<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/NCT03247491</url>
  </required_header>
  <id_info>
    <org_study_id>50/2014/04</org_study_id>
    <nct_id>NCT03247491</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Mindfulness and Compassion Intervention for Pregnant Women and Their Partners for the Prevention of Stress and Depression During Pregnancy and Breastfeeding</brief_title>
  <official_title>Effectiveness of a Mindfulness and Compassion Group Intervention Applied to Pregnant Women and Their Partners to Decrease Stress, Negative Affect and Depression During Pregnancy and Breastfeeding. Controlled and Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Javier Garcia Campayo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Nacional de Educación a Distancia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Miguel Servet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess a mindfulness and compassion group intervention for&#xD;
      pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of&#xD;
      stress, negative affect and depression in pregnancy and breastfeeding. This group&#xD;
      intervention will also be compared with a Treatment as usual (TAU) group consisting in a&#xD;
      childbirth education class taught by the Health Center midwife. The principal hypothesis is&#xD;
      that the mindfulness and compassion intervention will be more effective than TAU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to assess a mindfulness and compassion group intervention for&#xD;
      pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of&#xD;
      stress, negative affect and depression in pregnancy and breastfeeding.&#xD;
&#xD;
      There will be two groups:&#xD;
&#xD;
        1. A face to face mindfulness and compassion intervention for pregnant women in their&#xD;
           second trimester of pregnancy and their partners in group format (8 weeks) based in the&#xD;
           Mindfulness Based Childbirth and Parenting program from Nancy Bardacke. This group will&#xD;
           also receive in their third trimester of pregnancy the childbirth education classes&#xD;
           taught by midwives (6-8 weeks) that every pregnant woman normally attends to in the&#xD;
           National Health Care System in Spain (TAU).&#xD;
&#xD;
        2. A control group that will receive only the childbirth education class by midwives (TAU)&#xD;
           group consisting in a childbirth education class taught by the Health Center midwife at&#xD;
           the third trimester of pregnancy.&#xD;
&#xD;
      Each group will be composed of 60 participants with a total sample of 120. The principal&#xD;
      hypothesis is that the mindfulness and compassion intervention will be more effective than&#xD;
      TAU in the decrease of stress, negative affect and depression and in the increase of positive&#xD;
      affect during pregnancy and breastfeeding.&#xD;
&#xD;
      The differences between the intervention and control group will be analyzed. Finally, a&#xD;
      qualitative study will be conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 2, 2019</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Edinburgh postnatal depression scale (EPDS)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the mindfulness and compassion based intervention group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Edinburgh postnatal depression scale (EPDS)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the TAU control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Edinburgh postnatal depression scale (EPDS)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in intervention group</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Edinburgh postnatal depression scale (EPDS)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in TAU control group</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Edinburgh postnatal depression scale (EPDS)</measure>
    <time_frame>Post-partum 3 months follow up in 8 weeks intervention group</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Edinburgh postnatal depression scale (EPDS)</measure>
    <time_frame>Post-partum 3 months follow up in TAU control group</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Edinburgh postnatal depression scale (EPDS)</measure>
    <time_frame>Post-partum 6 months follow up in 8 weeks intervention group</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Edinburgh postnatal depression scale (EPDS)</measure>
    <time_frame>Post-partum 6 months follow up in TAU control group</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic data Gender, age, marital status, education, occupation, economical level</measure>
    <time_frame>Baseline</time_frame>
    <description>In the mindfulness-based intervention applied face-to-face and TAU control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>M.I.N.I. International Neuropsychiatric Interview</measure>
    <time_frame>baseline applied in TAU and in intervention group</time_frame>
    <description>only if needed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client service receipt inventory (CSRI)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the mindfulness-based intervention applied face-to-face and TAU control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client service receipt inventory (CSRI)</measure>
    <time_frame>Post-partum 6 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client service receipt inventory (CSRI)</measure>
    <time_frame>Post-partum 6 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical data regarding delivery and breastfeeding</measure>
    <time_frame>2 months after delivery</time_frame>
    <description>In the mindfulness-based intervention applied face-to-face and TAU control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the mindfulness and compassion based intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the TAU control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Post-partum 3 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Post-partum 3 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Post-partum 6 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Post-partum 6 weeks follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect (PANAS)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the mindfulness and compassion based intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect (PANAS)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the TAU control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect (PANAS)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect (PANAS)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect (PANAS)</measure>
    <time_frame>Post-partum 3 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect (PANAS)</measure>
    <time_frame>Post-partum 3 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect (PANAS)</measure>
    <time_frame>Post-partum 6 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect (PANAS)</measure>
    <time_frame>Post-partum 6 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facets and factors of mindfulness (FFMQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the mindfulness and compassion based intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facets and factors of mindfulness (FFMQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the TAU control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facets and factors of mindfulness (FFMQ)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facets and factors of mindfulness (FFMQ)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facets and factors of mindfulness (FFMQ)</measure>
    <time_frame>Post-partum 3 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facets and factors of mindfulness (FFMQ)</measure>
    <time_frame>Post-partum 3 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facets and factors of mindfulness (FFMQ)</measure>
    <time_frame>Post-partum 6 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facets and factors of mindfulness (FFMQ)</measure>
    <time_frame>Post-partum 6 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale (SCS)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the mindfulness and compassion based intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale (SCS)</measure>
    <time_frame>Baseline</time_frame>
    <description>In the TAU control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale (SCS)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in 8 weeks intervention group</time_frame>
    <description>In the mindfulness and compassion based intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale (SCS)</measure>
    <time_frame>Post-treatment 8 weeks from baseline in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale (SCS)</measure>
    <time_frame>Post-partum 3 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale (SCS)</measure>
    <time_frame>Post-partum 3 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale (SCS)</measure>
    <time_frame>Post-partum 6 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale(SCS)</measure>
    <time_frame>Post-partum 6 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Evaluation Scale (EEP)</measure>
    <time_frame>Post-partum 3 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Evaluation Scale (EEP)</measure>
    <time_frame>Post-partum 3 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Evaluation Scale (EEP)</measure>
    <time_frame>Post-partum 6 months follow up in 8 weeks intervention group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Evaluation Scale (EEP)</measure>
    <time_frame>Post-partum 6 months follow up in TAU control group</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Pregnancy, Childbirth and Postpartum</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years old&#xD;
&#xD;
          -  Willingness to participate in the study and signing informed consent&#xD;
&#xD;
          -  Ability to understand and write Spanish.&#xD;
&#xD;
          -  Women will be in their 6 to 25 weeks of pregnancy.&#xD;
&#xD;
          -  All women eligible will be accepted with our without their partner.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any diagnose of disease that may affect central nervous system (brain pathology,&#xD;
             traumatic brain injury, dementia, etc.),&#xD;
&#xD;
          -  Other psychiatric diagnoses or acute psychiatric illness (substance dependence or&#xD;
             abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.),&#xD;
&#xD;
          -  Any medical, infectious or degenerative disease that may affect mood, presence of&#xD;
             delusional ideas or hallucinations consistent or not with mood, and suicide risk&#xD;
&#xD;
          -  Currently taking psychopharmacological medication or under psychopharmacological&#xD;
             treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad Nacional de Educacion a Distancia</name>
      <address>
        <city>Valladolid</city>
        <zip>47013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202. doi: 10.1007/s10826-009-9313-7. Epub 2009 Oct 10.</citation>
    <PMID>20339571</PMID>
  </reference>
  <reference>
    <citation>Duncan, L.G., Cohn, M.A., Chao, M.T., Cook, J.G., Riccobono, J., &amp; Bardacke, N. (2014a) Mind in labor: Effects of mind/body training on childbirth appraisals and pain medication use during labor. The Journal of Alternative and Complementary Medicine, 20, A17-A17.</citation>
  </reference>
  <reference>
    <citation>Duncan, L.G., Cohn, M.A., Cook, J.G., Hecht, F.M., &amp; Bardacke, N. (2014b) The mind in labor: Employing mindfulness to alleviate fear and pain in childbirth. Poster presented at the 2nd biennial International Symposium for Contemplative Studies. Boston, MA.</citation>
  </reference>
  <reference>
    <citation>Duncan LG, Shaddix C. Mindfulness-Based Childbirth and Parenting (MBCP): Innovation in Birth Preparation to Support Healthy, Happy Families. Int J Birth Parent Educ. 2015 Jan;2(2):30-33. No abstract available.</citation>
    <PMID>29051821</PMID>
  </reference>
  <reference>
    <citation>Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.</citation>
    <PMID>28499376</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>December 1, 2019</last_update_submitted>
  <last_update_submitted_qc>December 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Miguel Servet</investigator_affiliation>
    <investigator_full_name>Javier Garcia Campayo</investigator_full_name>
    <investigator_title>Co-director of Olga Sacristán´s (principal investigator) ph dissertation</investigator_title>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>Compassion</keyword>
  <keyword>Depression during Pregnancy and Postpartum</keyword>
  <keyword>Prevention</keyword>
  <keyword>Stress</keyword>
  <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/NCT03247491
org study id: 50/2014/04
nct id: NCT03247491
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess a mindfulness and compassion group intervention for
      pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of
      stress, negative affect and depression in pregnancy and breastfeeding. This group
      intervention will also be compared with a Treatment as usual (TAU) group consisting in a
      childbirth education class taught by the Health Center midwife. The principal hypothesis is
      that the mindfulness and compassion intervention will be more effective than TAU.
The aim of this study is to assess a mindfulness and compassion group intervention for
      pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of
      stress, negative affect and depression in pregnancy and breastfeeding.

      There will be two groups:

        1. A face to face mindfulness and compassion intervention for pregnant women in their
           second trimester of pregnancy and their partners in group format (8 weeks) based in the
           Mindfulness Based Childbirth and Parenting program from Nancy Bardacke. This group will
           also receive in their third trimester of pregnancy the childbirth education classes
           taught by midwives (6-8 weeks) that every pregnant woman normally attends to in the
           National Health Care System in Spain (TAU).

        2. A control group that will receive only the childbirth education class by midwives (TAU)
           group consisting in a childbirth education class taught by the Health Center midwife at
           the third trimester of pregnancy.

      Each group will be composed of 60 participants with a total sample of 120. The principal
      hypothesis is that the mindfulness and compassion intervention will be more effective than
      TAU in the decrease of stress, negative affect and depression and in the increase of positive
      affect during pregnancy and breastfeeding.

      The differences between the intervention and control group will be analyzed. Finally, a
      qualitative study will be conducted.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Edinburgh postnatal depression scale (EPDS)
time frame: Baseline
description: In the mindfulness and compassion based intervention group
measure: Edinburgh postnatal depression scale (EPDS)
time frame: Baseline
description: In the TAU control group
measure: Edinburgh postnatal depression scale (EPDS)
time frame: Post-treatment 8 weeks from baseline in intervention group
measure: Edinburgh postnatal depression scale (EPDS)
time frame: Post-treatment 8 weeks from baseline in TAU control group
measure: Edinburgh postnatal depression scale (EPDS)
time frame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Edinburgh postnatal depression scale (EPDS)
time frame: Post-partum 3 months follow up in TAU control group
measure: Edinburgh postnatal depression scale (EPDS)
time frame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Edinburgh postnatal depression scale (EPDS)
time frame: Post-partum 6 months follow up in TAU control group
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
time frame: Baseline
description: In the mindfulness-based intervention applied face-to-face and TAU control group
measure: M.I.N.I. International Neuropsychiatric Interview
time frame: baseline applied in TAU and in intervention group
description: only if needed
measure: Client service receipt inventory (CSRI)
time frame: Baseline
description: In the mindfulness-based intervention applied face-to-face and TAU control group
measure: Client service receipt inventory (CSRI)
time frame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Client service receipt inventory (CSRI)
time frame: Post-partum 6 months follow up in TAU control group
measure: Medical data regarding delivery and breastfeeding
time frame: 2 months after delivery
description: In the mindfulness-based intervention applied face-to-face and TAU control group
measure: Perceived Stress Scale (PSS)
time frame: Baseline
description: In the mindfulness and compassion based intervention group
measure: Perceived Stress Scale (PSS)
time frame: Baseline
description: In the TAU control group
measure: Perceived Stress Scale (PSS)
time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Perceived Stress Scale (PSS)
time frame: Post-treatment 8 weeks from baseline in TAU control group
measure: Perceived Stress Scale (PSS)
time frame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Perceived Stress Scale (PSS)
time frame: Post-partum 3 months follow up in TAU control group
measure: Perceived Stress Scale (PSS)
time frame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Perceived Stress Scale (PSS)
time frame: Post-partum 6 weeks follow up in TAU control group
measure: Positive and negative affect (PANAS)
time frame: Baseline
description: In the mindfulness and compassion based intervention group
measure: Positive and negative affect (PANAS)
time frame: Baseline
description: In the TAU control group
measure: Positive and negative affect (PANAS)
time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Positive and negative affect (PANAS)
time frame: Post-treatment 8 weeks from baseline in TAU control group
measure: Positive and negative affect (PANAS)
time frame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Positive and negative affect (PANAS)
time frame: Post-partum 3 months follow up in TAU control group
measure: Positive and negative affect (PANAS)
time frame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Positive and negative affect (PANAS)
time frame: Post-partum 6 months follow up in TAU control group
measure: Five Facets and factors of mindfulness (FFMQ)
time frame: Baseline
description: In the mindfulness and compassion based intervention group
measure: Five Facets and factors of mindfulness (FFMQ)
time frame: Baseline
description: In the TAU control group
measure: Five Facets and factors of mindfulness (FFMQ)
time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Five Facets and factors of mindfulness (FFMQ)
time frame: Post-treatment 8 weeks from baseline in TAU control group
measure: Five Facets and factors of mindfulness (FFMQ)
time frame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Five Facets and factors of mindfulness (FFMQ)
time frame: Post-partum 3 months follow up in TAU control group
measure: Five Facets and factors of mindfulness (FFMQ)
time frame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Five Facets and factors of mindfulness (FFMQ)
time frame: Post-partum 6 months follow up in TAU control group
measure: Self Compassion Scale (SCS)
time frame: Baseline
description: In the mindfulness and compassion based intervention group
measure: Self Compassion Scale (SCS)
time frame: Baseline
description: In the TAU control group
measure: Self Compassion Scale (SCS)
time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
description: In the mindfulness and compassion based intervention group
measure: Self Compassion Scale (SCS)
time frame: Post-treatment 8 weeks from baseline in TAU control group
measure: Self Compassion Scale (SCS)
time frame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Self Compassion Scale (SCS)
time frame: Post-partum 3 months follow up in TAU control group
measure: Self Compassion Scale (SCS)
time frame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Self Compassion Scale(SCS)
time frame: Post-partum 6 months follow up in TAU control group
measure: Parental Evaluation Scale (EEP)
time frame: Post-partum 3 months follow up in 8 weeks intervention group
measure: Parental Evaluation Scale (EEP)
time frame: Post-partum 3 months follow up in TAU control group
measure: Parental Evaluation Scale (EEP)
time frame: Post-partum 6 months follow up in 8 weeks intervention group
measure: Parental Evaluation Scale (EEP)
time frame: Post-partum 6 months follow up in TAU control group
arm group label: Experimental
arm group type: Experimental
description: TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
arm group label: No intervention
arm group type: No Intervention
description: Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy).
intervention type: Behavioral
intervention name: Mindfulness
description: TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
arm group label: Experimental
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
citation: Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202. doi: 10.1007/s10826-009-9313-7. Epub 2009 Oct 10.
PMID: 20339571
citation: Duncan, L.G., Cohn, M.A., Chao, M.T., Cook, J.G., Riccobono, J., & Bardacke, N. (2014a) Mind in labor: Effects of mind/body training on childbirth appraisals and pain medication use during labor. The Journal of Alternative and Complementary Medicine, 20, A17-A17.
citation: Duncan, L.G., Cohn, M.A., Cook, J.G., Hecht, F.M., & Bardacke, N. (2014b) The mind in labor: Employing mindfulness to alleviate fear and pain in childbirth. Poster presented at the 2nd biennial International Symposium for Contemplative Studies. Boston, MA.
citation: Duncan LG, Shaddix C. Mindfulness-Based Childbirth and Parenting (MBCP): Innovation in Birth Preparation to Support Healthy, Happy Families. Int J Birth Parent Educ. 2015 Jan;2(2):30-33. No abstract available.
PMID: 29051821
citation: Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.
PMID: 28499376
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Miguel Servet
investigator full name: Javier Garcia Campayo
investigator title: Co-director of Olga Sacristán´s (principal investigator) ph dissertation
mesh term: Depression
sharing ipd: No