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/NCT06019299</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00008121</org_study_id>
      <nct_id>NCT06019299</nct_id>
    </id_info>
    <brief_title>Cluster-randomized Controlled Trial of Mindfulness-Based Cognitive Therapy Effects on Anxiety and Stress</brief_title>
    <official_title>Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michigan State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Michigan State 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>
        To understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy&#xD;
        intervention delivered using a smartphone application for reducing anxiety and stress within&#xD;
        college students.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this project is to understand the potential effectiveness of a 4 week&#xD;
        Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for&#xD;
        reducing anxiety and stress within college students. Although in-person mindfulness-based&#xD;
        cognitive therapy approaches have been found effective for reducing anxiety and stress; given&#xD;
        the pervasiveness of anxiety and stress in this population, there is a need to provide&#xD;
        alternative and accessible interventions to improve students' mental health. One such&#xD;
        approach may be by leveraging existing tools such Sanvello - a free mindfulness-based&#xD;
        cognitive therapy smartphone application - which could more easily be deployed across a&#xD;
        broader population. Accordingly, using a cluster-randomized controlled design, this&#xD;
        intervention will assess the extent to which 4-weeks of using the Sanvello application was&#xD;
        effective for reducing anxiety and stress within college students.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 21, 2023</start_date>
    <completion_date type="Actual">April 26, 2023</completion_date>
    <primary_completion_date type="Actual">April 26, 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>
      <intervention_model_description>Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>State-Trait Anxiety Inventory</measure>
      <time_frame>Change from baseline, 4 weeks.</time_frame>
      <description>Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress Scale</measure>
      <time_frame>Change from baseline, 4 weeks.</time_frame>
      <description>The Perceived Stress Scale-4 as an index of perceived chronic stress levels</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">289</enrollment>
    <condition>Anxiety</condition>
    <condition>Stress</condition>
    <arm_group>
      <arm_group_label>Positive Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control experimental group received training on the utilization of mindfulness-based stress reduction breathing techniques. Participants were instructed to set a timer for 5 minutes in order to engage in mindfulness breathing. Comprehensive instructions were provided during the initial laboratory time, elucidating the method by which participants were to direct their attention towards their breath. Moreover, participants were encouraged to cultivate a non-judgmental attitude when confronted with potential distractions and to subsequently redirect their focus back to their breathing. Participants were advised to integrate this technique into their daily lives as a means to alleviate anxiety and stress.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mindfulness-Based Cognitive Therapy intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The active experimental group received a mindfulness based cognitive therapy through the Sanvello smartphone application. Participants were encouraged to practice mindfulness daily through the application program &quot;Braving Anxiety,&quot; which consisted of 35 modules. The anxiety management program consists of 1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen - Mindfulness practice.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness Practice</intervention_name>
      <description>Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.</description>
      <arm_group_label>Mindfulness-Based Cognitive Therapy intervention</arm_group_label>
      <arm_group_label>Positive Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Enrolled in course&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Complete inattendance in course during the pretest and study period.&#xD;
  &#xD;
            -  Opted out of data being available for research use&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>42 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Matthew B Pontifex, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Michigan State University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Department of Kinesiology</name>
        <address>
          <city>East Lansing</city>
          <state>Michigan</state>
          <zip>48824</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Michigan State University</investigator_affiliation>
      <investigator_full_name>Matthew B. Pontifex, Ph.D.</investigator_full_name>
      <investigator_title>Professor of Kinesiology and Psychology</investigator_title>
    </responsible_party>
    <keyword>Mindfulness-Based Cognitive Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will be available following primary publication of the results.</ipd_time_frame>
      <ipd_access_criteria>By request and completion of an institutional data-safety and sharing agreement.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 18, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT06019299/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06019299
  org study id: STUDY00008121
  nct id: NCT06019299
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy
        intervention delivered using a smartphone application for reducing anxiety and stress within
        college students.
  The objective of this project is to understand the potential effectiveness of a 4 week
        Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for
        reducing anxiety and stress within college students. Although in-person mindfulness-based
        cognitive therapy approaches have been found effective for reducing anxiety and stress; given
        the pervasiveness of anxiety and stress in this population, there is a need to provide
        alternative and accessible interventions to improve students' mental health. One such
        approach may be by leveraging existing tools such Sanvello - a free mindfulness-based
        cognitive therapy smartphone application - which could more easily be deployed across a
        broader population. Accordingly, using a cluster-randomized controlled design, this
        intervention will assess the extent to which 4-weeks of using the Sanvello application was
        effective for reducing anxiety and stress within college students.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: State-Trait Anxiety Inventory
  time frame: Change from baseline, 4 weeks.
  description: Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety
  measure: Perceived Stress Scale
  time frame: Change from baseline, 4 weeks.
  description: The Perceived Stress Scale-4 as an index of perceived chronic stress levels
  arm group label: Positive Control
  arm group type: Active Comparator
  description: The control experimental group received training on the utilization of mindfulness-based stress reduction breathing techniques. Participants were instructed to set a timer for 5 minutes in order to engage in mindfulness breathing. Comprehensive instructions were provided during the initial laboratory time, elucidating the method by which participants were to direct their attention towards their breath. Moreover, participants were encouraged to cultivate a non-judgmental attitude when confronted with potential distractions and to subsequently redirect their focus back to their breathing. Participants were advised to integrate this technique into their daily lives as a means to alleviate anxiety and stress.
  arm group label: Mindfulness-Based Cognitive Therapy intervention
  arm group type: Experimental
  description: The active experimental group received a mindfulness based cognitive therapy through the Sanvello smartphone application. Participants were encouraged to practice mindfulness daily through the application program "Braving Anxiety," which consisted of 35 modules. The anxiety management program consists of 1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen - Mindfulness practice.
  intervention type: Behavioral
  intervention name: Mindfulness Practice
  description: Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.
  arm group label: Mindfulness-Based Cognitive Therapy intervention
  arm group label: Positive Control
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: 42 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Matthew B Pontifex, PhD
  role: Principal Investigator
  affiliation: Michigan State University
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Michigan State University
  investigator full name: Matthew B. Pontifex, Ph.D.
  investigator title: Professor of Kinesiology and Psychology
  mesh term: Anxiety Disorders
  sharing ipd: Yes
  ipd description: Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will be available following primary publication of the results.
  ipd access criteria: By request and completion of an institutional data-safety and sharing agreement.
  provided document: 