Weekly Dynamics of Psychopathological and Symptom Networks During Mindfulness-Based Interventions for Emotional Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University
About this trial
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:
* How do the relationships between emotions, thoughts, and behaviors change week by week during mindfulness training? * Which psychological skills, such as distress tolerance or cognitive flexibility, improve first and lead to later emotional relief? Two groups will be compared - one that takes part in an online mindfulness intervention and one that waits to join - to see how the intervention changes emotional and psychological networks over time.
Participants will:
* Complete a 7-week online self-guided Mindfulness Intervention for Emotional Distress（iMIED） designed for people experiencing high emotional distress. * Fill out short weekly questionnaires about their emotions, thoughts, and behaviors before, during, and after the course (9 times in total). * Receive access to the mindfulness program after the study if they are in the wait-list group.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
experiencing emotional distress such as depression or anxiety (Kessler-10 score > 21)
Disqualifiers
prior experience with mindfulness meditation
current self-harm or suicidal risk
bipolar disorder or schizophrenia
history of substance abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Intervention for Emotional Distress (self-guided version)
BehavioralThe 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: MIED groupExperimental treatment 1 intervention
Group B: Waitlist control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention2
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.
Time frame
before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention3
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.
Time frame
before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention4
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.
Time frame
before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the interventionSecondary outcomes
1
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.
Time frame
before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention2
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.
Time frame
before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention3
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.
Time frame
before the intervention, weekly during weeks 2-7 of the intervention, immediately after the intervention, 1 month after the intervention4
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.
Time frame
before the intervention, during weeks 4 and 6 of the intervention, immediately after the intervention, 1 month after the interventionOther outcomes
1
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."
Time frame
before the interventionSponsors and contacts
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Source ClinicalTrials.gov