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/NCT06014281</url>
    </required_header>
    <id_info>
      <org_study_id>68784</org_study_id>
      <nct_id>NCT06014281</nct_id>
    </id_info>
    <brief_title>Examining the Effects of Regular Brief Internet-based Meditation Practice on Mental Health and Well Being</brief_title>
    <official_title>An Internet-administered Randomized Control Trial to Examine the Effects of Regular, Brief Meditation Practice on Mental Health and Well Being</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institute for Meditation and Inner Harmony</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Feldman Foundation CA</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will examine the effects of online meditation training on stress and anxiety in&#xD;
        healthy participants. It will also examine the dose-response relationship between the amount&#xD;
        of daily focused attention meditation practice and established mental health outcome&#xD;
        measures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a 16-week study with an 8-week meditation intervention, with a requirement of a&#xD;
        minimum of 10 minutes of meditation practice each day. This study will recruit ~200 healthy&#xD;
        subjects (18+ years) with no current or previous diagnosis of psychiatric or neurological&#xD;
        disorders who are interested in learning about meditation but don't have long-term experience&#xD;
        with meditation. Half of the participant pool will be randomly assigned to the meditation&#xD;
        intervention, and the other half will get the wait-list control assignment. The control group&#xD;
        will later receive its intervention, likely a few weeks after the completion of the active&#xD;
        group's intervention. A focused-attention meditation technique (SOS meditation) will be used&#xD;
        to train participants.&#xD;
  &#xD;
        Changes in participants' physiological markers (e.g., HRV, physical activity, respiration&#xD;
        rate, sleep quality) will be evaluated using passive activity monitoring devices (e.g.,&#xD;
        Fitbit). Intervention-related changes in mental health will be assessed using web-based&#xD;
        mental health and well-being surveys. Improvements in cognitive functioning will be assessed&#xD;
        using web-based psychological tasks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>Change in Generalize Anxiety Disorder Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Anxiety as measured using Generalize Anxiety Disorder Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Pittsburgh Sleep Quality Index Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Sleep Quality measured using Pittsburgh sleep quality index (PSQI)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Mind Wandering Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Mind wandering measured using the Mind Wandering Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Resting Heart Rate</measure>
      <time_frame>Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)</time_frame>
      <description>Daily obtained from Activity Tracker wrist band</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart Rate Variability</measure>
      <time_frame>Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)</time_frame>
      <description>Daily obtained from Activity Tracker wrist band</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Stroop Test Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Using the Stroop test, which measures the average reaction time between incongruent and congruent trials</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in N-back Test Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Using the N-back test is a memory task where participants must remember letters from N trials ago.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Stress Scale Measure Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Stress measured using Perceived Stress Scale measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Depression Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Depression measured using Patient Health Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of Life Scale Measures Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Quality of life measured using Quality of Life Scale measures</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change Social Connectedness Scale-Revised Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Social Connectedness measured using Social Connectedness Scale-Revised</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Rumination Reflection Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Rumination and reflection scales measured using Rumination Reflection Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Brief Strengths Scale Questionnaire Score</measure>
      <time_frame>Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)</time_frame>
      <description>Strengths scale measured using Brief Strengths Scale measures individuals' Temperance Strength, Intellectual Strength, and Interpersonal Strength.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Sleep Quality Measure</measure>
      <time_frame>Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)</time_frame>
      <description>Daily obtained from Activity Tracker wrist band</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Healthy</condition>
    <condition>Well-Being, Psychological</condition>
    <arm_group>
      <arm_group_label>Meditation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Baseline to week 8:&#xD;
  Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed.&#xD;
  Week 8 to week 16:&#xD;
  Subjects will self report if they choose to continue SOS meditation and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the impact of continued meditation practice on mental health and well being.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Baseline to week 8:&#xD;
  Subjects will be place in a control group which receives no intervention. However, several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess baseline mental health and well being scores.&#xD;
  Week 8 to week 16:&#xD;
  Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SOS Meditation</intervention_name>
      <description>Focused-attention meditation technique will be used to train participants, specifically the SOS meditation technique. The SOS meditation technique is an easy-to-learn approach where participants are instructed to dissociate their attention from physical awareness, thoughts, and emotions by mentally slowly repeating a calming word or phrase (chosen by the participant themselves).&#xD;
  SOS Meditation Instructions:&#xD;
  Close your eyes very gently, in a relaxed way, as you do when we go to sleep&#xD;
  Your attention should be fully alert. Try not to put any strain on your eyes or try to look up.&#xD;
  Focus your eyes about eight to ten inches into the field of darkness in front of you on the horizontal plane&#xD;
  Mentally repeat the (chosen) calming word&#xD;
  Sit lovingly and calmly to see what comes up, as if you were watching a movie screen and waiting to see what appears on it.</description>
      <arm_group_label>Meditation group</arm_group_label>
      <arm_group_label>Waitlist control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Able to follow basic instructions for prescreening and scheduling&#xD;
  &#xD;
            -  Compliant with investigator instructions during the consent process and participation&#xD;
               in the study&#xD;
  &#xD;
            -  Is not already a regular meditation practitioner&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18&#xD;
  &#xD;
            -  People with a current diagnosis of psychiatric or neurological disorders&#xD;
  &#xD;
            -  Be in current psychiatric treatment or medications&#xD;
  &#xD;
            -  Hospitalized for psychiatric disorders in the past year or so.&#xD;
  &#xD;
            -  Regular and long-term meditation practitioners&#xD;
  &#xD;
            -  Non-English speaking&#xD;
  &#xD;
            -  Non-USA mailing address to receive the activity tracker device&#xD;
  &#xD;
            -  Vision or hearing impairment severe enough to interfere with study participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Manish Saggar, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Dept. of Psychiatry, Stanford University</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Manish Saggar, PhD</last_name>
        <phone>650-723-3656</phone>
        <email>braindynamicslab@stanford.edu</email>
      </contact>
      <investigator>
        <last_name>Manish Saggar, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>David Spiegel, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Manish Saggar</investigator_full_name>
      <investigator_title>Assistant Professor</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/NCT06014281
  org study id: 68784
  nct id: NCT06014281
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study will examine the effects of online meditation training on stress and anxiety in
        healthy participants. It will also examine the dose-response relationship between the amount
        of daily focused attention meditation practice and established mental health outcome
        measures.
  This is a 16-week study with an 8-week meditation intervention, with a requirement of a
        minimum of 10 minutes of meditation practice each day. This study will recruit ~200 healthy
        subjects (18+ years) with no current or previous diagnosis of psychiatric or neurological
        disorders who are interested in learning about meditation but don't have long-term experience
        with meditation. Half of the participant pool will be randomly assigned to the meditation
        intervention, and the other half will get the wait-list control assignment. The control group
        will later receive its intervention, likely a few weeks after the completion of the active
        group's intervention. A focused-attention meditation technique (SOS meditation) will be used
        to train participants.
  
        Changes in participants' physiological markers (e.g., HRV, physical activity, respiration
        rate, sleep quality) will be evaluated using passive activity monitoring devices (e.g.,
        Fitbit). Intervention-related changes in mental health will be assessed using web-based
        mental health and well-being surveys. Improvements in cognitive functioning will be assessed
        using web-based psychological tasks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Generalize Anxiety Disorder Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Anxiety as measured using Generalize Anxiety Disorder Questionnaire
  measure: Change in Pittsburgh Sleep Quality Index Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Sleep Quality measured using Pittsburgh sleep quality index (PSQI)
  measure: Change in Mind Wandering Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Mind wandering measured using the Mind Wandering Questionnaire
  measure: Resting Heart Rate
  time frame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
  description: Daily obtained from Activity Tracker wrist band
  measure: Heart Rate Variability
  time frame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
  description: Daily obtained from Activity Tracker wrist band
  measure: Change in Stroop Test Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Using the Stroop test, which measures the average reaction time between incongruent and congruent trials
  measure: Change in N-back Test Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Using the N-back test is a memory task where participants must remember letters from N trials ago.
  measure: Change in Stress Scale Measure Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Stress measured using Perceived Stress Scale measure
  measure: Change in Depression Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Depression measured using Patient Health Questionnaire
  measure: Change in Quality of Life Scale Measures Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Quality of life measured using Quality of Life Scale measures
  measure: Change Social Connectedness Scale-Revised Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Social Connectedness measured using Social Connectedness Scale-Revised
  measure: Change in Rumination Reflection Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Rumination and reflection scales measured using Rumination Reflection Questionnaire
  measure: Change in Brief Strengths Scale Questionnaire Score
  time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
  description: Strengths scale measured using Brief Strengths Scale measures individuals' Temperance Strength, Intellectual Strength, and Interpersonal Strength.
  measure: Change in Sleep Quality Measure
  time frame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
  description: Daily obtained from Activity Tracker wrist band
  arm group label: Meditation group
  arm group type: Experimental
  description: Baseline to week 8:
  Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed.
  Week 8 to week 16:
  Subjects will self report if they choose to continue SOS meditation and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the impact of continued meditation practice on mental health and well being.
  arm group label: Waitlist control
  arm group type: Experimental
  description: Baseline to week 8:
  Subjects will be place in a control group which receives no intervention. However, several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess baseline mental health and well being scores.
  Week 8 to week 16:
  Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed.
  intervention type: Behavioral
  intervention name: SOS Meditation
  description: Focused-attention meditation technique will be used to train participants, specifically the SOS meditation technique. The SOS meditation technique is an easy-to-learn approach where participants are instructed to dissociate their attention from physical awareness, thoughts, and emotions by mentally slowly repeating a calming word or phrase (chosen by the participant themselves).
  SOS Meditation Instructions:
  Close your eyes very gently, in a relaxed way, as you do when we go to sleep
  Your attention should be fully alert. Try not to put any strain on your eyes or try to look up.
  Focus your eyes about eight to ten inches into the field of darkness in front of you on the horizontal plane
  Mentally repeat the (chosen) calming word
  Sit lovingly and calmly to see what comes up, as if you were watching a movie screen and waiting to see what appears on it.
  arm group label: Meditation group
  arm group label: Waitlist control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Manish Saggar, PhD
  role: Principal Investigator
  affiliation: Stanford University
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Manish Saggar
  investigator title: Assistant Professor
  sharing ipd: No