<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/NCT03035669</url>
  </required_header>
  <id_info>
    <org_study_id>HumboldtUB</org_study_id>
    <nct_id>NCT03035669</nct_id>
  </id_info>
  <brief_title>Effects of Mindfulness Training on Emotion Regulation and Social Cognition.</brief_title>
  <acronym>MFN&amp;SOCCOG</acronym>
  <official_title>Effects of Mindfulness Training on Emotion Regulation and Social Cognition, a Psychophysiological and Neuroimaging Randomized Controled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humboldt-Universität zu Berlin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Comisión Nacional de Investigación Científica y Tecnológica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Humboldt-Universität zu Berlin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study will investigate the effects of a mindfulness training on emotion&#xD;
      regulation and social cognition, using several psychological, behavioral, psychophysiological&#xD;
      and neuroimaging methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the present study is to evaluate the impact of a mindfulness intervention,&#xD;
      particularly the mindfulness-based stress reduction (MBSR), on the capacities of emotion&#xD;
      regulation and social cognition, in caring/helping professions which are vulnerable to&#xD;
      stress. In the context of a longitudinal intervention study, a randomized controlled trial,&#xD;
      the efficacy of the MBSR to increase the capacity for self-emotion regulation, empathic&#xD;
      attunement, and compassion capacities will be measured. For doing this, several&#xD;
      psychological, behavioral, psychophysiological and neuroimaging brain measurements will be&#xD;
      used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Activation changes in emotions related brain regions. Measured by significant changes in the BOLD (blood oxygenated level dependent) signal from task based functional magnetic resonance imaging.</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in resting state functional connectivity within brain networks. Measured by significant changes in intrinsic functional connectivity parameters, estimated from the resting state BOLD signal, during functional magnetic resonance imaging.</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in resting state functional connectivity between inter-networks connectivity.</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
    <description>Changes between brain networks connectivity (including DMN, fronto-parietal and salience networks), measured as significant changes in inter-networks connectivity parameters estimated from the temporal correlation of intrinsic functional connectivity networks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in regional brain morphometry in stress processing related areas. Measured by significant changes in regional grey matter density estimated from structural magnetic resonance imaging.</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural tasks: mind-wandering task</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
    <description>Changes in mind-wandering task, measured as changes in task-unrelated thoughts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in personality functioning.</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
    <description>Significant changes in levels of personality functioning measured by the operationalized psychodynamic diagnosis scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experience Sampling of emotional tolerance</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, last acquisition period during 3 weeks after the intervention. And during the intervention period everyday.</time_frame>
    <description>Significant changes in self-reported capacity for emotion tolerance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychophysiological measurements of stress (sympathetic component)</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
    <description>Activation changes in psychophysiological stress parameters using Skin Conductance Response (measured as significant changes in tonic and phasic response levels) during an emotion regulation task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychophysiological measurements of stress (vagal component)</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
    <description>Activation changes in psychophysiological stress parameters using Heart Rate Variability (power analysis of high frequency sub-bands of heart rate spectrum), during an emotion regulation task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural tasks: empathy test.</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
    <description>Changes in empathy test, measured as changes in levels of cognitive and affective empathy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-reported affective states</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
    <description>Significant changes in self-reported levels of negative and positive affects measured by the PANAS scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in social functioning</measure>
    <time_frame>first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.</time_frame>
    <description>Significant changes in the interpersonal competence questionnaire self-reported scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Emotional Stress</condition>
  <condition>Social Cognition</condition>
  <condition>Mindfulness</condition>
  <arm_group>
    <arm_group_label>Mindfulness group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness based stress reduction: 8 week program, including meditation, body-awareness, and yoga practices. Daily assignments and home practices during 50 minutes per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reading group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reading and sharing group: 8 week program, including readings, interpersonal exchanges, group discussion, listening and role playing exercises. Daily assignments and home practices during 50 minutes per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness group</intervention_name>
    <description>8 week program</description>
    <arm_group_label>Mindfulness group</arm_group_label>
    <other_name>mindfulness based stress reduction</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reading group</intervention_name>
    <description>8 week program</description>
    <arm_group_label>Reading group</arm_group_label>
    <other_name>Reading and sharing group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers: Men or women&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Normal or corrected-to-normal visión&#xD;
&#xD;
          -  German as a first language&#xD;
&#xD;
          -  No history of neurological or psychiatric problems, or use of controlled medication&#xD;
             that might interfere with emotion or attention.&#xD;
&#xD;
          -  No symptoms of claustrophobia&#xD;
&#xD;
          -  Written informed consent form to participate in the study and neuro-imaging&#xD;
             experiment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemical dependence, including nicotine and alcohol&#xD;
&#xD;
          -  Dementia or psychotic condition.&#xD;
&#xD;
          -  Depression or use of antidepressants&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Prior MBSR class or regularly practicing mindfulness meditation (or yoga) for three or&#xD;
             more months.&#xD;
&#xD;
          -  Non-controlled severe medical disease that might interfere with the performance of the&#xD;
             study, such as neoplasias, cardiopathies, digestive pathologies, diabetes mellitus&#xD;
             type I or type II&#xD;
&#xD;
          -  Neoplasias in the central nervous system&#xD;
&#xD;
          -  Tremor or dystonia in cephalic segment that hinders the performance of the MRI study&#xD;
             (tremor equal to or higher than 3 in each corporal segment, according to the UPDRS&#xD;
             scale)&#xD;
&#xD;
          -  Fulfillment of any criterion of contraindication for the MRI exam (for instance,&#xD;
             metallic implants, claustrophobia, pregnancy, use of pacemaker; intracranial aneurism&#xD;
             clip; cochlear implants).&#xD;
&#xD;
          -  Presence of odontological devices that might disturb the magnetic field or any sources&#xD;
             of variation of the magnetic susceptibility&#xD;
&#xD;
          -  Any other conditions the investigator might deem problematic for the inclusion of the&#xD;
             volunteer in a trial of this nature will also be considered.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabel Dziobek, Professor, PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Humboldt Universität.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Isabel Dziobek, Professor, PhD.</last_name>
    <phone>(030) 2093-6186</phone>
    <email>isabel.dziobek@hu-berlin.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Simon Guendelman, MD.</last_name>
    <phone>(030) 2093-6186</phone>
    <email>simon.guendelman@hu-berlin.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Berlin School of Mind &amp; Brain, Humboldt Universität.</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon Guendelman, MD</last_name>
      <phone>(030) 2093-6186</phone>
      <email>simon.guendelman@hu-berlin.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.mabstudy.de</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Humboldt-Universität zu Berlin</investigator_affiliation>
    <investigator_full_name>Simon Guendelman</investigator_full_name>
    <investigator_title>Medical doctor, doctorate candidate.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</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/NCT03035669
org study id: HumboldtUB
nct id: NCT03035669
lead sponsor: 
collaborator: 
has dmc: No
The present study will investigate the effects of a mindfulness training on emotion
      regulation and social cognition, using several psychological, behavioral, psychophysiological
      and neuroimaging methods.
The aim of the present study is to evaluate the impact of a mindfulness intervention,
      particularly the mindfulness-based stress reduction (MBSR), on the capacities of emotion
      regulation and social cognition, in caring/helping professions which are vulnerable to
      stress. In the context of a longitudinal intervention study, a randomized controlled trial,
      the efficacy of the MBSR to increase the capacity for self-emotion regulation, empathic
      attunement, and compassion capacities will be measured. For doing this, several
      psychological, behavioral, psychophysiological and neuroimaging brain measurements will be
      used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Activation changes in emotions related brain regions. Measured by significant changes in the BOLD (blood oxygenated level dependent) signal from task based functional magnetic resonance imaging.
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Changes in resting state functional connectivity within brain networks. Measured by significant changes in intrinsic functional connectivity parameters, estimated from the resting state BOLD signal, during functional magnetic resonance imaging.
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Changes in resting state functional connectivity between inter-networks connectivity.
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
description: Changes between brain networks connectivity (including DMN, fronto-parietal and salience networks), measured as significant changes in inter-networks connectivity parameters estimated from the temporal correlation of intrinsic functional connectivity networks.
measure: Changes in regional brain morphometry in stress processing related areas. Measured by significant changes in regional grey matter density estimated from structural magnetic resonance imaging.
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
measure: Behavioural tasks: mind-wandering task
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
description: Changes in mind-wandering task, measured as changes in task-unrelated thoughts.
measure: Changes in personality functioning.
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
description: Significant changes in levels of personality functioning measured by the operationalized psychodynamic diagnosis scale.
measure: Experience Sampling of emotional tolerance
time frame: first acquisition period during 3 weeks before the intervention, last acquisition period during 3 weeks after the intervention. And during the intervention period everyday.
description: Significant changes in self-reported capacity for emotion tolerance.
measure: Changes in psychophysiological measurements of stress (sympathetic component)
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
description: Activation changes in psychophysiological stress parameters using Skin Conductance Response (measured as significant changes in tonic and phasic response levels) during an emotion regulation task.
measure: Changes in psychophysiological measurements of stress (vagal component)
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
description: Activation changes in psychophysiological stress parameters using Heart Rate Variability (power analysis of high frequency sub-bands of heart rate spectrum), during an emotion regulation task.
measure: Behavioural tasks: empathy test.
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
description: Changes in empathy test, measured as changes in levels of cognitive and affective empathy.
measure: Changes in self-reported affective states
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
description: Significant changes in self-reported levels of negative and positive affects measured by the PANAS scale.
measure: Changes in social functioning
time frame: first acquisition period during 3 weeks before the intervention, second acquisition period during 3 weeks after the intervention.
description: Significant changes in the interpersonal competence questionnaire self-reported scale.
arm group label: Mindfulness group
arm group type: Experimental
description: Mindfulness based stress reduction: 8 week program, including meditation, body-awareness, and yoga practices. Daily assignments and home practices during 50 minutes per day.
arm group label: Reading group
arm group type: Active Comparator
description: Reading and sharing group: 8 week program, including readings, interpersonal exchanges, group discussion, listening and role playing exercises. Daily assignments and home practices during 50 minutes per day.
intervention type: Behavioral
intervention name: Mindfulness group
description: 8 week program
arm group label: Mindfulness group
other name: mindfulness based stress reduction
intervention type: Behavioral
intervention name: Reading group
description: 8 week program
arm group label: Reading group
other name: Reading and sharing group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Isabel Dziobek, Professor, PhD.
role: Study Chair
affiliation: Humboldt Universität.
last name: Isabel Dziobek, Professor, PhD.
phone: (030) 2093-6186
email: isabel.dziobek@hu-berlin.de
last name: Simon Guendelman, MD.
phone: (030) 2093-6186
email: simon.guendelman@hu-berlin.de
facility: 
status: Recruiting
contact: 
country: Germany
url: http://www.mabstudy.de
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Humboldt-Universität zu Berlin
investigator full name: Simon Guendelman
investigator title: Medical doctor, doctorate candidate.
mesh term: Stress, Psychological
sharing ipd: No