Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical study is to learn how Mindfulness Intervention for Emotional Distress (MIED) helps people with emotional distress and how their symptoms and psychological patterns change over time.
The main questions it aims to answer are:
Participants will:
This study includes about 500 adults aged 18 and older who feel anxious, depressed, or emotionally distressed but have no major psychiatric disorders. By tracking weekly changes, the research aims to identify how mindfulness intervention leads to emotional improvement and which skills play the most important roles in that process.
Research Background Traditional psychotherapy research tends to emphasize description rather than explanation, relying excessively on data accumulation while neglecting theoretical construction and development (Gelo & Salvatore, 2016). Complex network theory and its related methods can overcome the limitations of traditional empiricism, providing a deeper theoretical framework and analytical tools for psychotherapy research. By applying complex network methods, it becomes possible to comprehensively analyze the multidimensional and multicausal dynamic relationships between symptoms or psychological variables during psychotherapy, thus gaining a clearer understanding of the processes underlying the development and recovery of mental health problems.
Network analysis can reveal the direct connections between different variables (Borsboom, 2017), rather than relying solely on changes in overall mean levels. Combined with multi-time-point measurement designs, researchers can track gradual changes in relationships between variables during the intervention, thereby identifying which associations change first in the therapeutic process and which variables may play key roles throughout the intervention (Blanken et al., 2019; Cervin et al., 2020). This contributes to an in-depth exploration of the mechanisms underlying psychological interventions and a more comprehensive understanding of change patterns in the therapeutic process.
Mindfulness-Based Interventions (MBIs) are a form of psychotherapy whose effectiveness has been widely validated (Wielgosz et al., 2019). Through regular mindfulness practice, individuals tend to develop healthier behavioral patterns, such as reduction of substance abuse, self-harm, suicidal behaviors, and eating disorder symptoms (Schuman-Olivier et al., 2020). Mindfulness-centered interventions are applicable to both clinical and non-clinical populations: not only to patients with physical or mental disorders (Carlson, 2012; Turgon et al., 2019), but also to individuals experiencing behavioral or emotional distress (Ju, 2022; Ma et al., 2018), all of whom can benefit from short-term or long-term mindfulness practice. Both traditional face-to-face formats and online mindfulness programs have been shown to improve emotional well-being and enhance quality of life (Li et al., 2025; Taylor et al., 2021). The convenience and accessibility of online interventions, in particular, enable more people experiencing emotional distress to receive continuous psychological support.
In addition to studying the efficacy of interventions, understanding the mechanisms of mindfulness interventions is equally important. Many researchers have begun to explore the mechanisms underlying Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) (Gu et al., 2015; Maloney et al., 2024). Traditional mechanism studies are mostly based on mediation models that conceptualize mechanisms as static variables linking interventions and outcomes (Kazdin, 2007), making it difficult to capture the dynamic interactions among multiple variables (such as distress tolerance, experiential avoidance, and cognitive flexibility) during the intervention process. The cross-diagnostic interactions and longitudinal predictive relationships between these transdiagnostic factors and anxiety or depressive symptoms during intervention remain unclear.
Therefore, to gain a deeper understanding of how mindfulness interventions "take effect" and the "change patterns" that occur during the process, this study is based on Liu's (2024) Rhombus Model of Psychopathology in Emotional Distress. Using a randomized controlled trial design, weekly measurements will be conducted on individuals participating in an online mindfulness intervention. By applying network analysis methods, this study will focus on the weekly dynamics of psychopathological and symptom networks formed by key mechanism variables-distress tolerance, experiential avoidance, life engagement, and cognitive flexibility-as well as anxiety and depression symptoms during the intervention. The aim is to systematically reveal the dynamic processes and core pathways through which mindfulness interventions drive psychological change.
Summary and Outlook
Summary of current research on mindfulness programs and main findings:
Based on the above summary, the following issues need to be further explored:
Based on the above summary, the overall objective of this study is to reveal the weekly dynamic characteristics and key pathways of psychological mechanisms and symptom networks among individuals with emotional distress during mindfulness intervention. The specific objectives are as follows:
Research Design The participants in this study will be adults. Participants will be recruited voluntarily and screened based on questionnaires included in the informed consent process. Inclusion criteria: 18 years or older, experiencing emotional distress such as depression or anxiety (Kessler-10 score > 21), no prior experience with mindfulness meditation, no current self-harm or suicidal risk, no bipolar disorder or schizophrenia, no history of substance abuse, and no severe personal trauma history.
After being randomly assigned to an intervention group or a waitlist control group, participants in the intervention group will take part in the self-guided mindfulness intervention for emotional distress, with a total of ten assessments: before the intervention, after each week during the intervention, after the intervention, and one week after one month post-intervention. The questionnaires will include, but are not limited to, measures of mindfulness, distress tolerance, experiential avoidance, cognitive flexibility, life engagement, and emotional distress. The waitlist control group will be allowed to participate in the self-guided mindfulness intervention for emotional distress after completing the ten assessments.
Withdrawal criteria: failure to complete questionnaires for two consecutive times; failure to check in via the mini-program for seven consecutive days.
Participants
Sample size:
The intervention group will include five classes conducted simultaneously, with a maximum capacity of 250 participants.
The control group will include an equivalent number of 250 participants.
Measures:
Demographics, K10, PHQ-9, GAD-7, OASIS, ODSIS, FFMQ-SF, TTT, CFI, BEAQ, DTS, ELS, RNT (Repetitive Negative Thinking), CPSS-SF.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIED group | Experimental | The experimental group will participate in a self-guided mindfulness-based intervention for emotional distress, delivered via a WeChat Mini Program platform. The intervention requires daily completion of learning modules and practice exercises. Psychological assessments utilizing self-report questionnaires will be conducted at: baseline (pre-intervention), weekly during the intervention phase (weeks 2 through 7), immediately post-intervention, and at the 1-month follow-up. |
|
| Waitlist control group | No Intervention | Participants in the waitlist control group will be offered access to the self-guided mindfulness-based intervention after completing all ten assessments (same as the experimental group). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Intervention for Emotional Distress (self-guided version) | Behavioral | The self-guided version of the Mindfulness Intervention for Emotional Distress (MIED) is a WeChat mini-program that lasts 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). 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly changes of Overall Depression Severity and Impairment | 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. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly changes of Overall Anxiety Severity and Impairment | 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. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly 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. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly changes of Cognitive flexibility | 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. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly changes of Brief Experiential Avoidance | Chinese version of the Brief Experiential Avoidance Questionnaire is used to measure Experiential Avoidance.Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly 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. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Processing Sensitivity | The Chinese version of the Highly Sensitive Person Scale (HSPS) is a self-reported questionnaire designed to measure an individual's level of Sensory Processing Sensitivity (SPS). The scale consists of 27 items, with total scores ranging from 27 to 135. Higher scores indicate a higher level of sensory processing sensitivity, meaning the individual's traits are more inclined towards being a "highly sensitive person." |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mo Chen | Contact | +86 18950308693 | 514100919@qq.com | |
| Xinghua Liu | Contact | +86 13371669818 | xinghua_liu@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xinghua Liu | School of Psychological and Cognitive Sciences, Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University | Recruiting | Beijing | 100871 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly changes of Distress Tolerance | Distress Tolerance Scale is used to measure Distress Tolerance. Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly 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. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly 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. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly 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. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| 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. | before the intervention, during weeks 4 and 6 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly changes of Perseverative Thinking | Perseverative Thinking Questionnaire,16 items, scores range from 0 to 60, with higher scores indicating greater severity of repetitive negative thinking (RNT). | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| Weekly changes in perceived stress | The Chinese version of the Perceived Stress Scale - Short Form (CPSS-SF) is a 4-item self-report questionnaire assessing how unpredictable, uncontrollable, and overloaded individuals find their lives. Each item is rated on a 5-point scale from 0 (never) to 4 (very often). Total scores range from 0 to 16, with higher scores indicating greater perceived stress. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| weekly changes of Self-Compassion | The Self-Compassion Scale-Short Form is a self-reported questionnaire measuring the level of self-compassion. Scores range from 12 to 60, with higher scores indicating higher levels of self-compassion. | before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention |
| before the intervention |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided