Emotional DistressNCT05763095
Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress: Daily Dairy Research
A study testing Mindfulness Intervention for Emotional Distress in people with Emotional Distress, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotional Distress
- What is being tested?
- Mindfulness Intervention for Emotional Distress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2023to 30 Jun 2023
- 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.
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.
About this study
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.
Read the 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.
- Conditions
- Emotional Distress
- Being tested
- Mindfulness Intervention for Emotional Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Intervention for Emotional DistressBehavioural
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 |
|---|---|---|
| the MIED+TAU group | Experimental | Intervention description: 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 |
| the TAU-only group | No intervention | Not described |
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.
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
Secondary outcomes (5)
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.
Measured: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
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.
Measured: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
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.
Measured: once a day one week before the intervention; once a day in the first three weeks of the intervention.
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.
Measured: once a day one week before the intervention; once a day in the first three weeks of the intervention.
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.
Measured: once a day one week before the intervention; once a day in the first three weeks of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Mar 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (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
- 100 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
- NCT05763095
- Sponsor's protocol ID
- E20230315
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- 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 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress: Daily Dairy Research
- ClinicalTrials.gov ID
- NCT05763095
- Acronym / sponsor ID
- E20230315
- Conditions
- Emotional Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Mar 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 three weeks of MIED could promote experiential avoidance.
- explore experiential avoidance could be a mediation of outcomes of MIED.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the MIED+TAU group | Experimental | Behavioral: Mindfulness Intervention for Emotional DistressIntervention description: 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 | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
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 DistressMindfulness 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 | the 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.
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.
5 secondary outcomes
Weekly changes of Acceptance and Action Questionnaire-II during the first three weeks of intervention during the intervention
Time frame: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Weekly changes of Brief Experiential Avoidance Questionnaire during the first three weeks of intervention
Time frame: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Daily changes of experiential avoidance
Time frame: once a day one week before the intervention; once a day in the first three weeks of the intervention.
Daily changes of anxiety
Time frame: once a day one week before the intervention; once a day in the first three weeks of the intervention.
Daily changes of depression
Time frame: once a day one week before the intervention; once a day in the first three weeks of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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 in people with Emotional Distress, 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 1 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 10 Mar 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 Mengyao He (+86 18811317929, 1901110649@pku.edu.cn), 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 8 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 10 Mar 2023.