<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/NCT03039530</url>
  </required_header>
  <id_info>
    <org_study_id>PH CBT</org_study_id>
    <nct_id>NCT03039530</nct_id>
  </id_info>
  <brief_title>Group CBT for PPD in the Public Health Setting</brief_title>
  <official_title>Impact of Public Health Nurse Delivered Group CBT for Postpartum Depression on Women and Their Children: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Niagara Region Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</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>
      Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have&#xD;
      profound effects on mothers, their children, and their families. The cost of one case of PPD&#xD;
      exceeds $150,000, a significant proportion of which is related to its impact on offspring.&#xD;
      However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer&#xD;
      than 15% of women receiving care. While Public Health Units have played an important role in&#xD;
      PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver&#xD;
      evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group&#xD;
      format is effective for treating depression in the perinatal period, and as PHNs are often&#xD;
      the first point of contact for women experiencing PPD, with specialized training it is likely&#xD;
      that they can deliver high-quality CBT.&#xD;
&#xD;
      The primary objective of this study is to determine if PHNs can be trained to deliver group&#xD;
      Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence,&#xD;
      improve mother-infant attachment and parenting and optimize infant emotional functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In addition to its effects on maternal health, PPD can adversely affect mother-infant&#xD;
      attachment, parenting, and the development and health of her children. The negative effects&#xD;
      of PPD on offspring can include an increased risk of insecure attachment, poorer cognitive,&#xD;
      language, and behavioral development, as well as an increased risk of emotion regulatory&#xD;
      problems. To determine if PHNs can effectively deliver group CBT for PPD that is superior to&#xD;
      postnatal care as usual, the investigators will proceed with a randomized controlled trial&#xD;
      (RCT). Women in the treatment group will attend a 9-week group CBT intervention delivered by&#xD;
      trained PHNs. Those in the control group will receive standard postnatal care.&#xD;
&#xD;
      This RCT will compare the effects of group CBT to postnatal care as usual on maternal&#xD;
      depression, anxiety, mother-infant attachment, parenting, healthcare utilization and social&#xD;
      support, as well as infant development, emotion regulation, and healthcare utilization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</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>Edinburgh Postnatal Depression Scale (EPDS)</measure>
    <time_frame>6 months</time_frame>
    <description>The EPDS will be used to assess maternal depression. A score of &gt;12 is consistent with PPD and changes in scores &gt;4 are indicative of clinically significant improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini International Neuropsychiatric Interview - Current Major Depressive Disorder</measure>
    <time_frame>6 months</time_frame>
    <description>Used to assess maternal depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Penn State Worry Questionnaire (PSWQ)</measure>
    <time_frame>6 months</time_frame>
    <description>Maternal Anxiety will be assessed using the Penn State Worry Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum Bonding Questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Used to detect disorders of the mother-infant relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-Child Early Relational Assessment</measure>
    <time_frame>6 months</time_frame>
    <description>Used to measure the quality of affect and behavior in parent-child interactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Provisions Scale</measure>
    <time_frame>6 months</time_frame>
    <description>Used to measure the degree to which mothers' social relationships provide support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ages and Stages Questionnaires - Third Edition</measure>
    <time_frame>6 months</time_frame>
    <description>Assesses infant communication, motor and socioemotional development using age-specific scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal &amp; Infant Healthcare Utilization</measure>
    <time_frame>6 months</time_frame>
    <description>Adopted form the Canadian Community Health Survey to track use of healthcare services.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Behaviour Questionnaire-Revised</measure>
    <time_frame>6 months</time_frame>
    <description>This scale assesses infant temperament</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Face-to-Face Still Face Paradigm</measure>
    <time_frame>6 months</time_frame>
    <description>Experimental task used to assess emotion regulation in infants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parasympathetic Nervous System Functioning: Heart Rate Variability</measure>
    <time_frame>6 months</time_frame>
    <description>Used to asses the flexibility of the central and peripheral nervous system to handle stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary Cortisol</measure>
    <time_frame>6 months</time_frame>
    <description>Used to assess stress reactivity and emotion regulation. Three samples will be taken during each assessment: 10-15 minutes after the beginning of the assessment, 15-20 minutes after the face-to-face still face task and at the end of the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)</measure>
    <time_frame>6 months</time_frame>
    <description>Corticolimbic brain activity at the scalp will be assessed using electroencephalography (EEG). Greater left frontal asymmetry (greater activity in the left frontal hemisphere) is thought to reflect positive emotionality and indicate a greater tendency to engage in more adaptive emotion regulation strategies. However greater right activity reflects a tendency to engage in withdrawn behaviours and negative emotionality.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Depression, Postpartum</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group CBT for PPD. Women in the treatment group will attend a 9-week group CBT intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Care. The usual care group will receive standard care from their family physician and midwife or obstetrician. They will also be made aware of the perinatal programming available to them through Niagara Region Public Health. Women and family physicians will also receive a copy of the Canadian Practice Guidelines for the Treatment of Perinatal Depression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Cognitive Behavioral Therapy</intervention_name>
    <description>9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Postnatal Care As Usual</intervention_name>
    <description>Postnatal care as usual will involve treatment from their family physician and midwife or obstetrician, and voluntary participation in programs offered by Niagara Region Public Health and in the community.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible women will be &gt;18 years of age, understand and speak English (so that they&#xD;
             can participate in the CBT group and complete study measures), have an EPDS score&#xD;
             between 10 and 23. They will also all be within 12 months of delivering an infant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women can have psychiatric comorbidities with the exception of bipolar disorder, a&#xD;
             current psychotic, substance or alcohol use disorder, or antisocial or borderline&#xD;
             personality disorder.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Niagara Region Public Health</name>
      <address>
        <city>Thorold</city>
        <state>Ontario</state>
        <zip>L2V 4Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Ryan Van Lieshout, MD, PhD</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Psychiatry and Behavioural Neurosciences</investigator_title>
  </responsible_party>
  <keyword>Postpartum Depression</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Public Health</keyword>
  <keyword>Mother</keyword>
  <keyword>Infant</keyword>
  <keyword>Emotion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT03039530
org study id: PH CBT
nct id: NCT03039530
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have
      profound effects on mothers, their children, and their families. The cost of one case of PPD
      exceeds $150,000, a significant proportion of which is related to its impact on offspring.
      However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer
      than 15% of women receiving care. While Public Health Units have played an important role in
      PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver
      evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group
      format is effective for treating depression in the perinatal period, and as PHNs are often
      the first point of contact for women experiencing PPD, with specialized training it is likely
      that they can deliver high-quality CBT.

      The primary objective of this study is to determine if PHNs can be trained to deliver group
      Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence,
      improve mother-infant attachment and parenting and optimize infant emotional functioning.
In addition to its effects on maternal health, PPD can adversely affect mother-infant
      attachment, parenting, and the development and health of her children. The negative effects
      of PPD on offspring can include an increased risk of insecure attachment, poorer cognitive,
      language, and behavioral development, as well as an increased risk of emotion regulatory
      problems. To determine if PHNs can effectively deliver group CBT for PPD that is superior to
      postnatal care as usual, the investigators will proceed with a randomized controlled trial
      (RCT). Women in the treatment group will attend a 9-week group CBT intervention delivered by
      trained PHNs. Those in the control group will receive standard postnatal care.

      This RCT will compare the effects of group CBT to postnatal care as usual on maternal
      depression, anxiety, mother-infant attachment, parenting, healthcare utilization and social
      support, as well as infant development, emotion regulation, and healthcare utilization
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Edinburgh Postnatal Depression Scale (EPDS)
time frame: 6 months
description: The EPDS will be used to assess maternal depression. A score of >12 is consistent with PPD and changes in scores >4 are indicative of clinically significant improvement.
measure: Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
time frame: 6 months
description: Used to assess maternal depression.
measure: Penn State Worry Questionnaire (PSWQ)
time frame: 6 months
description: Maternal Anxiety will be assessed using the Penn State Worry Questionnaire.
measure: Postpartum Bonding Questionnaire
time frame: 6 months
description: Used to detect disorders of the mother-infant relationship.
measure: Parent-Child Early Relational Assessment
time frame: 6 months
description: Used to measure the quality of affect and behavior in parent-child interactions.
measure: Social Provisions Scale
time frame: 6 months
description: Used to measure the degree to which mothers' social relationships provide support
measure: Ages and Stages Questionnaires - Third Edition
time frame: 6 months
description: Assesses infant communication, motor and socioemotional development using age-specific scales.
measure: Maternal & Infant Healthcare Utilization
time frame: 6 months
description: Adopted form the Canadian Community Health Survey to track use of healthcare services.
measure: Infant Behaviour Questionnaire-Revised
time frame: 6 months
description: This scale assesses infant temperament
measure: Face-to-Face Still Face Paradigm
time frame: 6 months
description: Experimental task used to assess emotion regulation in infants
measure: Parasympathetic Nervous System Functioning: Heart Rate Variability
time frame: 6 months
description: Used to asses the flexibility of the central and peripheral nervous system to handle stress.
measure: Salivary Cortisol
time frame: 6 months
description: Used to assess stress reactivity and emotion regulation. Three samples will be taken during each assessment: 10-15 minutes after the beginning of the assessment, 15-20 minutes after the face-to-face still face task and at the end of the visit.
measure: Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)
time frame: 6 months
description: Corticolimbic brain activity at the scalp will be assessed using electroencephalography (EEG). Greater left frontal asymmetry (greater activity in the left frontal hemisphere) is thought to reflect positive emotionality and indicate a greater tendency to engage in more adaptive emotion regulation strategies. However greater right activity reflects a tendency to engage in withdrawn behaviours and negative emotionality.
arm group label: Treatment Group
arm group type: Experimental
description: Group CBT for PPD. Women in the treatment group will attend a 9-week group CBT intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.
arm group label: Control Group
arm group type: Active Comparator
description: Standard Care. The usual care group will receive standard care from their family physician and midwife or obstetrician. They will also be made aware of the perinatal programming available to them through Niagara Region Public Health. Women and family physicians will also receive a copy of the Canadian Practice Guidelines for the Treatment of Perinatal Depression.
intervention type: Behavioral
intervention name: Group Cognitive Behavioral Therapy
description: 9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.
arm group label: Treatment Group
intervention type: Behavioral
intervention name: Postnatal Care As Usual
description: Postnatal care as usual will involve treatment from their family physician and midwife or obstetrician, and voluntary participation in programs offered by Niagara Region Public Health and in the community.
arm group label: Control Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Ryan Van Lieshout, MD, PhD
investigator title: Assistant Professor, Department of Psychiatry and Behavioural Neurosciences
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder