<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/NCT02200341</url>
  </required_header>
  <id_info>
    <org_study_id>2014P000223</org_study_id>
    <secondary_id>K01AT008225</secondary_id>
    <nct_id>NCT02200341</nct_id>
  </id_info>
  <brief_title>Effects of Mindfulness-based Cognitive Therapy on Brain Mechanisms in Depression</brief_title>
  <official_title>MBCT Effects on Brain Mechanisms of Interoceptive Awareness and Rumination in MDD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of Mindfulness-Based Cognitive&#xD;
      Therapy (MBCT) on brain mechanisms associated with interoceptive awareness and rumination in&#xD;
      individuals suffering from major depressive disorder (MDD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">December 15, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>brain activation in regions of interest</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Brain activation will be measured with functional magnetic resonance imaging (fMRI) during two different tasks: an interoceptive attention task and a rumination task.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Mindfulness-Based Cognitive Therapy (MBCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness-Based Cognitive Therapy (MBCT) 8-week intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Progressive Relaxation Training - Psychoeducation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Progressive Relaxation Training and Psychoeducation (PRT-PsyEd) 8-week intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MBCT</intervention_name>
    <arm_group_label>Mindfulness-Based Cognitive Therapy (MBCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PRT-PsyEd</intervention_name>
    <arm_group_label>Progressive Relaxation Training - Psychoeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  current mild-to-moderate depression symptoms (score 12-36 on IDS-C30)&#xD;
&#xD;
          -  history of at least 3 depressive episodes or history of 2 years of depression symptoms&#xD;
&#xD;
          -  on either no pharmacological treatment or on maintenance antidepressant treatment for&#xD;
             at least 8 weeks before the start of the intervention&#xD;
&#xD;
          -  English literacy&#xD;
&#xD;
          -  normal or near-normal vision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i. A score of 37 of higher on the Inventory of Depressive Symptomatology - Clinician&#xD;
        version (IDS-C30).&#xD;
&#xD;
        ii. Significant risk for suicide, defined by a score of 3 on Item 18 in the IDS-C30, or as&#xD;
        assessed by evaluating clinician.&#xD;
&#xD;
        iii. Severe and unstable medical illness including cardiovascular, hepatic, renal,&#xD;
        respiratory, endocrine, neurological, or hematological disease.&#xD;
&#xD;
        iv. The following DSM disorders: any bipolar disorder (current or past), a primary&#xD;
        psychotic disorder (current or past), or current psychotic symptoms. However, entry of&#xD;
        patients with anxiety disorder(s) will be permitted if the depressive disorder is judged to&#xD;
        be the predominant disorder.&#xD;
&#xD;
        v. Active diagnosis of substance abuse or dependence disorders within the last 3 months.&#xD;
&#xD;
        vi. General conditions that would impede participation in a group intervention, as assessed&#xD;
        by the evaluating clinician or the therapist delivering the MBCT intervention (such as&#xD;
        severe characterological disorders, cognitive impairment, tendencies toward physical&#xD;
        aggression).&#xD;
&#xD;
        vii. Past or current training in mindfulness (MBCT, Mindfulness-Based Stress Reduction) or&#xD;
        in the Relaxation Response.&#xD;
&#xD;
        viii. Significant training in meditation (or related practices), i.e., more than 10&#xD;
        meditation classes in the past 3 months, or more than 10 classes in yoga, Tai Chi, or Qi&#xD;
        Gong in the past 3 months.&#xD;
&#xD;
        ix. Currently taking any psychoactive drugs (whether prescription, over-the-counter, or&#xD;
        recreational) other than prescribed antidepressants. This restriction includes the&#xD;
        following supplements: Hypericum perforatum (St. John's wort), Valeriana officinalis&#xD;
        (valerian), and 5-Hydroxytryptophan (5-HTP).&#xD;
&#xD;
        x. Any change in type or dosage of treatment (whether with antidepressant medication or&#xD;
        with psychotherapy or psychosocial intervention) in the 8 weeks preceding the start of the&#xD;
        intervention.&#xD;
&#xD;
        xi. Standard exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures&#xD;
        for research purposes, i.e., Meniere's disease, epilepsy, claustrophobia, currently&#xD;
        pregnant or breastfeeding or planning to conceive or breastfeed during the study, cardiac&#xD;
        pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants,&#xD;
        non-MR-compatible implants or devices.&#xD;
&#xD;
        xii. 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, or&#xD;
        known structural brain lesion).&#xD;
&#xD;
        xiii. Unable or unwilling to fill in online questionnaires or to be contacted over the&#xD;
        phone by study staff for periodic assessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gaelle Desbordes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Desbordes, Gaelle</investigator_full_name>
    <investigator_title>Instructor in Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT02200341
org study id: 2014P000223
secondary id: K01AT008225
nct id: NCT02200341
lead sponsor: 
collaborator: 
The purpose of this study is to investigate the effects of Mindfulness-Based Cognitive
      Therapy (MBCT) on brain mechanisms associated with interoceptive awareness and rumination in
      individuals suffering from major depressive disorder (MDD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: brain activation in regions of interest
time frame: baseline and 8 weeks
description: Brain activation will be measured with functional magnetic resonance imaging (fMRI) during two different tasks: an interoceptive attention task and a rumination task.
arm group label: Mindfulness-Based Cognitive Therapy (MBCT)
arm group type: Experimental
description: Mindfulness-Based Cognitive Therapy (MBCT) 8-week intervention
arm group label: Progressive Relaxation Training - Psychoeducation
arm group type: Active Comparator
description: Progressive Relaxation Training and Psychoeducation (PRT-PsyEd) 8-week intervention
intervention type: Behavioral
intervention name: MBCT
arm group label: Mindfulness-Based Cognitive Therapy (MBCT)
intervention type: Behavioral
intervention name: PRT-PsyEd
arm group label: Progressive Relaxation Training - Psychoeducation
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gaelle Desbordes, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Desbordes, Gaelle
investigator title: Instructor in Radiology
mesh term: Depression
mesh term: Depressive Disorder