Emotional DistressNCT06785259
Mindfulness Interventions and Emotional Distress: A Daily Study
A study testing Mindfulness Intervention for Emotional Distress(MIED) in people with Emotional Distress, run by Peking University.
Trial summary
This study hopes to explore whether the changes in rumination exhibited in Daily Diary mediates the effects of mindfulness intervention on alleviating emotional distress Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Distress
- 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
- 120 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2025to 20 May 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 65 years
- All sexes
- Healthy volunteers accepted
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Complex Systems Analysis of the Impact of Mindfulness Intervention on Emotional Distress: A Study of Daily Interventions and Daily Diary
This study hopes to explore whether the changes in rumination exhibited in Daily Diary mediates the effects of mindfulness intervention on alleviating emotional distress
Read the detailed description
This study will employ a daily diary research design to collect detailed time-series data, capturing the dynamic evolution of participants' emotional changes. This approach not only facilitates the provision of robust evidence regarding the effects of mindfulness interventions but also offers valuable insights for refining and personalizing future intervention strategies.
Mindfulness involves observing one's current state of mind with an open, non-judgmental attitude, including awareness of breathing, bodily sensations, and actions (Wielgosz et al., 2019). With the widespread use of the internet and smartphones, there has been a rapid increase in the demand for mental health services, leading to the emergence of lightweight online mindfulness intervention programs that have garnered increasing attention (Taylor et al., 2021).
Mindfulness-based interventions (MBIs) can positively impact various aspects of individuals' lives (Wielgosz et al., 2019), including physical and mental health, cognitive abilities, emotions, and interpersonal relationships. Regular mindfulness training often leads to healthier behaviors, such as reduced substance abuse, decreased self-harm and suicidal behaviors, and alleviation of eating disorder symptoms (Schuman-Olivier et al., 2020). MBIs are applicable to both clinical and non-clinical populations: they benefit not only patients with physical or mental illnesses (Carlson, 2012; Turgon et al., 2019) but also those experiencing behavioral or emotional distress (Ju, 2022; Ma et al., 2018).
In addition to studying the efficacy of interventions, it is crucial to explore their mechanisms of action. Traditional methods of mechanism research have provided some evidence, defining mechanisms as "processes responsible for change," while mediators are "statistical explanations of the relationship between independent and dependent variables" (Kazdin, 2007, p.3). Currently, researchers have begun to investigate the mechanisms underlying mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) (Batink et al., 2013; Geschwind et al., 2011; Alsubaie et al., 2017).
However, traditional theoretical frameworks and analytical methods cannot adequately explain or capture sudden, nonlinear changes during the intervention process. Such phenomena can be better understood through complex systems theory. By applying complex network theory and methods, we can gain new insights into the complexity and dynamics of changes during the intervention process, identify intervention targets, uncover potential core targets, predict abrupt changes, and provide evidence for optimizing intervention targets and timing, thereby enhancing the effectiveness of intervention programs. Complex systems theory holds great promise for understanding the mechanisms of psychological interventions, yet few studies have examined the complex and dynamic changes in psychological variables during interventions from this perspective in the field of mindfulness research.
Therefore, in this study, we will first focus on several potential mechanism variables, specifically rumination, using the framework and analytical tools of complex systems theory to examine the complexity and dynamics of changes during online mindfulness interventions.
An increasing number of researchers are beginning to view rumination as a transdiagnostic pathological process closely related to the development and maintenance of various emotional disturbances (Ehring \& Watkins, 2008; Nolen-Hoeksema \& Watkins, 2011; Watkins \& Roberts, 2020). Rumination is associated with multiple emotional disorders and their comorbid conditions, including depressive disorders and anxiety disorders (Nolen-Hoeksema, 2000; Nolen-Hoeksema, Wisco, \& Lyubomirsky, 2008). Rumination is a negative thought pattern characterized by repetitive negative thinking about problems, the causes, meanings, and consequences of distress (Watkins, 2008). It typically involves negative self-evaluations and is considered a maladaptive emotion regulation strategy linked to reduced well-being (Brans et al., 2013).
In summary, most current mechanism studies have not rigorously characterized the processes underlying mindfulness interventions using multiple measurement points and appropriate statistical methods, nor have they simultaneously examined the complexity and dynamics of multiple mechanism variables and outcome variables in mindfulness interventions. Therefore, conducting daily diary research will provide valuable evidence for a deeper and more comprehensive understanding of how interventions work.
- Conditions
- Emotional Distress
- 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 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily changes of mindfulness
The Daily Mindfulness Response Scale measures the frequency with which one returns to a nonjudgmental and unconditionally receptive present moment awareness during the day. Each item is rated on a scale ranging from 1 (rarely)to10(often). scores range from 4 to 40, with higher scores indicating higher levels of mindful responding
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of rumination
measured by Momentary repetitive negative thinking, night items, scores range from 9 to 63, with higher scores indicating higher levels of reprtitive negative thinking.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of positive and negative affect
Daily positive and negative affect were measured using the 10-itemInternational Positive and Negative Affect Schedule-Short Form Scale. Scores range from 5 to 25, with higher scores indicating higher levels of positive/negative affect.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of emotional distress
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: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
daily changes of anxiety
Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
daily changes of depression
Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of the Brief State Rumination Inventory
he 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: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start18 Jan 2025 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion20 May 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT06785259
- Sponsor's protocol ID
- E20250107
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 21 Jan 2025
- 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 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Systems Analysis of the Impact of Mindfulness Intervention on Emotional Distress: A Study of Daily Interventions and Daily Diary
- ClinicalTrials.gov ID
- NCT06785259
- Acronym / sponsor ID
- E20250107
- Conditions
- Emotional Distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 18 Jan 2025 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 21 Jan 2025 (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 Daily Diary mediates the effects of mindfulness intervention on alleviating emotional distress
Detailed description
This study will employ a daily diary research design to collect detailed time-series data, capturing the dynamic evolution of participants' emotional changes. This approach not only facilitates the provision of robust evidence regarding the effects of mindfulness interventions but also offers valuable insights for refining and personalizing future intervention strategies.
Mindfulness involves observing one's current state of mind with an open, non-judgmental attitude, including awareness of breathing, bodily sensations, and actions (Wielgosz et al., 2019). With the widespread use of the internet and smartphones, there has been a rapid increase in the demand for mental health services, leading to the emergence of lightweight online mindfulness intervention programs that have garnered increasing attention (Taylor et al., 2021).
Mindfulness-based interventions (MBIs) can positively impact various aspects of individuals' lives (Wielgosz et al., 2019), including physical and mental health, cognitive abilities, emotions, and interpersonal relationships. Regular mindfulness training often leads to healthier behaviors, such as reduced substance abuse, decreased self-harm and suicidal behaviors, and alleviation of eating disorder symptoms (Schuman-Olivier et al., 2020). MBIs are applicable to both clinical and non-clinical populations: they benefit not only patients with physical or mental illnesses (Carlson, 2012; Turgon et al., 2019) but also those experiencing behavioral or emotional distress (Ju, 2022; Ma et al., 2018).
In addition to studying the efficacy of interventions, it is crucial to explore their mechanisms of action. Traditional methods of mechanism research have provided some evidence, defining mechanisms as "processes responsible for change," while mediators are "statistical explanations of the relationship between independent and dependent variables" (Kazdin, 2007, p.3). Currently, researchers have begun to investigate the mechanisms underlying mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) (Batink et al., 2013; Geschwind et al., 2011; Alsubaie et al., 2017).
However, traditional theoretical frameworks and analytical methods cannot adequately explain or capture sudden, nonlinear changes during the intervention process. Such phenomena can be better understood through complex systems theory. By applying complex network theory and methods, we can gain new insights into the complexity and dynamics of changes during the intervention process, identify intervention targets, uncover potential core targets, predict abrupt changes, and provide evidence for optimizing intervention targets and timing, thereby enhancing the effectiveness of intervention programs. Complex systems theory holds great promise for understanding the mechanisms of psychological interventions, yet few studies have examined the complex and dynamic changes in psychological variables during interventions from this perspective in the field of mindfulness research.
Therefore, in this study, we will first focus on several potential mechanism variables, specifically rumination, using the framework and analytical tools of complex systems theory to examine the complexity and dynamics of changes during online mindfulness interventions.
An increasing number of researchers are beginning to view rumination as a transdiagnostic pathological process closely related to the development and maintenance of various emotional disturbances (Ehring \& Watkins, 2008; Nolen-Hoeksema \& Watkins, 2011; Watkins \& Roberts, 2020). Rumination is associated with multiple emotional disorders and their comorbid conditions, including depressive disorders and anxiety disorders (Nolen-Hoeksema, 2000; Nolen-Hoeksema, Wisco, \& Lyubomirsky, 2008). Rumination is a negative thought pattern characterized by repetitive negative thinking about problems, the causes, meanings, and consequences of distress (Watkins, 2008). It typically involves negative self-evaluations and is considered a maladaptive emotion regulation strategy linked to reduced well-being (Brans et al., 2013).
In summary, most current mechanism studies have not rigorously characterized the processes underlying mindfulness interventions using multiple measurement points and appropriate statistical methods, nor have they simultaneously examined the complexity and dynamics of multiple mechanism variables and outcome variables in mindfulness interventions. Therefore, conducting daily diary research will provide valuable evidence for a deeper and more comprehensive understanding of how interventions work.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIED group | Experimental | Behavioral: Mindfulness Intervention for Emotional Distress(MIED)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- 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 Distress(MIED)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. | Behavioural | MIED group |
Primary outcome
Daily changes of mindfulness
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
The Daily Mindfulness Response Scale measures the frequency with which one returns to a nonjudgmental and unconditionally receptive present moment awareness during the day. Each item is rated on a scale ranging from 1 (rarely)to10(often). scores range from 4 to 40, with higher scores indicating higher levels of mindful responding
Daily changes of rumination
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measured by Momentary repetitive negative thinking, night items, scores range from 9 to 63, with higher scores indicating higher levels of reprtitive negative thinking.
Daily changes of positive and negative affect
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily positive and negative affect were measured using the 10-itemInternational Positive and Negative Affect Schedule-Short Form Scale. Scores range from 5 to 25, with higher scores indicating higher levels of positive/negative affect.
Daily changes of emotional distress
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-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.
daily changes of anxiety
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.
daily changes of depression
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.
Daily changes of the Brief State Rumination Inventory
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
he 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.
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 21 Jan 2025.
- 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) 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 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: opening soon, as of the sponsor's last update on 21 Jan 2025. 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?
Daily changes of mindfulness (time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-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 21 Jan 2025.