Emotional DistressNCT06722573
Mechanisms of Mindfulness Intervention：Rumination Behavioral Experiments
A study testing Mindfulness Intervention for Emotional Distress(MIED)-normal version in people with Emotional Distress, run by Peking University.
Trial summary
This study hopes to explore whether the changes in rumination exhibited in behavioral experiments mediates the effects of mindfulness intervention on alleviating emotional distress Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Distress
- What is being tested?
- Mindfulness Intervention for Emotional Distress(MIED)-normal version
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2024to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
- - Aged 18-55 years old.
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;
- - Subjects with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
- - Subjects with high risk of suicide.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mechanism of Rumination in the Alleviation of Emotional Distress by Mindfulness-Based Interventions: Evidence from Behavioral Experiments
This study hopes to explore whether the changes in rumination exhibited in behavioral experiments mediates the effects of mindfulness intervention on alleviating emotional distress
Read the detailed description
In recent years, mindfulness-based interventions (MBIs) have seen extensive application in both clinical and non-clinical settings. Studies show that mindfulness training improves emotional regulation and processing, contributing to better emotional health. MBIs have proven effective in reducing anxiety and depression among patients with conditions like multiple sclerosis, enhancing personal well-being, and alleviating chronic pain. Given the mounting evidence supporting its benefits, MBIs have become widely adopted across various settings. Nonetheless, the precise mechanisms through which mindfulness alleviates emotional distress remain poorly understood.
Rumination, a transdiagnostic process, plays a critical role in the development and persistence of emotional distress. Empirical evidence supports the effectiveness of MBIs in reducing rumination. However, the role of rumination in mediating the effects of MBIs on emotional distress remains inconsistent across studies. Kazdin (2007, 2009) outlined criteria for evaluating mechanisms and mediators, yet existing studies lack sufficient evidence to meet these standards. This study aims to explore the mechanistic role of rumination using behavioral experiments, focusing on the consistency criterion
- Conditions
- Emotional Distress
- Being tested
- Mindfulness Intervention for Emotional Distress(MIED)-normal version
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)-normal versionBehavioural
Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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 group | Experimental | Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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)-normal version |
| waitlist control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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; week 3; week 5; immediately after the intervention
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; week 3; week 5; immediately after the intervention
Changes of Rumination-Reflection Questionnaire during the intervention
Rumination-Reflection Questionnaire is a self-reported questionnaire measuring Rumination level.Scores range from 12 to 60, with higher scores indicating higher levels of Rumination.
Measured: pre-intervention; week 3; week 5; immediately after the intervention
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; week 3; week 5; immediately after the intervention
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; week 3; week 5; immediately after the intervention
Changes of the Brief State Rumination Inventory during the intervention
The Brief State Rumination Inventory comprises eight items designed to measure an individual's state rumination tendency at a given moment, encompassing aspects such as the intensity of negative emotions, repetitive thinking, loss of thought control, and the strength of negative affect. The total score, which is derived by summing up the scores of all items, indicates the overall level of the measured construct.
Measured: pre-intervention; week 3; week 5; immediately after the intervention
Changes of the momentary repetitive negative thinking during the intervention
momentary repetitive negative thinking measures the "process" characteristics of rumination, which are traits that exist across diagnostic categories. The scale consists of four items (e.g., "Thoughts come to my mind that I would rather not have"). Each item focuses on a core feature of rumination - repetitiveness, intrusiveness, uncontrollability, and disruptiveness. Items are rated on a 7-point Likert scale, where 1 = not at all and 7 = extremely.
Measured: pre-intervention; week 3; week 5; immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion20 Feb 2025 (estimated)
- Study completion10 Jun 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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 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
- NCT06722573
- Sponsor's protocol ID
- E20241201
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Rumination in the Alleviation of Emotional Distress by Mindfulness-Based Interventions: Evidence from Behavioral Experiments
- ClinicalTrials.gov ID
- NCT06722573
- Acronym / sponsor ID
- E20241201
- Conditions
- Emotional Distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 9 Dec 2024 (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 the changes in rumination exhibited in behavioral experiments mediates the effects of mindfulness intervention on alleviating emotional distress
Detailed description
In recent years, mindfulness-based interventions (MBIs) have seen extensive application in both clinical and non-clinical settings. Studies show that mindfulness training improves emotional regulation and processing, contributing to better emotional health. MBIs have proven effective in reducing anxiety and depression among patients with conditions like multiple sclerosis, enhancing personal well-being, and alleviating chronic pain. Given the mounting evidence supporting its benefits, MBIs have become widely adopted across various settings. Nonetheless, the precise mechanisms through which mindfulness alleviates emotional distress remain poorly understood.
Rumination, a transdiagnostic process, plays a critical role in the development and persistence of emotional distress. Empirical evidence supports the effectiveness of MBIs in reducing rumination. However, the role of rumination in mediating the effects of MBIs on emotional distress remains inconsistent across studies. Kazdin (2007, 2009) outlined criteria for evaluating mechanisms and mediators, yet existing studies lack sufficient evidence to meet these standards. This study aims to explore the mechanistic role of rumination using behavioral experiments, focusing on the consistency criterion
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIED group | Experimental | Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-normal versionMindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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. |
| waitlist control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- - Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
- - Aged 18-55 years old.
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;
- - Subjects with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
- - Subjects with high 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)-normal versionMindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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 group |
Primary outcome
Changes of Five Facet Mindfulness Questionnaire during the intervention
Time frame: pre-intervention; week 3; week 5; immediately after 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.
Changes of 10-item Kessler Psychological Distress Scale during the intervention
Time frame: pre-intervention; week 3; week 5; immediately after 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.
Changes of Rumination-Reflection Questionnaire during the intervention
Time frame: pre-intervention; week 3; week 5; immediately after the intervention
Rumination-Reflection Questionnaire is a self-reported questionnaire measuring Rumination level.Scores range from 12 to 60, with higher scores indicating higher levels of Rumination.
Changes of Overall Anxiety Severity and Impairment Scale during the intervention
Time frame: pre-intervention; week 3; week 5; immediately after 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.
Changes of Overall Depression Severity and Impairment Scale during the intervention
Time frame: pre-intervention; week 3; week 5; immediately after 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.
Changes of the Brief State Rumination Inventory during the intervention
Time frame: pre-intervention; week 3; week 5; immediately after the intervention
The Brief State Rumination Inventory comprises eight items designed to measure an individual's state rumination tendency at a given moment, encompassing aspects such as the intensity of negative emotions, repetitive thinking, loss of thought control, and the strength of negative affect. The total score, which is derived by summing up the scores of all items, indicates the overall level of the measured construct.
Changes of the momentary repetitive negative thinking during the intervention
Time frame: pre-intervention; week 3; week 5; immediately after the intervention
momentary repetitive negative thinking measures the "process" characteristics of rumination, which are traits that exist across diagnostic categories. The scale consists of four items (e.g., "Thoughts come to my mind that I would rather not have"). Each item focuses on a core feature of rumination - repetitiveness, intrusiveness, uncontrollability, and disruptiveness. Items are rated on a 7-point Likert scale, where 1 = not at all and 7 = extremely.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- 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.
Xinghua Liu principal investigator
School of Psychological and Cognitive Sciences, Peking University
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention for Emotional Distress(MIED)-normal version in people with Emotional Distress, run by Peking University.
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: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zitong Xin (+86 13718720771, 2201110738@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Five Facet Mindfulness Questionnaire during the intervention (time frame: pre-intervention; week 3; week 5; immediately after the intervention). The study lists 7 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 Dec 2024.