Emotional DistressNCT05891015
The Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders
A study testing Mindfulness Intervention for Emotional Distress(MIED) in people with Emotional Distress and Emotional Disorder, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotional Distress, Emotional Disorder
- What is being tested?
- Mindfulness Intervention for Emotional Distress(MIED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2023to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
- Subjects have been diagnosed emotional disorders in the past 6 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University
Beijing, Beijing Municipality, 100871
Xinghua Liu, 13371669818, xinghualiu@pku.edu.cn
Xinghua Liu
About this study
Official title: Exploring the Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders
This study hopes to:
- explore whether offline and online mindfulness interventions can significantly alleviate individual emotional distress,experiential avoidance and improve cognitive flexibility,distress tolerance level.
- 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.
Read the detailed 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.
- Conditions
- Emotional Distress, Emotional Disorder
- Being tested
- Mindfulness Intervention for Emotional Distress(MIED)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Intervention for Emotional Distress(MIED)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MIED+TAU group | Experimental | 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. Receives: Behavioral: Mindfulness Intervention for Emotional Distress(MIED) |
| the TAU-only group | No intervention | treatment as usual (TAU) group consisted of all medicinal and psychological treatments received between baseline and follow-up (about five months). Medicinal treatments included receiving Lorazepam, Olanzapine, Paroxetine Hydrochloride, Sertraline, etc. Psychological treatments included receiving cognitive behavior therapy or psychodynamic therap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary outcomes (4)
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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).
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start20 Jun 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinghua Liu, Peking University
- Investigators
- Xinghua Liu, Principal investigator, School of Psychological and Cognitive Sciences, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891015
- Sponsor's protocol ID
- E20230525
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders
- ClinicalTrials.gov ID
- NCT05891015
- Acronym / sponsor ID
- E20230525
- Conditions
- Emotional Distress, Emotional Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study hopes to:
- explore whether offline and online mindfulness interventions can significantly alleviate individual emotional distress,experiential avoidance and improve cognitive flexibility,distress tolerance level.
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIED+TAU group | Experimental | 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. |
| the TAU-only group | No intervention | –treatment as usual (TAU) group consisted of all medicinal and psychological treatments received between baseline and follow-up (about five months). Medicinal treatments included receiving Lorazepam, Olanzapine, Paroxetine Hydrochloride, Sertraline, etc. Psychological treatments included receiving cognitive behavior therapy or psychodynamic therap |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
- Subjects have been diagnosed emotional disorders in the past 6 months.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MIED+TAU group |
Primary outcome
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.
Weekly changes of Patient Health Questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
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.
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.
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.
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.
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.
Weekly changes of Athens Insomnia Scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of 16items Chinese Version of the Attentional Control Scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Cognitive flexibility Inventory during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Decentralized Questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Beck Depression Inventory during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Beck Anxiety Inventory during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Ruminative Responses Subscale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Emotion Regulation Questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Automatic thoughts questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Cognitive biases questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Thought suppression scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Chinese version of the Brief Experiential Avoidance Questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
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
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.
Weekly changes of Distress Tolerance Scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
4 secondary outcomes
Task Switching Task
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Image rating task
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
The Paced Auditory Serial Addition Task-Computerized; PASAT-C
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Emotional Image Tolerance Task
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinghua Liu principal investigator
School of Psychological and Cognitive Sciences, Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention for Emotional Distress(MIED) in people with Emotional Distress and Emotional Disorder, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Wang (13236502311, zhenzhenwang921@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.