The Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders

Emotional Distress Clinical Trial

Official title:

Exploring the Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05891015
• Other study ID #: E20230525
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: June 2023
• Source: Peking University
• Contact: Zhenzhen Wang
• Phone: 13236502311
• Email: zhenzhenwang921[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study hopes to:

1. explore whether offline and online mindfulness interventions can significantly alleviate individual emotional distress,experiential avoidance and improve cognitive flexibility,distress tolerance level.

2. explore whether cognitive flexibility, distress tolerance and experiential avoidance are the mediators in mindfulness intervention to alleviate emotional distress, and to meet the principles of mechanism.

Description:

Cognitive flexibility is a component of executive function, which refers to the ability to transform cognitive models to adapt to changing environmental needs.Empirical avoidance refers to an individual's resistance to experience or attempts to eliminate certain experiences (such as emotions, thoughts, physical sensations, memories, behavioral tendencies, etc.) and attempts to adopt corresponding strategies to change these experiences and the situations in which they are generated. Distress tolerance to negative emotions is considered to be one of the most important cross-diagnostic predictors of emotional distress.

Studies have shown that people with less cognitive flexibility are less effective at using cognitive restructuring techniques to alleviate emotional distress than those with better cognitive flexibility, which seems to predict the level of cognitive flexibility. Cognitive flexibility levels at the three-month follow-up period were significantly negatively correlated with depression levels and suicidal ideation, and higher levels of cognitive flexibility at baseline significantly predicted lower levels of depression and suicidal ideation in military personnel at the three-month follow-up period. Task switching task was used to measure emotional cognitive flexibility, and explored whether individual differences in cognitive flexibility predicted higher levels of trait anxiety and worry within seven weeks. The results showed that emotional cognitive flexibility in the baseline period seemed to predict anxiety and worry levels after seven weeks.

There is a significant positive correlation between mindfulness and cognitive flexibility. One study compared the changes of cognitive flexibility between the mindfulness based cognitive therapy (MBCT) intervention group and the waiting control group in a randomized controlled study of patients with mild to moderate depression. The results showed that the self-reported cognitive flexibility of the MBCT intervention group was significantly higher than that of the waiting control group, and was significantly correlated with the relief of depressive symptoms.

Some reviews suggest that empirical avoidance is one of the mechanisms for the beneficial effects of mindfulness. Some cross-sectional studies suggest that reduced empirical avoidance is an important mediating factor in the mindfulness to psychopathology pathway, a recent cross-sectional study tested the scales of mindfulness, experiential avoidance and anxiety among college students, and the results showed that experiential avoidance could significantly mediate the relationship between trait mindfulness and anxiety, while trait mindfulness could not mediate the relationship between experiential avoidance and anxiety.

Some distress tolerance related variables, such as uncertainty tolerance and experiential avoidance, were found to mediate between mindfulness or mindfulness interventions and emotional distress.

Generally speaking, exploring the mechanism of the effect of mindfulness-based intervention on emotional distress is helpful to strengthen the positive components of the intervention to optimize the therapeutic effect, distinguish the specificity of treatment from the broader non-specific effect, promote the identification of therapeutic regulators and the matching of therapeutic individuals, and provide information for theoretical development and interpretation of results. With the rapid development of online projects and online platforms, online mindfulness courses begin to receive more and more attention, and show a good application prospect. However, there are few studies on online mindfulness courses at present. In order to better understand the effectiveness of online mindfulness courses, more randomized controlled trials need to be done in the future. Therefore, this study will explore the effect of mindfulness intervention on emotional distress and the mechanism of cognitive flexibility, empirical avoidance and distress tolerance based on the basic criterion to judge the mechanism of psychological intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 15, 2025
• Est. primary completion date: November 15, 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.

• Subjects have been diagnosed emotional disorders in the past 6 months.

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 Disorder
• Emotional Distress
• Mood Disorders

Intervention

Behavioral:
• Mindfulness Intervention for Emotional Distress(MIED)
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 30.0~4 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; 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
Primary	Weekly changes of 16items Chinese Version of the Attentional Control Scale during the intervention	6items Chinese Version of the Attentional Control Scale is a self-reported questionnaire measuring attentional control level.Scores range from 16 to 64, with higher scores indicating higher levels of Attentional Control.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Cognitive flexibility Inventory during the intervention	Cognitive flexibility Inventory is a self-reported questionnaire measuring Cognitive flexibility level.Scores range from 20 to 100, with higher scores indicating higher levels of Cognitive flexibility.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Decentralized Questionnaire during the intervention	Decentralized Questionnaire is a self-reported questionnaire measuring decentralization ability. Scores range from 20 to 100, with higher scores indicating higher levels of Decentralized ability.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Beck Depression Inventory during the intervention	Beck Depression Inventory is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, 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 Beck Anxiety Inventory during the intervention	Beck Anxiety Inventory is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, 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 Ruminative Responses Subscale during the intervention	Ruminative Responses Subscale is a self-reported questionnaire measuring Ruminative Responses level.Scores range from 22 to 88, with higher scores indicating higher levels of Ruminative Responses.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Emotion Regulation Questionnaire during the intervention	Emotion Regulation Questionnaire is a self-reported questionnaire measuring cognitive reappraisal level.Scores range from 6 to 42, with higher scores indicating higher levels of cognitive reappraisal ability.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Automatic thoughts questionnaire during the intervention	Automatic thoughts questionnaire is a self-reported questionnaire measuring Automatic thoughts level.Scores range from 30 to 160, with higher scores indicating higher levels of Automatic thoughts.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Cognitive biases questionnaire during the intervention	Cognitive biases questionnaire is a self-reported questionnaire measuring Cognitive biases level.The score compares the scores of four depression-distortion combinations on a scale of 0 to 23.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Thought suppression scale during the intervention	Thought suppression scale is used to measure the degree of inhibition of an individual's thinking.Scores range from 15 to 75, with higher scores indicating higher levels of thought suppression.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Chinese version of the Brief Experiential Avoidance Questionnaire during the intervention	Chinese version of the Brief Experiential Avoidance Questionnaire scale is used to measure 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
Primary	Weekly changes of Acceptance and Action Questionnaire-II during the intervention	Acceptance and Action Questionnaire-II is used to measure 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
Primary	Weekly changes of Distress Tolerance Scale during the intervention	Distress Tolerance Scale is used to measure Distress Tolerance.Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary	Task Switching Task	The measurement of cognitive flexibility comes from the task switching paradigm, in which participants are required to classify emotional images according to "emotional task rules" or "non-emotional task rules". In emotional task rules, participants are instructed to classify images according to whether the depicted scene is positive or negative. For non-emotional task rules, participants must indicate whether the number of people in the graph is one or none (= 1), or two or more (= 2). Even if there is only a part of a person's body, it counts. The image is taken from the International emotional Image system (International Affective Picture System,IAPS). There are 40 pictures in each category: = 1 person + positive, = 2 + positive, = 1 person + negative, = 2 + negative, a total of 160 pictures. Positive and negative images differ in titer ratings, but are balanced in evocative ratings. Another 20 pictures are used for the practice module.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary	Image rating task	The participants were asked to rate their emotional responses to positive, negative and neutral images presented by the computer, and secretly recorded the rated responses	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary	The Paced Auditory Serial Addition Task-Computerized; PASAT-C	In this task, participants were presented with a series of numbers and were given the task of adding the last two numbers. They were given points for correct answers and unpleasant vocal feedback for incorrect answers.The task consists of four stages: (1) simple stage, which is the control condition of cognitive and motor function; (2) Latency test stage to determine the level of completion of the addition test; (3) pain induced stage, used to induce emotional pain; (4) Pain tolerance stage, used to measure pain tolerance (i.e. the time before task termination).	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary	Emotional Image Tolerance Task	In this task, a series of emotional graphs will be presented on the screen, and the individual needs to first judge whether the picture induces pain. If it does, the duration of the individual's persistence before jumping to the next picture will be taken as the behavioral index of distress tolerance.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention