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/NCT05981248</url>
    </required_header>
    <id_info>
      <org_study_id>E20230815</org_study_id>
      <nct_id>NCT05981248</nct_id>
    </id_info>
    <brief_title>Experiential Avoidance as the Mechanism of Mindfulness Intervention in Reducing Emotional Distress: Daily Dairy Research</brief_title>
    <official_title>Experiential Avoidance as the Mechanism of Mindfulness Based Intervention in Reducing Emotional Distress: Daily Dairy Research</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 study hopes to:&#xD;
  &#xD;
          1. explore whether three weeks of MIED could promote experiential avoidance.&#xD;
  &#xD;
          2. explore experiential avoidance could be a mediation of outcomes of MIED.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Experiential avoidance refers to individuals resisting experiences or trying to eliminate&#xD;
        certain experiences (such as emotions, thoughts, physical feelings, memory and behavioral&#xD;
        tendencies, etc.), and trying to adopt corresponding strategies to change these experiences&#xD;
        and the situations in which the experiences are generated (Hayes, Wilson, Gifford, Follette,&#xD;
        &amp; Strosahl, 1996). Experiential avoidance has been proved to be a maintenance factor for many&#xD;
        psychological disorders (Boelen &amp; Reijntjes, 2008), and trying to hide or suppress unpleasant&#xD;
        thoughts, feelings and physical feelings will increase the frequency and pain of these same&#xD;
        experiences (Gross,1998; Gross,2002; Sloan, 2004; Wegner, 1994). According to some reviews,&#xD;
        experiential avoidance is one of the beneficial effects of mindfulness (Brown, Bravo, Roos, &amp;&#xD;
        Pearson, 2015; Shapiro et al., 2006). However, no study has examined experiential avoidance&#xD;
        as mediator in mindfulness intervention whether in the between-subject or in within-subject&#xD;
        level . Therefore, this study uses daily diary research explore the role of experiential&#xD;
        avoidance as the effective mechanism of mindfulness intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Weekly changes of Five Facet Mindfulness Questionnaire during the intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week 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>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Chinese Perceived Stress Scale during the intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week 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>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week 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>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week 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>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Overall Depression Severity and Impairment Scale during the intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week 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>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Inner Peace Scale during the intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week intervention</time_frame>
      <description>The Inner Peace Scale is a self-reported questionnaire measuring peace. Scores range from 0 to 28, with higher scores indicating higher levels of peace.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Depression-Anxiety-Stress Scale during the intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week intervention</time_frame>
      <description>The Depression-Anxiety-Stress Scale is a self-reported questionnaire measuring psychological health. Scores range from 0 to 63, with higher scores indicating higher levels of depression, anxiety or stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Acceptance and Action Questionnaire-II during the intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week intervention</time_frame>
      <description>The Acceptance and Action Questionnaire-II is a self-reported questionnaire measuring experiential avoidance. Scores range from 7 to 49, with higher scores indicating higher levels of experiential avoidance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Brief Experiential Avoidance Questionnaire during the I intervention</measure>
      <time_frame>pre-intervention; weekly during the 7-week intervention; after the 7-week intervention</time_frame>
      <description>The Brief Experiential Avoidance Questionnaire is a self-reported questionnaire measuring experiential avoidance. Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily changes of experiential avoidance</measure>
      <time_frame>once a day in the first three weeks of the intervention</time_frame>
      <description>There are 7 items, 4 of which evaluate the use of specific experiential avoidance strategies today, including distraction , redundant thinking, thought suppression and reassessment and 3 of which evaluate today's broader experiential avoidance. Scores range from 7 to 35, with higher scores indicating higher levels of experiential avoidance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily changes of anxiety</measure>
      <time_frame>once a day in the first three weeks of the intervention</time_frame>
      <description>Daily anxiety was assessed using a 6-item shortened version of the State-Trait Anxiety Inventory. Scores range from 6 to 24, with higher scores indicating higher levels of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily changes of depression</measure>
      <time_frame>once a day in the first three weeks of the intervention</time_frame>
      <description>Daily depressive symptoms were measured by a 10-item modified version of the Centre for Epidemiologic Studies Depressive Scale with item wordings adapted to include the word 'today' and the instructions modified. Scores range from 0 to 30, 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 a day in the first three weeks of the 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 stressor exposure</measure>
      <time_frame>once a day in the first three weeks of the intervention</time_frame>
      <description>Daily stressor exposure was measured using a 7-item scale from the Daily Inventory of Stressful Events. if at least one stressor event was experienced by the participant within the day, it was then categorized as a stressor day. If no stressor events were experienced on the day, it was categorized as a non-stressor day.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily mindfulness</measure>
      <time_frame>once a day in the first three weeks of the intervention</time_frame>
      <description>5 items with the highest factor from each subscale of the Five-Facet Mindfulness Questionnaire were chosen. Scores range from 5 to 25, with higher scores indicating higher levels of mindfulness.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Emotional Distress</condition>
    <arm_group>
      <arm_group_label>the MIED+TAU 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>
    <arm_group>
      <arm_group_label>the TAU-only group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>treated as usual</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness Intervention for Emotional Distress</intervention_name>
      <description>Mindfulness Intervention for Emotional Distress (MIED) program 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_label>the MIED+TAU 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>No</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>Mengyao He</last_name>
      <phone>+86 18811317929</phone>
      <email>1901110649@pku.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xinghua Liu</last_name>
      <phone>+86 13371669818</phone>
      <email>xinghua_liu@pku.edu.cn</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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/NCT05981248
  org study id: E20230815
  nct id: NCT05981248
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study hopes to:
  
          1. explore whether three weeks of MIED could promote experiential avoidance.
  
          2. explore experiential avoidance could be a mediation of outcomes of MIED.
  Experiential avoidance refers to individuals resisting experiences or trying to eliminate
        certain experiences (such as emotions, thoughts, physical feelings, memory and behavioral
        tendencies, etc.), and trying to adopt corresponding strategies to change these experiences
        and the situations in which the experiences are generated (Hayes, Wilson, Gifford, Follette,
        & Strosahl, 1996). Experiential avoidance has been proved to be a maintenance factor for many
        psychological disorders (Boelen & Reijntjes, 2008), and trying to hide or suppress unpleasant
        thoughts, feelings and physical feelings will increase the frequency and pain of these same
        experiences (Gross,1998; Gross,2002; Sloan, 2004; Wegner, 1994). According to some reviews,
        experiential avoidance is one of the beneficial effects of mindfulness (Brown, Bravo, Roos, &
        Pearson, 2015; Shapiro et al., 2006). However, no study has examined experiential avoidance
        as mediator in mindfulness intervention whether in the between-subject or in within-subject
        level . Therefore, this study uses daily diary research explore the role of experiential
        avoidance as the effective mechanism of mindfulness intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Weekly changes of Five Facet Mindfulness Questionnaire during the intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: Weekly changes of Chinese Perceived Stress Scale during the intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: Weekly changes of Overall Depression Severity and Impairment Scale during the intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: Weekly changes of Inner Peace Scale during the intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
  description: The Inner Peace Scale is a self-reported questionnaire measuring peace. Scores range from 0 to 28, with higher scores indicating higher levels of peace.
  measure: Weekly changes of Depression-Anxiety-Stress Scale during the intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
  description: The Depression-Anxiety-Stress Scale is a self-reported questionnaire measuring psychological health. Scores range from 0 to 63, with higher scores indicating higher levels of depression, anxiety or stress.
  measure: Weekly changes of Acceptance and Action Questionnaire-II during the intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
  description: The Acceptance and Action Questionnaire-II is a self-reported questionnaire measuring experiential avoidance. Scores range from 7 to 49, with higher scores indicating higher levels of experiential avoidance.
  measure: Weekly changes of Brief Experiential Avoidance Questionnaire during the I intervention
  time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
  description: The Brief Experiential Avoidance Questionnaire is a self-reported questionnaire measuring experiential avoidance. Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.
  measure: Daily changes of experiential avoidance
  time frame: once a day in the first three weeks of the intervention
  description: There are 7 items, 4 of which evaluate the use of specific experiential avoidance strategies today, including distraction , redundant thinking, thought suppression and reassessment and 3 of which evaluate today's broader experiential avoidance. Scores range from 7 to 35, with higher scores indicating higher levels of experiential avoidance.
  measure: Daily changes of anxiety
  time frame: once a day in the first three weeks of the intervention
  description: Daily anxiety was assessed using a 6-item shortened version of the State-Trait Anxiety Inventory. Scores range from 6 to 24, with higher scores indicating higher levels of anxiety.
  measure: Daily changes of depression
  time frame: once a day in the first three weeks of the intervention
  description: Daily depressive symptoms were measured by a 10-item modified version of the Centre for Epidemiologic Studies Depressive Scale with item wordings adapted to include the word 'today' and the instructions modified. Scores range from 0 to 30, with higher scores indicating higher levels of depression.
  measure: Daily changes of positive and negative affect
  time frame: once a day in the first three weeks of the 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 stressor exposure
  time frame: once a day in the first three weeks of the intervention
  description: Daily stressor exposure was measured using a 7-item scale from the Daily Inventory of Stressful Events. if at least one stressor event was experienced by the participant within the day, it was then categorized as a stressor day. If no stressor events were experienced on the day, it was categorized as a non-stressor day.
  measure: Daily mindfulness
  time frame: once a day in the first three weeks of the intervention
  description: 5 items with the highest factor from each subscale of the Five-Facet Mindfulness Questionnaire were chosen. Scores range from 5 to 25, with higher scores indicating higher levels of mindfulness.
  arm group label: the MIED+TAU 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.
  arm group label: the TAU-only group
  arm group type: No Intervention
  description: treated as usual
  intervention type: Behavioral
  intervention name: Mindfulness Intervention for Emotional Distress
  description: Mindfulness Intervention for Emotional Distress (MIED) program 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.
  arm group label: the MIED+TAU group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Xinghua Liu
  role: Principal Investigator
  affiliation: School of Psychological and Cognitive Sciences, Peking University
  last name: Mengyao He
  phone: +86 18811317929
  email: 1901110649@pku.edu.cn
  last name: Xinghua Liu
  phone: +86 13371669818
  email: xinghua_liu@pku.edu.cn
  responsible party type: Sponsor
  sharing ipd: No