<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/NCT02972853</url>
  </required_header>
  <id_info>
    <org_study_id>CHA-IRB-1002/08/14</org_study_id>
    <secondary_id>1UH2AT009145-01</secondary_id>
    <nct_id>NCT02972853</nct_id>
  </id_info>
  <brief_title>Mindful Self-Regulation fMRI Pilot Study</brief_title>
  <acronym>MindfulPCMRI</acronym>
  <official_title>Mindfulness Influences on Self-Regulation: Mental and Physical Health Implications: Mindful Self-Regulation fMRI Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge Health Alliance</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Martinos Center for Biomedical Imaging</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge Health Alliance</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to 1) determine whether Mindfulness Training for Primary Care&#xD;
      (see study &quot;MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A&#xD;
      Pilot Study&quot;) engages self-regulation targets such as emotion regulation, attention, and&#xD;
      interoceptive awareness; and 2) changes brain activation in neuroimaging tasks before&#xD;
      compared to after the training. Neuroimaging fMRI tasks probe mechanisms related to&#xD;
      self-regulation, such as attention/inhibition, emotion regulation, self-compassion,&#xD;
      interoception and pain regulation.&#xD;
&#xD;
      The study will also look at whether chronic disease self-management and successful engagement&#xD;
      of self-report and behavioral self-regulation targets (emotion regulation, attention, and&#xD;
      interoceptive awareness) relates to the observed brain activation changes after compared to&#xD;
      before the mindfulness intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to test brain activation changes related to self-regulation targets of&#xD;
      attention, emotion regulation, self-compassion, interoception and pain regulation that are&#xD;
      influenced by mindfulness training within primary care (compare MINDFUL-PC study).&#xD;
&#xD;
      The study will also look at whether successful chronic disease self-management relates to the&#xD;
      observed brain activation changes after compared to before the mindfulness intervention.&#xD;
&#xD;
      The study will examine the relationship between mindfulness training within primary care and&#xD;
      medical regimen adherence (initiation and maintenance) as well as the underlying neural&#xD;
      correlates associated with changes in self-regulation.&#xD;
&#xD;
      This is a single-arm pilot trial, recruiting from a randomized controlled trial (see&#xD;
      MINDFUL-PC study). .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">October 2020</completion_date>
  <primary_completion_date type="Actual">June 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Brain activation in regions of interest</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in brain activation will be measured with functional magnetic resonance imaging (fMRI) during four different tasks: an affective go/nogo regulation task, an interoceptive attention task, a self-compassion task and a pain regulation task. Brain activation will be compared between baseline and Week 8.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlations between brain activation changes and self-regulation measures</measure>
    <time_frame>8 weeks</time_frame>
    <description>Self-regulation targets of emotion regulation, interoceptive awareness, and attention from MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations between brain activation changes and chronic disease self-management action plan initiation.</measure>
    <time_frame>9 weeks</time_frame>
    <description>In addition, brain activation in regions of interest will be correlated with chronic disease self-management action plan initiation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Psychiatric Problem</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Neuroimaging</condition>
  <condition>Self-Control</condition>
  <arm_group>
    <arm_group_label>Mindfulness Training for Primary Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For intervention description see Mindfulness Training for Primary Care (MTPC) in the study &quot;MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study&quot;. For the Mindfulness Training for Primary Care (MTPC) fMRI - arm, we acquire pre-/post-intervention neuroimaging measures from subjects enrolled in this additional pilot fMRI study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Training for Primary Care (MTPC)</intervention_name>
    <description>For intervention description see Mindfulness Training for Primary Care (MTPC) in the study &quot;MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study&quot;</description>
    <arm_group_label>Mindfulness Training for Primary Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 21-60 years old enrolled for participation in the MINDFUL-PC study.&#xD;
&#xD;
          -  During baseline visit, patient has a history of either major depressive disorder,&#xD;
             dysthymia, or generalized anxiety disorder, OR has current mild to moderate symptoms&#xD;
             of depression (score range of 10-28 on DASS-21 Depression subscale) or anxiety (score&#xD;
             &gt;7 on DASS-21 anxiety subscale).&#xD;
&#xD;
          -  Participant does not have a substance use disorder nor intoxication at the time of&#xD;
             scanning. Participants must report no more than infrequent recreational cannabis use&#xD;
             (i.e., no more than two times a month) and must report capacity for abstinence from&#xD;
             both cannabis and ethyl alcohol for the 72 hours prior to the scan.&#xD;
&#xD;
          -  Normal or corrected-to-normal vision, and correction must be with contact lenses.&#xD;
&#xD;
          -  Right-handed as defined by Edinburgh Handedness Inventory.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current severe panic disorder, active severe PTSD symptoms, or psychosis.&#xD;
&#xD;
          -  Current suicidality OR severe depression as evidenced by a score of 28 or higher on&#xD;
             the DASS-21 Depression subscale.&#xD;
&#xD;
          -  Standard direct exclusion criteria for undergoing magnetic resonance imaging (MRI)&#xD;
             procedures for research purposes (safety standards), i.e., Meniere's disease,&#xD;
             epilepsy, strong claustrophobia, currently pregnant or breastfeeding or planning to&#xD;
             conceive or breastfeed during the study, cardiac pacemaker, prosthetic heart valve,&#xD;
             neurostimulator, implanted pumps, non-MR-compatible implants or devices.&#xD;
&#xD;
          -  A history of neurological disease or injury, including a history of seizures or&#xD;
             significant head trauma (i.e., extended loss of consciousness, neurological sequelae,&#xD;
             or known structural brain lesion), or previous brain surgery.&#xD;
&#xD;
          -  Severe skin disease, skin allergies, or multiple reactions to topical preparations,&#xD;
             dressings or tapes.&#xD;
&#xD;
          -  Current meditation or intense yoga practice or extensive previous experience.&#xD;
&#xD;
          -  Participants with vascular disease, such as peripheral vascular disease, varicose&#xD;
             veins, or lymphedema, in both lower limbs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zev D Schuman-Olivier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cambridge Health Alliance</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHA Center for Mindfulness and Compassion</name>
      <address>
        <city>Somerville</city>
        <state>Massachusetts</state>
        <zip>02143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02972853
org study id: CHA-IRB-1002/08/14
secondary id: 1UH2AT009145-01
nct id: NCT02972853
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to 1) determine whether Mindfulness Training for Primary Care
      (see study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A
      Pilot Study") engages self-regulation targets such as emotion regulation, attention, and
      interoceptive awareness; and 2) changes brain activation in neuroimaging tasks before
      compared to after the training. Neuroimaging fMRI tasks probe mechanisms related to
      self-regulation, such as attention/inhibition, emotion regulation, self-compassion,
      interoception and pain regulation.

      The study will also look at whether chronic disease self-management and successful engagement
      of self-report and behavioral self-regulation targets (emotion regulation, attention, and
      interoceptive awareness) relates to the observed brain activation changes after compared to
      before the mindfulness intervention.
This study aims to test brain activation changes related to self-regulation targets of
      attention, emotion regulation, self-compassion, interoception and pain regulation that are
      influenced by mindfulness training within primary care (compare MINDFUL-PC study).

      The study will also look at whether successful chronic disease self-management relates to the
      observed brain activation changes after compared to before the mindfulness intervention.

      The study will examine the relationship between mindfulness training within primary care and
      medical regimen adherence (initiation and maintenance) as well as the underlying neural
      correlates associated with changes in self-regulation.

      This is a single-arm pilot trial, recruiting from a randomized controlled trial (see
      MINDFUL-PC study). .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Brain activation in regions of interest
time frame: 8 weeks
description: Change in brain activation will be measured with functional magnetic resonance imaging (fMRI) during four different tasks: an affective go/nogo regulation task, an interoceptive attention task, a self-compassion task and a pain regulation task. Brain activation will be compared between baseline and Week 8.
measure: Correlations between brain activation changes and self-regulation measures
time frame: 8 weeks
description: Self-regulation targets of emotion regulation, interoceptive awareness, and attention from MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home."
measure: Correlations between brain activation changes and chronic disease self-management action plan initiation.
time frame: 9 weeks
description: In addition, brain activation in regions of interest will be correlated with chronic disease self-management action plan initiation.
arm group label: Mindfulness Training for Primary Care
arm group type: Experimental
description: For intervention description see Mindfulness Training for Primary Care (MTPC) in the study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study". For the Mindfulness Training for Primary Care (MTPC) fMRI - arm, we acquire pre-/post-intervention neuroimaging measures from subjects enrolled in this additional pilot fMRI study.
intervention type: Behavioral
intervention name: Mindfulness Training for Primary Care (MTPC)
description: For intervention description see Mindfulness Training for Primary Care (MTPC) in the study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study"
arm group label: Mindfulness Training for Primary Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Zev D Schuman-Olivier, MD
role: Principal Investigator
affiliation: Cambridge Health Alliance
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No