<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/NCT02214732</url>
  </required_header>
  <id_info>
    <org_study_id>REB13-0860</org_study_id>
    <nct_id>NCT02214732</nct_id>
  </id_info>
  <brief_title>Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy</brief_title>
  <official_title>A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Centre for Child, Family &amp; Community Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alberta Family Wellness Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anxiety, stress and depression are common during pregnancy and in the postpartum period. The&#xD;
      lack of empirically supported, non-pharmaceutical interventions for psychological distress in&#xD;
      pregnancy is a significant gap in the literature, especially given many pregnant women's&#xD;
      preference for non-pharmaceutical treatments. This study will evaluate the efficacy of&#xD;
      Mindfulness Based Cognitive Therapy (MBCT) program in reducing measures of psychological&#xD;
      distress (e.g., symptoms of stress, depression and anxiety) in a group of pregnant women&#xD;
      endorsing high levels of distress.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum</measure>
    <time_frame>Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby)</time_frame>
    <description>Symptoms of depression will be assessed using the 10-item, self-report Edinburgh Postpartum Depression Scale (EPDS). The EPDS has been validated against interview schedules and other self-report instruments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment</measure>
    <time_frame>Baseline (Week 1), Post-Treatment (Week 10)</time_frame>
    <description>The Pregnancy Anxiety Measure, a 10-item instrument will be used to examine the extent to which women are worried about their own and baby's health, labour, delivery and caring their new baby.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months</measure>
    <time_frame>Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum</time_frame>
    <description>This questionnaire will be used in assessing the perception of stress. The questions are in regards to participant's feelings and thoughts during the previous month. It was designed to be used in community samples. The items are assessing perceived helplessness and self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 3 months</measure>
    <time_frame>Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum</time_frame>
    <description>The PSQI instrument will be used in assessing participant's sleep quality. There are seven components of the PSQI and these are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months</measure>
    <time_frame>Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum</time_frame>
    <description>Actigraphy monitoring provides objective information on circadian rhythm amplitude, acrophase, as well as indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings. The use of actigraphy has been demonstrated sensitive to treatment effects, while being less costly and intrusive than polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in salivary cortisol profile from baseline to 3 months</measure>
    <time_frame>Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum</time_frame>
    <description>All samples are assayed for salivary cortisol using a highly sensitive enzyme immunoassay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in measures of blood pressure (BP) from baseline to 3 months</measure>
    <time_frame>Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum</time_frame>
    <description>BP data will be collected using an automatic, calibrated, oscillometric BP monitor and a BP cuff on the upper part of the dominant arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in measures of heart rate variability from baseline to 3 months</measure>
    <time_frame>Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum</time_frame>
    <description>Measures of heart rate (bpm) will be recorded noninvasively using a HIC-2000 Bio-electric Impedance Cardiograph and the Cardiac Output Program, developed by Bio-Impedance Technology.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>MBCT + Treatment as Usual (TAU)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioural: Mindfulness Based Cognitive Therapy&#xD;
Participants in the MBCT group attend an 8 week course of a modified MBCT program for pregnant women, delivered by a licensed clinical psychologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the TAU group access community resources for pregnant women experiencing psychological distress.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Based Cognitive Therapy</intervention_name>
    <description>The modified MBCT program for pregnant women is an 8-session group intervention that aims to help women change their relationship to the thoughts, feelings, and bodily sensations that can lead to psychological distress. Participants are guided to recognize and disengage from unhelpful mind states characterized by self-perpetuating patterns of ruminative thought. The intervention was modified to address pregnant women's physical and emotional needs, as well as their risk of perinatal mood episodes.</description>
    <arm_group_label>MBCT + Treatment as Usual (TAU)</arm_group_label>
    <other_name>MBCT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible women for this study&#xD;
&#xD;
          -  are between 12 and 28 weeks of gestation,&#xD;
&#xD;
          -  are experiencing psychological distress (elevated perinatal anxiety, mild depressive&#xD;
             symptoms, or high-levels of self-reported stress)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current suicidality&#xD;
&#xD;
          -  current substance abuse or dependence&#xD;
&#xD;
          -  experience a current major depressive episode&#xD;
&#xD;
          -  have been diagnosed with bipolar disorder or other disorders that have a psychotic,&#xD;
             dissociative, hallucinatory, or delusional component&#xD;
&#xD;
          -  taking prescribed medications that affect sleep or mood&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lianne Tomfohr-Madsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Riley Park Maternity Clinic</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>September 13, 2018</last_update_submitted>
  <last_update_submitted_qc>September 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Lianne Tomfohr-Madsen</investigator_full_name>
    <investigator_title>Assistant Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Postpartum</keyword>
  <keyword>Mindfulness Based Cognitive Therapy</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Stress</keyword>
  <keyword>MBCT</keyword>
  <keyword>Actigraphy</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/NCT02214732
org study id: REB13-0860
nct id: NCT02214732
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Anxiety, stress and depression are common during pregnancy and in the postpartum period. The
      lack of empirically supported, non-pharmaceutical interventions for psychological distress in
      pregnancy is a significant gap in the literature, especially given many pregnant women's
      preference for non-pharmaceutical treatments. This study will evaluate the efficacy of
      Mindfulness Based Cognitive Therapy (MBCT) program in reducing measures of psychological
      distress (e.g., symptoms of stress, depression and anxiety) in a group of pregnant women
      endorsing high levels of distress.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby)
description: Symptoms of depression will be assessed using the 10-item, self-report Edinburgh Postpartum Depression Scale (EPDS). The EPDS has been validated against interview schedules and other self-report instruments.
measure: Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment
time frame: Baseline (Week 1), Post-Treatment (Week 10)
description: The Pregnancy Anxiety Measure, a 10-item instrument will be used to examine the extent to which women are worried about their own and baby's health, labour, delivery and caring their new baby.
measure: Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
description: This questionnaire will be used in assessing the perception of stress. The questions are in regards to participant's feelings and thoughts during the previous month. It was designed to be used in community samples. The items are assessing perceived helplessness and self-efficacy.
measure: Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
description: The PSQI instrument will be used in assessing participant's sleep quality. There are seven components of the PSQI and these are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction.
measure: Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
description: Actigraphy monitoring provides objective information on circadian rhythm amplitude, acrophase, as well as indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings. The use of actigraphy has been demonstrated sensitive to treatment effects, while being less costly and intrusive than polysomnography.
measure: Change in salivary cortisol profile from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
description: All samples are assayed for salivary cortisol using a highly sensitive enzyme immunoassay.
measure: Change in measures of blood pressure (BP) from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
description: BP data will be collected using an automatic, calibrated, oscillometric BP monitor and a BP cuff on the upper part of the dominant arm.
measure: Changes in measures of heart rate variability from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
description: Measures of heart rate (bpm) will be recorded noninvasively using a HIC-2000 Bio-electric Impedance Cardiograph and the Cardiac Output Program, developed by Bio-Impedance Technology.
arm group label: MBCT + Treatment as Usual (TAU)
arm group type: Experimental
description: Behavioural: Mindfulness Based Cognitive Therapy
Participants in the MBCT group attend an 8 week course of a modified MBCT program for pregnant women, delivered by a licensed clinical psychologist.
arm group label: Treatment as Usual (TAU)
arm group type: No Intervention
description: Participants in the TAU group access community resources for pregnant women experiencing psychological distress.
intervention type: Behavioral
intervention name: Mindfulness Based Cognitive Therapy
description: The modified MBCT program for pregnant women is an 8-session group intervention that aims to help women change their relationship to the thoughts, feelings, and bodily sensations that can lead to psychological distress. Participants are guided to recognize and disengage from unhelpful mind states characterized by self-perpetuating patterns of ruminative thought. The intervention was modified to address pregnant women's physical and emotional needs, as well as their risk of perinatal mood episodes.
arm group label: MBCT + Treatment as Usual (TAU)
other name: MBCT
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lianne Tomfohr-Madsen, PhD
role: Principal Investigator
affiliation: University of Calgary
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Lianne Tomfohr-Madsen
investigator title: Assistant Professor of Psychology
mesh term: Depression