xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06034613</url>
    </required_header>
    <id_info>
      <org_study_id>E20230830</org_study_id>
      <nct_id>NCT06034613</nct_id>
    </id_info>
    <brief_title>The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: Daily Interventions and Daily Assessments</brief_title>
    <official_title>The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: Daily Interventions and Daily Assessments</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial seeks to uncover the mechanisms behind the effectiveness of&#xD;
        mindfulness-based interventions in reducing emotional distress. Using daily diaries to&#xD;
        measure both mediating and outcome variables, the study examines whether these mechanisms&#xD;
        precede changes in outcomes. It focuses on the Mindfulness Intervention for Emotional&#xD;
        Distress program, which includes four strategies. The current study plans to employ a&#xD;
        within-subjects design with daily questionnaires over 63 days, before, during and after the&#xD;
        intervention. The aim is to gain insights into how mindfulness interventions work in&#xD;
        alleviating emotional distress.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        An abundance of research studies has demonstrated the potential efficacy of mindfulness-based&#xD;
        interventions in alleviating emotional distress among individuals. However, the underlying&#xD;
        mechanisms driving these effects have remained largely unknown. Furthermore, many of the&#xD;
        mechanistic investigations have not taken into account the temporal precedence, where changes&#xD;
        in mechanisms occur prior to changes in outcome variables.&#xD;
  &#xD;
        To address these gaps, this clinical trial aims to enhance our understanding of the&#xD;
        mechanisms behind mindfulness-based interventions for emotional distress. By employing a&#xD;
        daily diary approach to measure both mediating and outcome variables, investigators seek to&#xD;
        rigorously examine whether the proposed mediating variables adhere to the criterion of&#xD;
        temporal precedence. Additionally, utilizing daily diaries allows for the collection of&#xD;
        extensive individual-level data. This approach also permits a network analysis perspective to&#xD;
        explore the roles of various mechanistic variables in the context of mitigating emotional&#xD;
        distress.&#xD;
  &#xD;
        The present study focuses on the Mindfulness Intervention for Emotional Distress program&#xD;
        (liu, in press), comprising four key strategies: 1) Engaging in life to restore a sense of&#xD;
        normalcy; 2) Enhancing distress tolerance; 3) Reducing excessive emotional reactivity; 4)&#xD;
        Cultivating cognitive flexibility by treating thoughts as mere mental events. Through the&#xD;
        implementation of daily diaries, investigators aim to uncover the mechanistic workings of&#xD;
        these four strategies.&#xD;
  &#xD;
        The current study plans to employ a within-subjects design, with participants all receiving&#xD;
        mindfulness intervention. They are required to complete daily measurement questionnaires&#xD;
        during the week prior to intervention, throughout the intervention period, and for a week&#xD;
        following the intervention. The measurement period spans a total of 63 days.&#xD;
  &#xD;
        Through this study design, investigators aim to gain valuable insights into the mechanisms&#xD;
        underpinning the effectiveness of mindfulness interventions in alleviating emotional&#xD;
        distress.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Daily changes of mindfulness</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>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).&#xD;
  scores range from 4 to 40, with higher scores indicating higher levels of mindful responding</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily changes of engaging in everyday life</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>Self-developed questionnaire, measuring to what extent individuals put efforts and time in engaging in everyday life (e.g., work, social, leisure...), 6 items, scores range from 6 to 54, with higher scores indicating higher levels of engaging in everyday life</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily changes of distress tolerance</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>measured by Daily distress tolerance scale, four items, scores range from 4 to 20, with higher scores indicating higher levels of distress tolerance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily changes of excessive emotion behaviors</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>self-developed scale, measuring to what extent individuals use excessive emotion behaviors to control aversive feelings and emotions, 4 items, scores range from 4 to 20, with higher scores indicating higher levels of using excessive emotion behaviors.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily changes of cognitive flexibility/treating thoughts as thoughts</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>self-developed questionnaire, measuring to what extent individuals could treat thoughts as psychological phenomenon rather than facts, 4 items, scores range from 4 to 20, with higher scores indicating higher levels of cognitive flexibility.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>daily changes of anxiety</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>daily changes of depression</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily changes of positive and negative affect</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>daily stress</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>Daily perceived stress was assessed with the previously validated four-item version of the Perceived Stress Scale, The PSS measures the degree to which situations in one's life are evaluated as stressful (e.g., &quot;Today, to what extent did you feel confident about your ability to handle your personal problems?&quot;). Participants rated the accuracy of the items using a scale ranging from 1 (very little)to 10 (very much). scores range from 4 to 40.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>daily stressors</measure>
      <time_frame>once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)</time_frame>
      <description>Daily stressor exposure was measured with 1 item, 0 = no, 1 = yes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of Five Facet Mindfulness Questionnaire</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of Chinese Perceived Stress Scale</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>The Chinese Perceived Stress Scale is a self-reported questionnaire measuring stress. Scores range from 0 to 56, with higher scores indicating higher levels of stress</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of 10-item Kessler Psychological Distress Scale</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of the Overall Anxiety Severity and Impairment Scale</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of the Overall Depression Severity and Impairment Scale</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of Patient Health Questionnaire during the intervention</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>The Patient Health Questionnaire is a self-reported questionnaire measuring the degree of being troubled by various common physical symptoms. Scores range from 0 to 30.0~4 scores: no physical symptoms; 5~9 scores: mild physical symptoms; 10~14 scores: moderate physical symptoms; 15~30 scores: severe physical symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of Distress Tolerance Scale</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>Distress Tolerance Scale is used to measure Distress Tolerance. Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of Beck Anxiety Inventory</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>Beck Anxiety Inventory is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, with higher scores indicating higher levels of Anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of Beck Depression Inventory</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>Beck Depression Inventory is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, with higher scores indicating higher levels of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of Athens Insomnia Scale</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of engaging in everyday life</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>The Chinese version of the Likert 5-point self-administered scale contains five dimensions, including sleep, diet, socialization, work and study, and other aspects, with a total of 15 entries, and the higher the total score indicates the worse the state of life compared with the surrounding people. The internal consistency reliability of the scale was 0.895, and the results of factor analysis and convergent validity analysis were good.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of treating thoughts as thoughts/cognitive flexibility</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>The questionnaire has 1 dimension and contains 6 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of the Brief Experiential Avoidance Questionnaire</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pre-post changes of the Rumination sub-scale</measure>
      <time_frame>1 week before the intervention, 1week after the intervention</time_frame>
      <description>12 items from the Rumination-Reflection Questionnaire, the Rumination subscale. Total scores range from 5 to 60, with higher scores indicating higher levels of rumination.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Emotional Distress</condition>
    <arm_group>
      <arm_group_label>mindfulness intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>internet-based mindfulness intervention for emotional distress(iMIED）</intervention_name>
      <description>The iMIED program integrates the rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth brushing) were adapted from MBIs. In addition, the iMIED program selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks. In total, it took about 30 min per day to finish all the tasks. The program lasted for 49 days.</description>
      <arm_group_label>mindfulness intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects who could not access the Internet.&#xD;
  &#xD;
            -  Subjects with insufficient Chinese ability.&#xD;
  &#xD;
            -  Subjects who have participated in mindfulness-based projects for more than 6 weeks&#xD;
               before, and / or the current frequency of meditation practice is more than once a&#xD;
               week.&#xD;
  &#xD;
            -  Patients with schizophrenia or psychotic affective disorder, current organic mental&#xD;
               disorder, substance abuse disorder and generalized developmental disorder.&#xD;
  &#xD;
            -  Subjects at risk of suicide.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xinghua Liu</last_name>
      <role>Principal Investigator</role>
      <affiliation>School of Psychological and Cognitive Sciences, Peking University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yanjuan Li</last_name>
      <phone>+8615992425499</phone>
      <email>Lyjanice@stu.pku.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xinghua Liu</last_name>
      <phone>13371669818</phone>
      <email>xinghua_liu@pku.edu.cn</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University</investigator_affiliation>
      <investigator_full_name>Xinghua Liu</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06034613
  org study id: E20230830
  nct id: NCT06034613
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial seeks to uncover the mechanisms behind the effectiveness of
        mindfulness-based interventions in reducing emotional distress. Using daily diaries to
        measure both mediating and outcome variables, the study examines whether these mechanisms
        precede changes in outcomes. It focuses on the Mindfulness Intervention for Emotional
        Distress program, which includes four strategies. The current study plans to employ a
        within-subjects design with daily questionnaires over 63 days, before, during and after the
        intervention. The aim is to gain insights into how mindfulness interventions work in
        alleviating emotional distress.
  An abundance of research studies has demonstrated the potential efficacy of mindfulness-based
        interventions in alleviating emotional distress among individuals. However, the underlying
        mechanisms driving these effects have remained largely unknown. Furthermore, many of the
        mechanistic investigations have not taken into account the temporal precedence, where changes
        in mechanisms occur prior to changes in outcome variables.
  
        To address these gaps, this clinical trial aims to enhance our understanding of the
        mechanisms behind mindfulness-based interventions for emotional distress. By employing a
        daily diary approach to measure both mediating and outcome variables, investigators seek to
        rigorously examine whether the proposed mediating variables adhere to the criterion of
        temporal precedence. Additionally, utilizing daily diaries allows for the collection of
        extensive individual-level data. This approach also permits a network analysis perspective to
        explore the roles of various mechanistic variables in the context of mitigating emotional
        distress.
  
        The present study focuses on the Mindfulness Intervention for Emotional Distress program
        (liu, in press), comprising four key strategies: 1) Engaging in life to restore a sense of
        normalcy; 2) Enhancing distress tolerance; 3) Reducing excessive emotional reactivity; 4)
        Cultivating cognitive flexibility by treating thoughts as mere mental events. Through the
        implementation of daily diaries, investigators aim to uncover the mechanistic workings of
        these four strategies.
  
        The current study plans to employ a within-subjects design, with participants all receiving
        mindfulness intervention. They are required to complete daily measurement questionnaires
        during the week prior to intervention, throughout the intervention period, and for a week
        following the intervention. The measurement period spans a total of 63 days.
  
        Through this study design, investigators aim to gain valuable insights into the mechanisms
        underpinning the effectiveness of mindfulness interventions in alleviating emotional
        distress.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  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)
  description: 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
  measure: 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)
  description: Self-developed questionnaire, measuring to what extent individuals put efforts and time in engaging in everyday life (e.g., work, social, leisure...), 6 items, scores range from 6 to 54, with higher scores indicating higher levels of engaging in everyday life
  measure: 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)
  description: measured by Daily distress tolerance scale, four items, scores range from 4 to 20, with higher scores indicating higher levels of distress tolerance.
  measure: Daily changes of excessive emotion behaviors
  time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
  description: self-developed scale, measuring to what extent individuals use excessive emotion behaviors to control aversive feelings and emotions, 4 items, scores range from 4 to 20, with higher scores indicating higher levels of using excessive emotion behaviors.
  measure: Daily changes of cognitive flexibility/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)
  description: self-developed questionnaire, measuring to what extent individuals could treat thoughts as psychological phenomenon rather than facts, 4 items, scores range from 4 to 20, with higher scores indicating higher levels of cognitive flexibility.
  measure: 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)
  description: Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.
  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)
  description: Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.
  measure: 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)
  description: 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.
  measure: daily stress
  time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
  description: Daily perceived stress was assessed with the previously validated four-item version of the Perceived Stress Scale, The PSS measures the degree to which situations in one's life are evaluated as stressful (e.g., "Today, to what extent did you feel confident about your ability to handle your personal problems?"). Participants rated the accuracy of the items using a scale ranging from 1 (very little)to 10 (very much). scores range from 4 to 40.
  measure: daily stressors
  time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
  description: Daily stressor exposure was measured with 1 item, 0 = no, 1 = yes
  measure: pre-post changes of Five Facet Mindfulness Questionnaire
  time frame: 1 week before the intervention, 1week after the intervention
  description: 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.
  measure: pre-post changes of Chinese Perceived Stress Scale
  time frame: 1 week before the intervention, 1week after the intervention
  description: The Chinese Perceived Stress Scale is a self-reported questionnaire measuring stress. Scores range from 0 to 56, with higher scores indicating higher levels of stress
  measure: pre-post changes of 10-item Kessler Psychological Distress Scale
  time frame: 1 week before the intervention, 1week after the intervention
  description: 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.
  measure: pre-post changes of the Overall Anxiety Severity and Impairment Scale
  time frame: 1 week before the intervention, 1week after the intervention
  description: 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.
  measure: pre-post changes of the Overall Depression Severity and Impairment Scale
  time frame: 1 week before the intervention, 1week after the intervention
  description: 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.
  measure: pre-post changes of Patient Health Questionnaire during the intervention
  time frame: 1 week before the intervention, 1week after the intervention
  description: The Patient Health Questionnaire is a self-reported questionnaire measuring the degree of being troubled by various common physical symptoms. Scores range from 0 to 30.0~4 scores: no physical symptoms; 5~9 scores: mild physical symptoms; 10~14 scores: moderate physical symptoms; 15~30 scores: severe physical symptoms.
  measure: pre-post changes of Distress Tolerance Scale
  time frame: 1 week before the intervention, 1week after the intervention
  description: Distress Tolerance Scale is used to measure Distress Tolerance. Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance.
  measure: pre-post changes of Beck Anxiety Inventory
  time frame: 1 week before the intervention, 1week after the intervention
  description: Beck Anxiety Inventory is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, with higher scores indicating higher levels of Anxiety.
  measure: pre-post changes of Beck Depression Inventory
  time frame: 1 week before the intervention, 1week after the intervention
  description: Beck Depression Inventory is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, with higher scores indicating higher levels of depression.
  measure: pre-post changes of Athens Insomnia Scale
  time frame: 1 week before the intervention, 1week after the intervention
  description: 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.
  measure: pre-post changes of engaging in everyday life
  time frame: 1 week before the intervention, 1week after the intervention
  description: The Chinese version of the Likert 5-point self-administered scale contains five dimensions, including sleep, diet, socialization, work and study, and other aspects, with a total of 15 entries, and the higher the total score indicates the worse the state of life compared with the surrounding people. The internal consistency reliability of the scale was 0.895, and the results of factor analysis and convergent validity analysis were good.
  measure: pre-post changes of treating thoughts as thoughts/cognitive flexibility
  time frame: 1 week before the intervention, 1week after the intervention
  description: The questionnaire has 1 dimension and contains 6 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.
  measure: pre-post changes of the Brief Experiential Avoidance Questionnaire
  time frame: 1 week before the intervention, 1week after the intervention
  description: 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.
  measure: pre-post changes of the Rumination sub-scale
  time frame: 1 week before the intervention, 1week after the intervention
  description: 12 items from the Rumination-Reflection Questionnaire, the Rumination subscale. Total scores range from 5 to 60, with higher scores indicating higher levels of rumination.
  arm group label: mindfulness intervention group
  arm group type: Experimental
  description: 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.
  intervention type: Behavioral
  intervention name: internet-based mindfulness intervention for emotional distress(iMIED）
  description: The iMIED program integrates the rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth brushing) were adapted from MBIs. In addition, the iMIED program selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks. In total, it took about 30 min per day to finish all the tasks. The program lasted for 49 days.
  arm group label: mindfulness intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xinghua Liu
  role: Principal Investigator
  affiliation: School of Psychological and Cognitive Sciences, Peking University
  last name: Yanjuan Li
  phone: +8615992425499
  email: Lyjanice@stu.pku.edu.cn
  last name: Xinghua Liu
  phone: 13371669818
  email: xinghua_liu@pku.edu.cn
  responsible party type: Principal Investigator
  investigator affiliation: Peking University
  investigator full name: Xinghua Liu
  investigator title: Director
  sharing ipd: No