<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/NCT03026959</url>
  </required_header>
  <id_info>
    <org_study_id>083 16-17</org_study_id>
    <nct_id>NCT03026959</nct_id>
  </id_info>
  <brief_title>Mindfulness and Maternal Mental Health</brief_title>
  <official_title>The Role of Mindfulness Skills Training in Maternal Mental Health: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lakehead University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lakehead University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is preliminary empirical support for the use of mindfulness interventions during the&#xD;
      perinatal period; suggesting that mindfulness training may be an effective treatment approach&#xD;
      for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress,&#xD;
      and psychological distress during the postpartum period. To extend on these findings, the&#xD;
      purpose of this research is to evaluate the effectiveness of a brief mindfulness-based&#xD;
      program in protecting maternal mental health and well-being using a randomized controlled&#xD;
      trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on the results reported in the existing literature that show that formal&#xD;
      mindfulness-based practice is effective for improving mental health status and preventing&#xD;
      depressive symptom relapse, this research aims to evaluate the effectiveness of a brief&#xD;
      mindfulness-based program, offered during pregnancy, in reducing mothers' psychological&#xD;
      symptoms during pregnancy and the postpartum period. A brief program has the advantage being&#xD;
      more economical to facilitate compared to full-length programs and also requires a shorter&#xD;
      commitment from pregnant women, who are also attempting to manage multiple other new and&#xD;
      existing demands (e.g., obstetrics appointments, work).&#xD;
&#xD;
      As emerging research suggests that women are particularly vulnerable to increased depressive,&#xD;
      anxious, obsessive, compulsive, and hypomanic symptoms during the perinatal period these are&#xD;
      the main psychological symptoms that will be assessed. As well, perceived stress and&#xD;
      psychological resiliency will also be assessed for in order to examine changes in these&#xD;
      domains in relation to mindfulness engagement. Furthermore, as a reduction in maternal&#xD;
      psychological symptoms has been reported to have implications for mother-infant bond, the&#xD;
      mother's interpersonal functioning, and maternal quality of life, the investigators will also&#xD;
      assess to see if there are corresponding changes in these domains related to mindfulness&#xD;
      engagement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Edinburgh Postnatal Depression Scale</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety and Depression Scale - Anxiety Subscale</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Obsessive-Compulsive Inventory-Revised</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Altman Self-Rating Mania Scale</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Five Facet Mindfulness Questionnaire</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Resilience Scale</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum Bonding Questionnaire</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life Scale</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Mindfulness</condition>
  <arm_group>
    <arm_group_label>Mindfulness Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the mindfulness group will attend four weekly sessions that are each 1.5 hours in length. The sessions will follow the structure described by Short, Mazmanian, Ozen, &amp; Bédard (2015). The structure is designed to first enhance learners' foundation skills in mindfulness and progresses into teaching learners more advanced mindfulness skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social (control) Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to the social group will also attend four weekly sessions that are each 1.5 hours in length. Each session will have participants focus on a creative tasks while permitting task related discussion. In this way the format is designed to parallel the mindfulness group, where participants engage in a new activity each week and have an opportunity to discuss the activities with the group without engaging in any formal intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>The mindfulness intervention follows the structure described by Short, Mazmanian, Ozen, &amp; Bédard, (2015).</description>
    <arm_group_label>Mindfulness Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant, age 18 years and older, able and willing to attend the study site for the&#xD;
             four group sessions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of a current severe mental health condition or mental heath difficulties that&#xD;
             would be better addressed through another form of therapy, active major medical&#xD;
             illness including significant obstetric complications, inability to give informed&#xD;
             consent, inability to speak or understand English, at high risk for delivery before&#xD;
             reaching full term (38 weeks gestation), or previous completion of a structured&#xD;
             mindfulness-based program.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dwight Mazmanian, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lakehead University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lakehead University</name>
      <address>
        <city>Thunder Bay</city>
        <state>Ontario</state>
        <zip>P7B 5E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Bedard M, Felteau M, Marshall S, Cullen N, Gibbons C, Dubois S, Maxwell H, Mazmanian D, Weaver B, Rees L, Gainer R, Klein R, Moustgaard A. Mindfulness-based cognitive therapy reduces symptoms of depression in people with a traumatic brain injury: results from a randomized controlled trial. J Head Trauma Rehabil. 2014 Jul-Aug;29(4):E13-22. doi: 10.1097/HTR.0b013e3182a615a0.</citation>
    <PMID>24052092</PMID>
  </reference>
  <reference>
    <citation>Davey HL, Tough SC, Adair CE, Benzies KM. Risk factors for sub-clinical and major postpartum depression among a community cohort of Canadian women. Matern Child Health J. 2011 Oct;15(7):866-75. doi: 10.1007/s10995-008-0314-8. Epub 2008 Feb 7.</citation>
    <PMID>18256913</PMID>
  </reference>
  <reference>
    <citation>Helmes E, Ward BG. Mindfulness-based cognitive therapy for anxiety symptoms in older adults in residential care. Aging Ment Health. 2017 Mar;21(3):272-278. doi: 10.1080/13607863.2015.1111862. Epub 2015 Nov 13.</citation>
    <PMID>26565928</PMID>
  </reference>
  <reference>
    <citation>O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):3-12. doi: 10.1016/j.bpobgyn.2013.09.002. Epub 2013 Oct 7.</citation>
    <PMID>24140480</PMID>
  </reference>
  <reference>
    <citation>Pope CJ, Sharma V, Mazmanian D. Recognition, diagnosis and treatment of postpartum bipolar depression. Expert Rev Neurother. 2014 Jan;14(1):19-28. doi: 10.1586/14737175.2014.846219. Epub 2013 Nov 26.</citation>
    <PMID>24308278</PMID>
  </reference>
  <reference>
    <citation>Russell EJ, Fawcett JM, Mazmanian D. Risk of obsessive-compulsive disorder in pregnant and postpartum women: a meta-analysis. J Clin Psychiatry. 2013 Apr;74(4):377-85. doi: 10.4088/JCP.12r07917.</citation>
    <PMID>23656845</PMID>
  </reference>
  <reference>
    <citation>Short MM, Mazmanian D, Ozen LJ, Bédard M. Four days of mindfulness meditation training for graduate students: A pilot study examining effects on mindfulness, self-regulation, and executive function. J Contemplative Inq. 2015; 2(1). http://journal.contemplativeinquiry.org/index.php/joci/article/view/13</citation>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lakehead University</investigator_affiliation>
    <investigator_full_name>Dwight Mazmanian</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03026959
org study id: 083 16-17
nct id: NCT03026959
lead sponsor: 
has dmc: No
There is preliminary empirical support for the use of mindfulness interventions during the
      perinatal period; suggesting that mindfulness training may be an effective treatment approach
      for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress,
      and psychological distress during the postpartum period. To extend on these findings, the
      purpose of this research is to evaluate the effectiveness of a brief mindfulness-based
      program in protecting maternal mental health and well-being using a randomized controlled
      trial.
Based on the results reported in the existing literature that show that formal
      mindfulness-based practice is effective for improving mental health status and preventing
      depressive symptom relapse, this research aims to evaluate the effectiveness of a brief
      mindfulness-based program, offered during pregnancy, in reducing mothers' psychological
      symptoms during pregnancy and the postpartum period. A brief program has the advantage being
      more economical to facilitate compared to full-length programs and also requires a shorter
      commitment from pregnant women, who are also attempting to manage multiple other new and
      existing demands (e.g., obstetrics appointments, work).

      As emerging research suggests that women are particularly vulnerable to increased depressive,
      anxious, obsessive, compulsive, and hypomanic symptoms during the perinatal period these are
      the main psychological symptoms that will be assessed. As well, perceived stress and
      psychological resiliency will also be assessed for in order to examine changes in these
      domains in relation to mindfulness engagement. Furthermore, as a reduction in maternal
      psychological symptoms has been reported to have implications for mother-infant bond, the
      mother's interpersonal functioning, and maternal quality of life, the investigators will also
      assess to see if there are corresponding changes in these domains related to mindfulness
      engagement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Edinburgh Postnatal Depression Scale
time frame: 12 weeks postpartum
measure: Hospital Anxiety and Depression Scale - Anxiety Subscale
time frame: 12 weeks postpartum
measure: Obsessive-Compulsive Inventory-Revised
time frame: 12 weeks postpartum
measure: Altman Self-Rating Mania Scale
time frame: 12 weeks postpartum
measure: Five Facet Mindfulness Questionnaire
time frame: 12 weeks postpartum
measure: Perceived Stress Scale
time frame: 12 weeks postpartum
measure: Brief Resilience Scale
time frame: 12 weeks postpartum
measure: Postpartum Bonding Questionnaire
time frame: 12 weeks postpartum
measure: World Health Organization Quality of Life Scale
time frame: 12 weeks postpartum
measure: Multidimensional Scale of Perceived Social Support
time frame: 12 weeks postpartum
arm group label: Mindfulness Group
arm group type: Experimental
description: Participants assigned to the mindfulness group will attend four weekly sessions that are each 1.5 hours in length. The sessions will follow the structure described by Short, Mazmanian, Ozen, & Bédard (2015). The structure is designed to first enhance learners' foundation skills in mindfulness and progresses into teaching learners more advanced mindfulness skills.
arm group label: Social (control) Group
arm group type: No Intervention
description: Participants assigned to the social group will also attend four weekly sessions that are each 1.5 hours in length. Each session will have participants focus on a creative tasks while permitting task related discussion. In this way the format is designed to parallel the mindfulness group, where participants engage in a new activity each week and have an opportunity to discuss the activities with the group without engaging in any formal intervention.
intervention type: Behavioral
intervention name: Mindfulness
description: The mindfulness intervention follows the structure described by Short, Mazmanian, Ozen, & Bédard, (2015).
arm group label: Mindfulness Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dwight Mazmanian, Ph.D
role: Principal Investigator
affiliation: Lakehead University
facility: 
country: Canada
citation: Bedard M, Felteau M, Marshall S, Cullen N, Gibbons C, Dubois S, Maxwell H, Mazmanian D, Weaver B, Rees L, Gainer R, Klein R, Moustgaard A. Mindfulness-based cognitive therapy reduces symptoms of depression in people with a traumatic brain injury: results from a randomized controlled trial. J Head Trauma Rehabil. 2014 Jul-Aug;29(4):E13-22. doi: 10.1097/HTR.0b013e3182a615a0.
PMID: 24052092
citation: Davey HL, Tough SC, Adair CE, Benzies KM. Risk factors for sub-clinical and major postpartum depression among a community cohort of Canadian women. Matern Child Health J. 2011 Oct;15(7):866-75. doi: 10.1007/s10995-008-0314-8. Epub 2008 Feb 7.
PMID: 18256913
citation: Helmes E, Ward BG. Mindfulness-based cognitive therapy for anxiety symptoms in older adults in residential care. Aging Ment Health. 2017 Mar;21(3):272-278. doi: 10.1080/13607863.2015.1111862. Epub 2015 Nov 13.
PMID: 26565928
citation: O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):3-12. doi: 10.1016/j.bpobgyn.2013.09.002. Epub 2013 Oct 7.
PMID: 24140480
citation: Pope CJ, Sharma V, Mazmanian D. Recognition, diagnosis and treatment of postpartum bipolar depression. Expert Rev Neurother. 2014 Jan;14(1):19-28. doi: 10.1586/14737175.2014.846219. Epub 2013 Nov 26.
PMID: 24308278
citation: Russell EJ, Fawcett JM, Mazmanian D. Risk of obsessive-compulsive disorder in pregnant and postpartum women: a meta-analysis. J Clin Psychiatry. 2013 Apr;74(4):377-85. doi: 10.4088/JCP.12r07917.
PMID: 23656845
citation: Short MM, Mazmanian D, Ozen LJ, Bédard M. Four days of mindfulness meditation training for graduate students: A pilot study examining effects on mindfulness, self-regulation, and executive function. J Contemplative Inq. 2015; 2(1). http://journal.contemplativeinquiry.org/index.php/joci/article/view/13
responsible party type: Principal Investigator
investigator affiliation: Lakehead University
investigator full name: Dwight Mazmanian
investigator title: Professor
sharing ipd: No