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/NCT06035003</url>
    </required_header>
    <id_info>
      <org_study_id>E20230905</org_study_id>
      <nct_id>NCT06035003</nct_id>
    </id_info>
    <brief_title>Mechanism of Mindfulness-Based Online Intervention in Reducing Emotional Distress</brief_title>
    <official_title>Mechanism of Mindfulness-Based Online Intervention in Reducing Emotional Distress</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>
        Traditional offline interventions such as MBCT and MBSR have been implemented to treat&#xD;
        patients with emotional disorders and obtained significantly improved clinical outcomes.&#xD;
        However, these offline interventions require the involvement of a therapist expert in&#xD;
        mindfulness and usually charge a high fee, which may not be accessible and cost-effective for&#xD;
        lots of patients with psychological disorders. Fortunately, online self-help interventions&#xD;
        can compensate for these disadvantages. Our research team has developed a self-help online&#xD;
        mindfulness program targeting emotional distress (i.e., MIED), which has been effective for&#xD;
        individuals with emotional distress in a preliminary study. Since patients with emotional&#xD;
        disorders usually suffer from emotional distress, the current study will apply this program&#xD;
        to these patients, and investigate its auxiliary effects on patients' psychological and&#xD;
        physical health.&#xD;
  &#xD;
        The primary aim of the current study is to evaluate the effectiveness of MIED for patients&#xD;
        with emotional disorders. To do so, we will use a design in which patients who receive online&#xD;
        mindfulness training (MIED) except for treatment as usual (TAU) will be compared with&#xD;
        patients who receive TAU alone. We expect the intervention to improve patients'&#xD;
        psychopathological symptoms reported by the patients and the clinicians or the research team&#xD;
        and increase their overall functioning, positive mental health, and physical health compared&#xD;
        to TAU. In addition, previous studies have shown that mindfulness interventions improve&#xD;
        psychological symptoms by improving cognitive flexibility, distress tolerance, intolerance of&#xD;
        uncertainty, and experiential avoidance. Therefore, the secondary aim of the study is to&#xD;
        examine the mediating effect of these factors on the relationships between mindfulness&#xD;
        practice and improvements in outcome variables.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</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 - Short Form during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]</time_frame>
      <description>The Five Facet Mindfulness Questionnaire - Short Form is a self-reported questionnaire measuring mindfulness levels. Scores range from 20 to 100, with higher scores indicating higher levels of mindfulness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Patient Health Questionnaire during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.&#xD;
  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>
    </primary_outcome>
    <primary_outcome>
      <measure>Weekly changes of Chinese Perceived Stress Scale during the intervention</measure>
      <time_frame>[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>[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>[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>[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 Athens Insomnia Scale during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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>
    </primary_outcome>
    <secondary_outcome>
      <measure>Weekly changes of Beck Anxiety Inventory during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Beck Anxiety Inventory is a self-reported questionnaire measuring anxiety. Scores range from 0 to 63, with higher scores indicating higher levels of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly changes of Beck Depression Inventory-II during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Beck Depression Inventory-II is a self-reported questionnaire measuring depression. Scores range from 0 to 63, with higher scores indicating higher levels of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly changes of Pittsburgh sleep quality Index during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Pittsburgh sleep quality Index is a self-reported questionnaire measuring sleep quality. Scores range from 0 to 21, with higher scores indicating lower levels of sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly changes of Insomnia Severity Index during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Insomnia Severity Index is a self-reported questionnaire measuring sleep quality. Scores range from 0 to 28, with higher scores indicating lower levels of sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly changes of Mindful Attention Awareness Scale during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Mindful Attention Awareness Scale is a self-reported questionnaire measuring mindfulness levels. Scores range from 15 to 90, with higher scores indicating higher levels of mindfulness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly changes of Quality of Relationship Index during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Quality of Relationship Index is a self-reported questionnaire measuring relationship quality. Scores range from 7 to 42, with higher scores indicating higher levels of relationship quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly changes of Interpersonal Reactivity Index-C during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Interpersonal Reactivity Index-C is a self-reported questionnaire measuring interpersonal reactivity. Scores range from 0 to 88, with higher scores indicating higher levels of interpersonal reactivity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly changes of Intimacy Check and Evaluation Scale during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Intimacy Check and Evaluation Scale is a self-reported questionnaire measuring relationship intimacy. Scores range from 5 to 105, with higher scores indicating higher levels of relationship intimacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Moderation effect and possible changes of the Experience Questionnaire during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Experience Questionnaire is a self-reported questionnaire measuring decentering ability. Scores range from 20 to 100, with higher scores indicating higher levels of decentering ability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Moderation effect and possible changes of the Emotion Regulation Questionnaire during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Experience Questionnaire is a self-reported questionnaire measuring emotion regulation ability. Scores range from 7 to 70, with higher scores indicating higher levels of emotion regulation ability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Moderation effect and possible changes of the Cognitive Flexibility Inventory during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Cognitive Flexibility Inventory is a self-reported questionnaire measuring cognitive flexibility level. Scores range from 5 to 100, with higher scores indicating higher levels of cognitive flexibility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Moderation effect and possible changes of the Treating Thoughts as Thoughts Scale during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Treating Thoughts as Thoughts Scale is a self-reported questionnaire measuring treating thoughts as thoughts ability. Scores range from 6 to 30, with higher scores indicating higher levels of treating thoughts as thoughts ability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Moderation effect and possible changes of the Scale of Life Engagement during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Scale of Life Engagement is a self-reported questionnaire measuring life engagement. Scores range from 0 to 56, with higher scores indicating higher levels of life engagement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Moderation effect and possible changes of the Self-Compassion Scale during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Self-Compassion Scale is a self-reported questionnaire measuring self- compassion. Scores range from 26 to 130, with higher scores indicating higher levels of self- compassion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Moderation effect and possible changes of the Rumination- Reflection Questionnaire during the intervention</measure>
      <time_frame>[Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]</time_frame>
      <description>The Rumination- Reflection Questionnaire is a self-reported questionnaire measuring rumination- reflection level. Scores range from 5 to 60, with higher scores indicating higher levels of rumination- reflection.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Emotional Distress</condition>
    <arm_group>
      <arm_group_label>MIED+TAU group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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>
    <arm_group>
      <arm_group_label>the TAU-only group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>treatment as usual (TAU) group consisted of all medicinal and psychological treatments received between baseline and follow-up (about five months). Medicinal treatments included receiving Lorazepam, Olanzapine, Paroxetine Hydrochloride, Sertraline, etc. Psychological treatments included receiving cognitive behavior therapy or psychodynamic therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness Intervention for Emotional Distress (MIED)</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>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>Amy Hu</last_name>
      <phone>18701585790</phone>
      <email>2101220069@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>
    <location>
      <facility>
        <name>Peking University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100871</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xinghua Liu</last_name>
        <phone>13371669818</phone>
        <email>xinghua_liu@pku.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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/NCT06035003
  org study id: E20230905
  nct id: NCT06035003
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Traditional offline interventions such as MBCT and MBSR have been implemented to treat
        patients with emotional disorders and obtained significantly improved clinical outcomes.
        However, these offline interventions require the involvement of a therapist expert in
        mindfulness and usually charge a high fee, which may not be accessible and cost-effective for
        lots of patients with psychological disorders. Fortunately, online self-help interventions
        can compensate for these disadvantages. Our research team has developed a self-help online
        mindfulness program targeting emotional distress (i.e., MIED), which has been effective for
        individuals with emotional distress in a preliminary study. Since patients with emotional
        disorders usually suffer from emotional distress, the current study will apply this program
        to these patients, and investigate its auxiliary effects on patients' psychological and
        physical health.
  
        The primary aim of the current study is to evaluate the effectiveness of MIED for patients
        with emotional disorders. To do so, we will use a design in which patients who receive online
        mindfulness training (MIED) except for treatment as usual (TAU) will be compared with
        patients who receive TAU alone. We expect the intervention to improve patients'
        psychopathological symptoms reported by the patients and the clinicians or the research team
        and increase their overall functioning, positive mental health, and physical health compared
        to TAU. In addition, previous studies have shown that mindfulness interventions improve
        psychological symptoms by improving cognitive flexibility, distress tolerance, intolerance of
        uncertainty, and experiential avoidance. Therefore, the secondary aim of the study is to
        examine the mediating effect of these factors on the relationships between mindfulness
        practice and improvements in outcome variables.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Weekly changes of Five Facet Mindfulness Questionnaire - Short Form during the intervention
  time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention]
  description: The Five Facet Mindfulness Questionnaire - Short Form is a self-reported questionnaire measuring mindfulness levels. Scores range from 20 to 100, with higher scores indicating higher levels of mindfulness.
  measure: Weekly changes of Patient Health Questionnaire during the intervention
  time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: Weekly changes of Chinese Perceived Stress Scale during the intervention
  time frame: [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: [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: [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: [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 Athens Insomnia Scale during the intervention
  time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: Weekly changes of Beck Anxiety Inventory during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Beck Anxiety Inventory is a self-reported questionnaire measuring anxiety. Scores range from 0 to 63, with higher scores indicating higher levels of anxiety.
  measure: Weekly changes of Beck Depression Inventory-II during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Beck Depression Inventory-II is a self-reported questionnaire measuring depression. Scores range from 0 to 63, with higher scores indicating higher levels of depression.
  measure: Weekly changes of Pittsburgh sleep quality Index during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Pittsburgh sleep quality Index is a self-reported questionnaire measuring sleep quality. Scores range from 0 to 21, with higher scores indicating lower levels of sleep quality.
  measure: Weekly changes of Insomnia Severity Index during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Insomnia Severity Index is a self-reported questionnaire measuring sleep quality. Scores range from 0 to 28, with higher scores indicating lower levels of sleep quality.
  measure: Weekly changes of Mindful Attention Awareness Scale during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Mindful Attention Awareness Scale is a self-reported questionnaire measuring mindfulness levels. Scores range from 15 to 90, with higher scores indicating higher levels of mindfulness.
  measure: Weekly changes of Quality of Relationship Index during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Quality of Relationship Index is a self-reported questionnaire measuring relationship quality. Scores range from 7 to 42, with higher scores indicating higher levels of relationship quality.
  measure: Weekly changes of Interpersonal Reactivity Index-C during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Interpersonal Reactivity Index-C is a self-reported questionnaire measuring interpersonal reactivity. Scores range from 0 to 88, with higher scores indicating higher levels of interpersonal reactivity.
  measure: Weekly changes of Intimacy Check and Evaluation Scale during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Intimacy Check and Evaluation Scale is a self-reported questionnaire measuring relationship intimacy. Scores range from 5 to 105, with higher scores indicating higher levels of relationship intimacy.
  measure: Moderation effect and possible changes of the Experience Questionnaire during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Experience Questionnaire is a self-reported questionnaire measuring decentering ability. Scores range from 20 to 100, with higher scores indicating higher levels of decentering ability.
  measure: Moderation effect and possible changes of the Emotion Regulation Questionnaire during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Experience Questionnaire is a self-reported questionnaire measuring emotion regulation ability. Scores range from 7 to 70, with higher scores indicating higher levels of emotion regulation ability.
  measure: Moderation effect and possible changes of the Cognitive Flexibility Inventory during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Cognitive Flexibility Inventory is a self-reported questionnaire measuring cognitive flexibility level. Scores range from 5 to 100, with higher scores indicating higher levels of cognitive flexibility.
  measure: Moderation effect and possible changes of the Treating Thoughts as Thoughts Scale during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Treating Thoughts as Thoughts Scale is a self-reported questionnaire measuring treating thoughts as thoughts ability. Scores range from 6 to 30, with higher scores indicating higher levels of treating thoughts as thoughts ability.
  measure: Moderation effect and possible changes of the Scale of Life Engagement during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Scale of Life Engagement is a self-reported questionnaire measuring life engagement. Scores range from 0 to 56, with higher scores indicating higher levels of life engagement.
  measure: Moderation effect and possible changes of the Self-Compassion Scale during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Self-Compassion Scale is a self-reported questionnaire measuring self- compassion. Scores range from 26 to 130, with higher scores indicating higher levels of self- compassion.
  measure: Moderation effect and possible changes of the Rumination- Reflection Questionnaire during the intervention
  time frame: [Time Frame: pre-intervention; after the 3rd week intervention; after the 5th week intervention; after the 7-week intervention]
  description: The Rumination- Reflection Questionnaire is a self-reported questionnaire measuring rumination- reflection level. Scores range from 5 to 60, with higher scores indicating higher levels of rumination- reflection.
  arm group label: MIED+TAU group
  arm group type: Experimental
  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 TAU-only group
  arm group type: No Intervention
  description: treatment as usual (TAU) group consisted of all medicinal and psychological treatments received between baseline and follow-up (about five months). Medicinal treatments included receiving Lorazepam, Olanzapine, Paroxetine Hydrochloride, Sertraline, etc. Psychological treatments included receiving cognitive behavior therapy or psychodynamic therapy.
  intervention type: Behavioral
  intervention name: Mindfulness Intervention for Emotional Distress (MIED)
  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: 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: Amy Hu
  phone: 18701585790
  email: 2101220069@stu.pku.edu.cn
  last name: Xinghua Liu
  phone: 13371669818
  email: xinghua_liu@pku.edu.cn
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No