<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/NCT02226042</url>
  </required_header>
  <id_info>
    <org_study_id>MBCTMechanisms</org_study_id>
    <nct_id>NCT02226042</nct_id>
  </id_info>
  <brief_title>Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)</brief_title>
  <official_title>Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research will investigate the neuropsychological mechanisms underlying the eight-week&#xD;
      Mindfulness-based Cognitive Therapy (MBCT) programme.&#xD;
&#xD;
      Participants in remission from depression will be seen pre- and post-MBCT to assess the&#xD;
      underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess&#xD;
      the relationship of these neuropsychological changes with relapse risk.&#xD;
&#xD;
      The research will focus primarily on changes in self-compassion, rumination, attention and&#xD;
      structural brain changes, with secondary focus on other mechanisms of emotional processing&#xD;
      and memory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There will be three groups in total.&#xD;
&#xD;
        -  The first group will take 36 participants in remission from major depression (rMDD)&#xD;
           through the 8 week MBCT program.&#xD;
&#xD;
        -  A control group of 36 rMDD participants will not receive the intervention.&#xD;
&#xD;
        -  A group of never depressed healthy control participants will also be recruited.&#xD;
&#xD;
      Research visits for participants not undergoing MBCT will be separated by an 8 week gap.&#xD;
&#xD;
      All participants will be seen before and after the 8 weeks for completion of&#xD;
      neuropsychological assessments and questionnaires.&#xD;
&#xD;
      rMDD participants will be followed up over the following 12 months to identify any predictors&#xD;
      of relapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures</measure>
    <time_frame>measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)</time_frame>
    <description>Two neuropsychological measures of self-compassion have been developed and will be administerat baseline and after MBCT/8 week gap (8 weeks post baseline). Self-report questionnaires will be administered before and after MBCT/8 week gap and at subsequent follow-up visits (3, 6, 12 months).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures</measure>
    <time_frame>measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total)</time_frame>
    <description>One neuropsychological measure of rumination has been developed and will be administered at baseline and immediately after MBCT/8 week gap (8 weeks post baseline).&#xD;
Self-report questionnaires will be administered at baseline and after MBCT/8 week gap (8 weeks post baseline) and at subsequent follow-up visits (3,6,12 months).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in attention regulation following MBCT</measure>
    <time_frame>measured at baseline and after the intervention/8 week gap (8 weeks post baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in brain structure following MBCT</measure>
    <time_frame>measured at baseline and after the intervention (8 weeks post baseline)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in emotional processing</measure>
    <time_frame>measured at baseline and after the intervention/8 week gap (8 weeks post baseline)</time_frame>
    <description>Other neuropsychological assessments of emotional processing (face emotion recognition, memory, cognitive flexibility) will be assessed at baseline and after MBCT/8 week gap (8 weeks post baseline).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Major Depression (in Remission)</condition>
  <arm_group>
    <arm_group_label>Mindfulness-based Cognitive Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals currently in remission from depression will choose to enter the Mindfulness-based Cognitive Therapy (MBCT) arm and undergo the 8 week MBCT group programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-MBCT arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals who have never experienced major depression</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based Cognitive Therapy</intervention_name>
    <description>MBCT: Mindfulness-based Cognitive Therapy is an 8 week group-based programme consisting of approximately 12 participants per group. There is also a full one day of practice around week 6. MBCT was initially designed for individuals in remission from depression and at risk of relapsing. The intervention is a mix of mindfulness meditation, cognitive behavioural therapy exercises and psychoeducation. MBCT has been shown to be effective in reducing relapse risk over 12 months.</description>
    <arm_group_label>Mindfulness-based Cognitive Therapy</arm_group_label>
    <other_name>MBCT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants with remitted depression (rMDD):&#xD;
&#xD;
          -  At least two previous episodes of DSM-IV major depression in adulthood, diagnosed&#xD;
             using the Mini International Neuropsychiatric Interview (M.I.N.I).&#xD;
&#xD;
          -  Full or partial remission for at least three months with two depressive episodes&#xD;
             within the last five years.&#xD;
&#xD;
          -  A score of less than or equal to 12 on the Montgomery Asberg Depression Rating Scale&#xD;
             (MADRS) mood assessment.&#xD;
&#xD;
          -  If on medication, no recent or planned major changes&#xD;
&#xD;
        Healthy volunteers:&#xD;
&#xD;
          -  In good psychological health screened with the M.I.N.I&#xD;
&#xD;
        All participants:&#xD;
&#xD;
          -  in good physical health (to reduce risk of confounding physical health problems).&#xD;
&#xD;
          -  sufficiently fluent in English to ensure valid understanding and completion of the&#xD;
             tasks.&#xD;
&#xD;
          -  minimum I.Q level of 80 to ensure sufficient understanding of the neurocognitive tasks&#xD;
             administered.&#xD;
&#xD;
          -  colour vision and acuity within normal/corrected to normal limits.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Any current mental health diagnosis (DSM-IV diagnosis including current major&#xD;
             depression, bipolar disorder, psychosis, Obsessive Compulsive Disorder (OCD),&#xD;
             substance abuse or dependence, eating disorders)&#xD;
&#xD;
          -  Physical health or neurological disorders that might interfere with the interpretation&#xD;
             of the tasks, including a history of significant head injury.&#xD;
&#xD;
          -  In addition healthy volunteers will be without a history mental health disorders&#xD;
             (DSM-IV)&#xD;
&#xD;
          -  Current or previous experience of mindfulness-based treatments or extensive cognitive&#xD;
             behavioural treatment, or planned participation in psychological treatments during the&#xD;
             key time for the study (between pre and post visits).&#xD;
&#xD;
          -  Planned major alteration in drug treatment for depression between pre and post visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Manchester</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M13 9PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Kate Williams</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder, Major</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/NCT02226042
org study id: MBCTMechanisms
nct id: NCT02226042
lead sponsor: 
has dmc: No
This research will investigate the neuropsychological mechanisms underlying the eight-week
      Mindfulness-based Cognitive Therapy (MBCT) programme.

      Participants in remission from depression will be seen pre- and post-MBCT to assess the
      underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess
      the relationship of these neuropsychological changes with relapse risk.

      The research will focus primarily on changes in self-compassion, rumination, attention and
      structural brain changes, with secondary focus on other mechanisms of emotional processing
      and memory.
There will be three groups in total.

        -  The first group will take 36 participants in remission from major depression (rMDD)
           through the 8 week MBCT program.

        -  A control group of 36 rMDD participants will not receive the intervention.

        -  A group of never depressed healthy control participants will also be recruited.

      Research visits for participants not undergoing MBCT will be separated by an 8 week gap.

      All participants will be seen before and after the 8 weeks for completion of
      neuropsychological assessments and questionnaires.

      rMDD participants will be followed up over the following 12 months to identify any predictors
      of relapse.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures
time frame: measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)
description: Two neuropsychological measures of self-compassion have been developed and will be administerat baseline and after MBCT/8 week gap (8 weeks post baseline). Self-report questionnaires will be administered before and after MBCT/8 week gap and at subsequent follow-up visits (3, 6, 12 months).
measure: Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures
time frame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total)
description: One neuropsychological measure of rumination has been developed and will be administered at baseline and immediately after MBCT/8 week gap (8 weeks post baseline).
Self-report questionnaires will be administered at baseline and after MBCT/8 week gap (8 weeks post baseline) and at subsequent follow-up visits (3,6,12 months).
measure: Changes in attention regulation following MBCT
time frame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
measure: Changes in brain structure following MBCT
time frame: measured at baseline and after the intervention (8 weeks post baseline)
measure: Changes in emotional processing
time frame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
description: Other neuropsychological assessments of emotional processing (face emotion recognition, memory, cognitive flexibility) will be assessed at baseline and after MBCT/8 week gap (8 weeks post baseline).
arm group label: Mindfulness-based Cognitive Therapy
arm group type: Experimental
description: Individuals currently in remission from depression will choose to enter the Mindfulness-based Cognitive Therapy (MBCT) arm and undergo the 8 week MBCT group programme
arm group label: Non-MBCT arm
arm group type: No Intervention
description: Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme
arm group label: Healthy volunteers
arm group type: No Intervention
description: Individuals who have never experienced major depression
intervention type: Behavioral
intervention name: Mindfulness-based Cognitive Therapy
description: MBCT: Mindfulness-based Cognitive Therapy is an 8 week group-based programme consisting of approximately 12 participants per group. There is also a full one day of practice around week 6. MBCT was initially designed for individuals in remission from depression and at risk of relapsing. The intervention is a mix of mindfulness meditation, cognitive behavioural therapy exercises and psychoeducation. MBCT has been shown to be effective in reducing relapse risk over 12 months.
arm group label: Mindfulness-based Cognitive Therapy
other name: MBCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Kate Williams
investigator title: PhD Student
mesh term: Depressive Disorder, Major
sharing ipd: No