<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/NCT02191553</url>
  </required_header>
  <id_info>
    <org_study_id>PI13/0129</org_study_id>
    <nct_id>NCT02191553</nct_id>
  </id_info>
  <brief_title>Differential Effect of Four Mindfulness Exercises</brief_title>
  <official_title>Differential Effect of Four Mindfulness Exercises on Mindfulness, Cerebral Cartography and Heart Ratio Variability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Miguel Servet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Miguel Servet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mindfulness can be considered as a family of complex attentional and emotional regulation&#xD;
      strategies that promote the cultivation of well-being and emotional balance. The practice of&#xD;
      mindfulness produces the development of a consciousness that unfolds moment to moment, open&#xD;
      and unprejudiced in the present moment, here and now. Despite its extensive benefits, the&#xD;
      practice of mindfulness requires a significant commitment in time and effort, which limits&#xD;
      the potential for its dissemination. The studies to narrow the differential effects of the&#xD;
      various exercises based on mindfulness, will further enhance their effectiveness and they can&#xD;
      guide the practice sequence according to user needs. In this paper we will research&#xD;
      mindfulness electroencephalographic correlates of as four different exercise programs&#xD;
      included in mindfulness-based cognitive therapy (MBCT) and stress reduction program based on&#xD;
      mindfulness (MBSR) as well as its effect on several psychological variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mindfulness is a way of using attention intentionally, repeatedly reactivating the&#xD;
      attentional focus, so that it enhances the ability of sustained attention. It involves a&#xD;
      complex process of self-regulation and inhibition of internal and external stimuli&#xD;
      interferences.&#xD;
&#xD;
      Although the overall effects of meditation on brain bioelectrical signals are still being&#xD;
      characterized, there is some consensus on the fact that meditation helps alter brain activity&#xD;
      in both state and trait.&#xD;
&#xD;
      The specific aim of this study is to assess the differential effect of four different&#xD;
      practices of mindfulness in psychological well-being and their corresponding&#xD;
      neurophysiological correlates.&#xD;
&#xD;
      The hypothesis is that different exercises within the range of mindfulness practices exert&#xD;
      different effects in terms of electroencephalographic activity, expecting different band&#xD;
      increases in alpha (activity 7-to 2 Hz), beta (activity more than 13 Hz), theta (activity 4-6&#xD;
      Hz) and delta (activity less than 3 Hz) respectively, as well as changes in the&#xD;
      lateralization of the activity (left or right hemisphere). We also expect an improvement in&#xD;
      the variables such as mindfulness, self-compassion, positive affect, anxiety, depression and&#xD;
      sleep quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Different facets of Mindfulness</measure>
    <time_frame>3 months</time_frame>
    <description>The Five Facets Mindfulness Questionnaire (FFMQ) will be used: It assesses the following facets of mindfulness: Observing, describing, acting with awareness, non judging of inner experience and non-reactivity to inner experience</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain function</measure>
    <time_frame>3 months</time_frame>
    <description>We will use cerebral cartography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affectivity</measure>
    <time_frame>3 months</time_frame>
    <description>It will be measured with PANAS questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety and depression</measure>
    <time_frame>3 months</time_frame>
    <description>Measured with Hospital Anxiety Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>3 months</time_frame>
    <description>Measured with Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-compassion</measure>
    <time_frame>3 months</time_frame>
    <description>Measured with Self-Compassion Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>heart function and heart variability rate</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators will use electrocardiogram</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Well-being</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Control Group: Relaxation Techniques</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Relaxation techniques which do not involve either formal or informal mindfulness training. Subjects in this group practice Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loving Kindness Meditation (Metta)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Loving-kindness meditation following Kristin Neff protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Body Scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Body scan as described in standard MBSR protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitting Practice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sitting practice as mindfulness meditation described in standard MBSR protocols.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group relaxation techniques</intervention_name>
    <description>Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.</description>
    <arm_group_label>Control Group: Relaxation Techniques</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Loving-kindness meditation</intervention_name>
    <description>Following Kristin Neff protocol</description>
    <arm_group_label>Loving Kindness Meditation (Metta)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Body scan</intervention_name>
    <description>Body scan: Attention being directed with detailed awareness to every part of the body for a sustained period of time.</description>
    <arm_group_label>Body Scan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sitting practice</intervention_name>
    <description>In the sitting exercise, participants are guided to pay attention to a certain range of still points, starting with attention to breathing. In this exercise attention is fully concentrated on a single object: the sensation attached to breathing. If the mind wanders or is distracted by an external stimulus, attention is gently returned to sensations derived from breathing.</description>
    <arm_group_label>Sitting Practice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sign of informed consent&#xD;
&#xD;
          -  no previous meditation training experience&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental or neurologic disorder&#xD;
&#xD;
          -  respiratory disease&#xD;
&#xD;
          -  previous brain damage history&#xD;
&#xD;
          -  medication intake that could interfere in the electroencephalographic results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier García Campayo, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aragon Health Sciences Institute (IACS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arrabal Health Center</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://webmindfulness.com</url>
    <description>Description of the research &amp; teaching activities on mindfulness of REDIAPP research network</description>
  </link>
  <reference>
    <citation>Soler J, Cebolla A, Feliu-Soler A, Demarzo MM, Pascual JC, Banos R, Garcia-Campayo J. Relationship between meditative practice and self-reported mindfulness: the MINDSENS composite index. PLoS One. 2014 Jan 22;9(1):e86622. doi: 10.1371/journal.pone.0086622. eCollection 2014.</citation>
    <PMID>24466175</PMID>
  </reference>
  <reference>
    <citation>Fayed N, Lopez Del Hoyo Y, Andres E, Serrano-Blanco A, Bellon J, Aguilar K, Cebolla A, Garcia-Campayo J. Brain changes in long-term zen meditators using proton magnetic resonance spectroscopy and diffusion tensor imaging: a controlled study. PLoS One. 2013;8(3):e58476. doi: 10.1371/journal.pone.0058476. Epub 2013 Mar 25.</citation>
    <PMID>23536796</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Miguel Servet</investigator_affiliation>
    <investigator_full_name>Javier Garcia Campayo</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>mindfulness meditation</keyword>
  <keyword>alpha rhythm</keyword>
  <keyword>EEG</keyword>
  <keyword>brain mapping</keyword>
  <keyword>emotion</keyword>
  <keyword>attention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT02191553
org study id: PI13/0129
nct id: NCT02191553
lead sponsor: 
has dmc: No
Mindfulness can be considered as a family of complex attentional and emotional regulation
      strategies that promote the cultivation of well-being and emotional balance. The practice of
      mindfulness produces the development of a consciousness that unfolds moment to moment, open
      and unprejudiced in the present moment, here and now. Despite its extensive benefits, the
      practice of mindfulness requires a significant commitment in time and effort, which limits
      the potential for its dissemination. The studies to narrow the differential effects of the
      various exercises based on mindfulness, will further enhance their effectiveness and they can
      guide the practice sequence according to user needs. In this paper we will research
      mindfulness electroencephalographic correlates of as four different exercise programs
      included in mindfulness-based cognitive therapy (MBCT) and stress reduction program based on
      mindfulness (MBSR) as well as its effect on several psychological variables.
Mindfulness is a way of using attention intentionally, repeatedly reactivating the
      attentional focus, so that it enhances the ability of sustained attention. It involves a
      complex process of self-regulation and inhibition of internal and external stimuli
      interferences.

      Although the overall effects of meditation on brain bioelectrical signals are still being
      characterized, there is some consensus on the fact that meditation helps alter brain activity
      in both state and trait.

      The specific aim of this study is to assess the differential effect of four different
      practices of mindfulness in psychological well-being and their corresponding
      neurophysiological correlates.

      The hypothesis is that different exercises within the range of mindfulness practices exert
      different effects in terms of electroencephalographic activity, expecting different band
      increases in alpha (activity 7-to 2 Hz), beta (activity more than 13 Hz), theta (activity 4-6
      Hz) and delta (activity less than 3 Hz) respectively, as well as changes in the
      lateralization of the activity (left or right hemisphere). We also expect an improvement in
      the variables such as mindfulness, self-compassion, positive affect, anxiety, depression and
      sleep quality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Different facets of Mindfulness
time frame: 3 months
description: The Five Facets Mindfulness Questionnaire (FFMQ) will be used: It assesses the following facets of mindfulness: Observing, describing, acting with awareness, non judging of inner experience and non-reactivity to inner experience
measure: Brain function
time frame: 3 months
description: We will use cerebral cartography
measure: Positive and negative affectivity
time frame: 3 months
description: It will be measured with PANAS questionnaire
measure: anxiety and depression
time frame: 3 months
description: Measured with Hospital Anxiety Depression Scale
measure: Insomnia
time frame: 3 months
description: Measured with Pittsburgh Sleep Quality Index (PSQI)
measure: Self-compassion
time frame: 3 months
description: Measured with Self-Compassion Scale
measure: heart function and heart variability rate
time frame: 3 months
description: The investigators will use electrocardiogram
arm group label: Control Group: Relaxation Techniques
arm group type: Active Comparator
description: Relaxation techniques which do not involve either formal or informal mindfulness training. Subjects in this group practice Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.
arm group label: Loving Kindness Meditation (Metta)
arm group type: Experimental
description: Loving-kindness meditation following Kristin Neff protocol
arm group label: Body Scan
arm group type: Experimental
description: Body scan as described in standard MBSR protocol
arm group label: Sitting Practice
arm group type: Experimental
description: Sitting practice as mindfulness meditation described in standard MBSR protocols.
intervention type: Behavioral
intervention name: Control group relaxation techniques
description: Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.
arm group label: Control Group: Relaxation Techniques
intervention type: Behavioral
intervention name: Loving-kindness meditation
description: Following Kristin Neff protocol
arm group label: Loving Kindness Meditation (Metta)
intervention type: Behavioral
intervention name: Body scan
description: Body scan: Attention being directed with detailed awareness to every part of the body for a sustained period of time.
arm group label: Body Scan
intervention type: Behavioral
intervention name: Sitting practice
description: In the sitting exercise, participants are guided to pay attention to a certain range of still points, starting with attention to breathing. In this exercise attention is fully concentrated on a single object: the sensation attached to breathing. If the mind wanders or is distracted by an external stimulus, attention is gently returned to sensations derived from breathing.
arm group label: Sitting Practice
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Javier García Campayo, Dr
role: Principal Investigator
affiliation: Aragon Health Sciences Institute (IACS)
facility: 
country: Spain
url: http://webmindfulness.com
description: Description of the research & teaching activities on mindfulness of REDIAPP research network
citation: Soler J, Cebolla A, Feliu-Soler A, Demarzo MM, Pascual JC, Banos R, Garcia-Campayo J. Relationship between meditative practice and self-reported mindfulness: the MINDSENS composite index. PLoS One. 2014 Jan 22;9(1):e86622. doi: 10.1371/journal.pone.0086622. eCollection 2014.
PMID: 24466175
citation: Fayed N, Lopez Del Hoyo Y, Andres E, Serrano-Blanco A, Bellon J, Aguilar K, Cebolla A, Garcia-Campayo J. Brain changes in long-term zen meditators using proton magnetic resonance spectroscopy and diffusion tensor imaging: a controlled study. PLoS One. 2013;8(3):e58476. doi: 10.1371/journal.pone.0058476. Epub 2013 Mar 25.
PMID: 23536796
responsible party type: Principal Investigator
investigator affiliation: Hospital Miguel Servet
investigator full name: Javier Garcia Campayo
investigator title: PhD
mesh term: Depression