Emotional DistressNCT06919406
Temporal Dynamics of Mindfulness Intervention for Emotional Distress: Daily Interventions and Assessments
A study testing Mindfulness Intervention for emotional distress(MIED） in people with Emotional Distress and Depression, Anxiety, run by Peking University.
Trial summary
This research aims to adopt a complex systems perspective to thoroughly examine the impact of online mindfulness interventions on changes in emotional distress, with a particular focus on the mechanisms of action. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Emotional Distress, Depression, Anxiety
- 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
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2025to 10 Sep 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 60 years
- All sexes
- No healthy volunteers
- 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
This research aims to adopt a complex systems perspective to thoroughly examine the impact of online mindfulness interventions on changes in emotional distress, with a particular focus on the mechanisms of action. Through a daily diary study design, the study seeks to reveal the complexity and dynamic characteristics of emotional changes and the underlying mechanisms（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement） throughout the intervention process. This research will enrich the theoretical framework of online mental health intervention and provide empirical evidence for optimizing online intervention strategies.
Read the detailed description
Emotional distress refers to psychological discomfort related to emotions-particularly anxiety and depression-as well as the associated suffering and impairments in work and daily life. According to a Gallup survey, approximately one-third of the global population experiences emotional distress (Daly \& Macchia, 2023), with depression, anxiety, and anger being the most prominent aspects. Moreover, the distress associated with worry and sadness has increased significantly from 2009 to 2021. Anxiety disorders and depressive disorders are among the most common mental illnesses worldwide (Kessler et al., 2009; World Health Organization, 2017), and depression is the leading cause of suicide (Ferrari et al., 2014). In China, the lifetime prevalence rates for anxiety disorders and depression are approximately 7.5% and 6.8%, respectively (Y. Huang et al., 2019), with only about 0.5% of patients with depression receiving adequate treatment (Lu et al., 2021). Both anxiety and depressive disorders severely restrict psychosocial functioning and adversely affect normal life. Traditional psychotherapy research has largely been limited to phenomenological descriptions, lacking in-depth exploration of the underlying mechanisms, which in turn constrains the optimization and effectiveness of interventions.
The theories and methods from the field of complex systems can help overcome these limitations by providing a deeper theoretical framework and analytical tools for studying the processes and mechanisms underlying psychotherapeutic effects. In recent years, network analysis and dynamic systems research on psychological interventions for anxiety and depressive disorders have gradually advanced. However, most current studies collect data only before and after the intervention, paying little attention to the dynamic changes during the intervention period and the long-term impact during follow-up. At the network element level, most studies focus on symptom networks, with few incorporating mechanistic variables into their models. Understanding the mechanisms of intervention effects is critical, and this requires including more mechanistic variables in the analysis framework. In conjunction with dynamic systems theory, it is possible to further explore state transitions and their early warning signals. Although early warning signals theoretically hold the potential to predict sudden changes, their practical sensitivity and specificity still need to be improved in order to provide more reliable information for clinical practice.
In summary, existing research suggests that complex network methods hold potential value in clinical practice, warranting further exploration. However, current findings are insufficient to fully and deeply reveal the specific processes underlying psychotherapeutic effects (Holmes et al., 2018). Moreover, the practical utility of complex network methods in clinical settings remains to be verified (Contreras et al., 2019; Schreuder et al., 2023). This is particularly true in the field of mindfulness interventions, where research in this area is still lacking. By adopting a complex systems perspective, incorporating intensive longitudinal measurements, and including mechanistic variables（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement）, this study aims to explore feedback loops with temporal dynamic characteristics. Such an approach will enable researchers to gain a more comprehensive and in-depth understanding of the complexity and dynamics involved in the alleviation of emotional distress such as anxiety and depression.
- Conditions
- Emotional Distress, Depression, Anxiety
- Being tested
- Mindfulness Intervention for emotional distress(MIED）
- Medical subject headings
- Depression, Anxiety Disorders
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
MIED is an eight-week program developed based on MBSR and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. MIED consists of weekly group sessions with daily interactive materials delivered via a WeChat-based mini-program. The group sessions, conducted online, provide structured content and interactive discussions aligned with the weekly themes, for example including psychoeducation on mindfulness, emotions, and emotional distress. Mini Program and lasted for 49 days. Each day, participants received different materials including (a) an audio recording of mindfulness meditation guidance; (b) learning materials in text or audio; and (c) assignments (for example, informal mindfulness practice, emotion journal, and challenging tasks).
| Study group | Role | What they receive |
|---|---|---|
| MBIs Group | Experimental | 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） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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 engaging in everyday life
Self-developed scale assessing the extent to which individuals' daily engagement in life domains (such as work, social interactions, and leisure activities) is affected by physical and psychological discomfort, 4 items, scores range from 0 to 16, with higher scores indicating higher levels of engaging in everyday life.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of distress tolerance
Based on a preliminary study, the items with the highest factor loading from each subscale of the DTS (Simon \& Gaher, 2005) were chosen to form the Daily Distress Tolerance Scale (DDTS). The DDTS consists of four items. Each item is rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree). Scores range from 4 to 20, with higher scores indicating greater distress tolerance.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of cognitive flexibility
Based on a preliminary study, the items with the highest factor loading from each subscale of the DTS (Dennis \&Vander Wal，2010) were chosen to form the Daily Cognitive Flexibility Inventory (DCFI). The DCFI consists of 2 items，that is "I consider multiple options before making a decision"， "When I encounter difficult situations, I feel like I am losing control(reverse scored)". Each item is rated on a scale ranging from 1 (never) to 5 (always). After reverse scoring the second item, the scores are summed, resulting in a total score ranging from 2 to 10, with higher scores indicating greater cognitive flexibility.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of treating thoughts as thoughts
self-developed questionnaire, measuring to what extent individuals could treat thoughts as psychological phenomena rather than facts, one item, scores range from 1 to 5, with higher scores indicating higher levels of treating thoughts as thoughts.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of Experiential Avoidance
Based on a preliminary study, the items with the high factor loading （at least higher than 0.6） from each subscale of the Brief Experiential Avoidance Questionnaire ( Gámez et al, 2013) were chosen to form the Daily Experiential Avoidance Scale (DEAS). The DEAS consists of four items. Each item is rated on a scale ranging from 1 (strongly agree) to 6 (strongly disagree). Scores range from 5 to 30, with higher scores indicating less experiential avoidance.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Daily changes of Emotion
Daily positive and negative affect were measured using the 10-item International Positive and Negative Affect Schedule-Short Form Scale. Scores range from 0 to 100, 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 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) to 10 (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 repeative negative thinking
4 items are adapted from the original Momentary Repetitive Negative Thinking Scale, rated on a scale from 1 (Not at all) to 8 (Very intensely). Total scores range from 4 to 32, where higher scores indicate greater severity of momentary repetitive negative thinking, reflecting more frequent and intense experiences of intrusive, uncontrollable negative thought cycles.
Measured: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Secondary outcomes (13)
changes of trait mindfulness
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: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Psychological 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: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of depression
The Patient Health Questionnaire-9 (PHQ-9) measures the severity of depressive symptoms over the past two weeks. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Measured: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of anxiety
The Generalized Anxiety Disorder-7 (GAD-7) measures the severity of generalized anxiety symptoms over the past two weeks. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Measured: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Athens Insomnia Scale
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: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of engaging in everyday life
Self-developed scale assessing the extent to which individuals' daily engagement in life domains (such as work, social interactions, and leisure activities) is affected by physical and psychological discomfort. , 16 items, scores range from 0 to 64, with higher scores indicating higher levels of engaging in everyday life.
Measured: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Brief Experiential Avoidance Questionnaire
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: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Distress Tolerance Scale
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: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Overall Anxiety Severity and Impairment Scale
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: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Overall Depression Severity and Impairment Scale
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: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of treating thoughts as thoughts
The questionnaire has 1 dimension and contains 5 items on a five-point Likert scale (1=completely compliant, 5=completely non-compliant), with higher scores indicating higher ability to treat ideas as ideas.
Measured: 1 week before the intervention, the onset of the intervention，1 week after the onset of the intervention，2 week after the onset of the intervention， 1 month after the intervention，3 month after the intervention
changes of Cognitive flexibility Inventory
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: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Perseverative Thinking Questionnaire
Perseverative Thinking Questionnaire,16 items, scores range from 0 to 60, with higher scores indicating greater severity of repetitive negative thinking (RNT).
Measured: 1 week before the intervention, 1 month after the intervention，3 month 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 Apr 2025
- Study start5 Apr 2025 (estimated)
- Primary completion20 Jun 2025 (estimated)
- Study completion10 Sep 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
- Not applicable
- Intervention model
- Single group
- 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
- NCT06919406
- Sponsor's protocol ID
- E20250325
- Status last verified
- Mar 2025
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Dynamics of Mindfulness Intervention for Emotional Distress: Daily Interventions and Assessments
- ClinicalTrials.gov ID
- NCT06919406
- Acronym / sponsor ID
- E20250325
- Conditions
- Emotional Distress, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 5 Apr 2025 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 9 Apr 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 research aims to adopt a complex systems perspective to thoroughly examine the impact of online mindfulness interventions on changes in emotional distress, with a particular focus on the mechanisms of action. Through a daily diary study design, the study seeks to reveal the complexity and dynamic characteristics of emotional changes and the underlying mechanisms（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement） throughout the intervention process. This research will enrich the theoretical framework of online mental health intervention and provide empirical evidence for optimizing online intervention strategies.
Detailed description
Emotional distress refers to psychological discomfort related to emotions-particularly anxiety and depression-as well as the associated suffering and impairments in work and daily life. According to a Gallup survey, approximately one-third of the global population experiences emotional distress (Daly \& Macchia, 2023), with depression, anxiety, and anger being the most prominent aspects. Moreover, the distress associated with worry and sadness has increased significantly from 2009 to 2021. Anxiety disorders and depressive disorders are among the most common mental illnesses worldwide (Kessler et al., 2009; World Health Organization, 2017), and depression is the leading cause of suicide (Ferrari et al., 2014). In China, the lifetime prevalence rates for anxiety disorders and depression are approximately 7.5% and 6.8%, respectively (Y. Huang et al., 2019), with only about 0.5% of patients with depression receiving adequate treatment (Lu et al., 2021). Both anxiety and depressive disorders severely restrict psychosocial functioning and adversely affect normal life. Traditional psychotherapy research has largely been limited to phenomenological descriptions, lacking in-depth exploration of the underlying mechanisms, which in turn constrains the optimization and effectiveness of interventions.
The theories and methods from the field of complex systems can help overcome these limitations by providing a deeper theoretical framework and analytical tools for studying the processes and mechanisms underlying psychotherapeutic effects. In recent years, network analysis and dynamic systems research on psychological interventions for anxiety and depressive disorders have gradually advanced. However, most current studies collect data only before and after the intervention, paying little attention to the dynamic changes during the intervention period and the long-term impact during follow-up. At the network element level, most studies focus on symptom networks, with few incorporating mechanistic variables into their models. Understanding the mechanisms of intervention effects is critical, and this requires including more mechanistic variables in the analysis framework. In conjunction with dynamic systems theory, it is possible to further explore state transitions and their early warning signals. Although early warning signals theoretically hold the potential to predict sudden changes, their practical sensitivity and specificity still need to be improved in order to provide more reliable information for clinical practice.
In summary, existing research suggests that complex network methods hold potential value in clinical practice, warranting further exploration. However, current findings are insufficient to fully and deeply reveal the specific processes underlying psychotherapeutic effects (Holmes et al., 2018). Moreover, the practical utility of complex network methods in clinical settings remains to be verified (Contreras et al., 2019; Schreuder et al., 2023). This is particularly true in the field of mindfulness interventions, where research in this area is still lacking. By adopting a complex systems perspective, incorporating intensive longitudinal measurements, and including mechanistic variables（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement）, this study aims to explore feedback loops with temporal dynamic characteristics. Such an approach will enable researchers to gain a more comprehensive and in-depth understanding of the complexity and dynamics involved in the alleviation of emotional distress such as anxiety and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBIs Group | Experimental | Behavioral: Mindfulness Intervention for emotional distress(MIED）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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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）MIED is an eight-week program developed based on MBSR and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. MIED consists of weekly group sessions with daily interactive materials delivered via a WeChat-based mini-program. The group sessions, conducted online, provide structured content and interactive discussions aligned with the weekly themes, for example including psychoeducation on mindfulness, emotions, and emotional distress. Mini Program and lasted for 49 days. Each day, participants received different materials including (a) an audio recording of mindfulness meditation guidance; (b) learning materials in text or audio; and (c) assignments (for example, informal mindfulness practice, emotion journal, and challenging tasks). | Behavioural | MBIs Group |
Primary outcome
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 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 engaging in everyday life
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Self-developed scale assessing the extent to which individuals' daily engagement in life domains (such as work, social interactions, and leisure activities) is affected by physical and psychological discomfort, 4 items, scores range from 0 to 16, with higher scores indicating higher levels of engaging in everyday life.
Daily changes of distress tolerance
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Based on a preliminary study, the items with the highest factor loading from each subscale of the DTS (Simon \& Gaher, 2005) were chosen to form the Daily Distress Tolerance Scale (DDTS). The DDTS consists of four items. Each item is rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree). Scores range from 4 to 20, with higher scores indicating greater distress tolerance.
Daily changes of cognitive flexibility
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Based on a preliminary study, the items with the highest factor loading from each subscale of the DTS (Dennis \&Vander Wal，2010) were chosen to form the Daily Cognitive Flexibility Inventory (DCFI). The DCFI consists of 2 items，that is "I consider multiple options before making a decision"， "When I encounter difficult situations, I feel like I am losing control(reverse scored)". Each item is rated on a scale ranging from 1 (never) to 5 (always). After reverse scoring the second item, the scores are summed, resulting in a total score ranging from 2 to 10, with higher scores indicating greater cognitive flexibility.
Daily changes of treating thoughts as thoughts
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
self-developed questionnaire, measuring to what extent individuals could treat thoughts as psychological phenomena rather than facts, one item, scores range from 1 to 5, with higher scores indicating higher levels of treating thoughts as thoughts.
Daily changes of Experiential Avoidance
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Based on a preliminary study, the items with the high factor loading （at least higher than 0.6） from each subscale of the Brief Experiential Avoidance Questionnaire ( Gámez et al, 2013) were chosen to form the Daily Experiential Avoidance Scale (DEAS). The DEAS consists of four items. Each item is rated on a scale ranging from 1 (strongly agree) to 6 (strongly disagree). Scores range from 5 to 30, with higher scores indicating less experiential avoidance.
Daily changes of Emotion
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-item International Positive and Negative Affect Schedule-Short Form Scale. Scores range from 0 to 100, with higher scores indicating higher levels of positive/negative affect.
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) to 10 (often). scores range from 4 to 40, with higher scores indicating higher levels of mindful responding
Daily changes of repeative negative thinking
Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
4 items are adapted from the original Momentary Repetitive Negative Thinking Scale, rated on a scale from 1 (Not at all) to 8 (Very intensely). Total scores range from 4 to 32, where higher scores indicate greater severity of momentary repetitive negative thinking, reflecting more frequent and intense experiences of intrusive, uncontrollable negative thought cycles.
13 secondary outcomes
changes of trait mindfulness
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Psychological Distress
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of depression
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of anxiety
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Athens Insomnia Scale
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of engaging in everyday life
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Brief Experiential Avoidance Questionnaire
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Distress Tolerance Scale
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Overall Anxiety Severity and Impairment Scale
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Overall Depression Severity and Impairment Scale
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of treating thoughts as thoughts
Time frame: 1 week before the intervention, the onset of the intervention，1 week after the onset of the intervention，2 week after the onset of the intervention， 1 month after the intervention，3 month after the intervention
changes of Cognitive flexibility Inventory
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
changes of Perseverative Thinking Questionnaire
Time frame: 1 week before the intervention, 1 month after the intervention，3 month after the intervention
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 Apr 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 and Depression, Anxiety, 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 9 Apr 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 Mo Chen (+86 18950308693, 514100919@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 10 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 Apr 2025.