversityNot yet recruitingEmotional DistressChina
-
Peking UniversityNot yet recruitingEmotional DistressChina
-
Peking UniversityNot yet recruitingDepression, Anxiety | Emotional Distress
-
Peking UniversityNot yet recruitingEmotional Distress
-
Peking UniversityThe Second Hospital of Anhui Medical University; The Affiliated Brain Hospital... and other collaboratorsRecruitingDepressive Disorder | Obsessive-Compulsive Disorder | Anxiety Disorders | Eating Disorders | Emotional Disorders | Post-Traumatic Stress Disorder, PTSDChina
-
Xinghua LiuNot yet recruiting
-
Peking UniversityNot yet recruitingEmotional DistressChina