<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/NCT03285139</url>
  </required_header>
  <id_info>
    <org_study_id>PL CBT</org_study_id>
    <nct_id>NCT03285139</nct_id>
  </id_info>
  <brief_title>Peer Administered CBT for PPD</brief_title>
  <acronym>PL-CBT</acronym>
  <official_title>Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kids Can Fly Brantford</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 up to 20% of women and has profound effects on mothers&#xD;
      and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based&#xD;
      care. This is at least partly due to significant difficulties faced by women in accessing&#xD;
      cognitive behavioural therapy (CBT), a preferred 1st line treatment. In Ontario at present,&#xD;
      there is a significant lack of personnel trained to deliver CBT. This study will utilize a&#xD;
      randomized controlled trial design (with wait list controls) and recruit 70 participants to&#xD;
      determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver&#xD;
      effective group CBT to women with current PPD. If peers can be trained to provide effective&#xD;
      CBT, more women would receive treatment and the burden of PPD on women, families, and the&#xD;
      healthcare system would be significantly reduced.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers&#xD;
      and their infants. Indeed, the cost of one case of PPD is estimated to exceed $150,000.&#xD;
      Unfortunately, fewer than 15% of women with PPD receive evidence-based care and this is at&#xD;
      least partly due to difficulties accessing treatment, particularly those that are most&#xD;
      preferred (e.g., psychotherapy).&#xD;
&#xD;
      Clinical practice guidelines recommend that the majority of women with PPD receive&#xD;
      psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment and that&#xD;
      screening only occur in settings where CBT is readily available. In order to increase access&#xD;
      to treatment, screening efforts have been undertaken by public health units province-wide.&#xD;
      This is despite recommendations that this only be conducted in the setting of timely access&#xD;
      to evidence-based psychotherapies (e.g., CBT). The purpose of this study is to apply task&#xD;
      shifting to the treatment of PPD by determining if women with a past history of PPD (i.e.,&#xD;
      lay peers) living in the community can be trained to deliver effective group CBT to women&#xD;
      with current PPD.&#xD;
&#xD;
      A group CBT intervention for PPD has been developed and validated as well as a training&#xD;
      program that pilot data suggests is capable of successfully training public health nurses&#xD;
      with little background psychiatric training. This intervention is brief, effective, and&#xD;
      generalizable to women with PPD in community. Peer administered interventions (PAIs), those&#xD;
      delivered by recovered former patients are increasingly recognized as potentially effective&#xD;
      alternatives to traditional mental health care services. Eight lay peers will be trained to&#xD;
      deliver our 9-week group CBT treatment. 74 women will be recruited and using a randomized&#xD;
      controlled trial design (with wait list controls), it will be determined if lay peers can&#xD;
      deliver effective group CBT for PPD.&#xD;
&#xD;
      If peers can be trained to provide effective CBT, more women would receive treatment and the&#xD;
      burden of PPD on women, families, and the healthcare system would be significantly reduced.&#xD;
      Providing women with PPD with CBT skills at this crucial stage in life also has the capacity&#xD;
      to prevent future depressive relapse with significant benefits for patients, families,&#xD;
      employers, and the healthcare system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</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</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>
  <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>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>CCHS Maternal Healthcare Utilization</measure>
    <time_frame>6 months</time_frame>
    <description>Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult Adolescent Parenting Inventory</measure>
    <time_frame>6 months</time_frame>
    <description>Used to assess the parenting and child rearing attitudes of parents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Therapy Awareness Scale</measure>
    <time_frame>6 months</time_frame>
    <description>Used to assess CBT skill and knowledge and fidelity to the CBT model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapist Evaluation Checklist</measure>
    <time_frame>6 months</time_frame>
    <description>Used to assess the quality of CBT practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>6 months</time_frame>
    <description>Used to measure health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder-7</measure>
    <time_frame>6 months</time_frame>
    <description>Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini International Neuropsychiatric Interview - Current Major Depressive Disorder</measure>
    <time_frame>6 months</time_frame>
    <description>Used to asses maternal depression.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>Immediate Intervention</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 Cognitive Behavioural Therapy intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton and 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. The CBT intervention will be delivered by lay-peers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group CBT for PPD 9 weeks after enrollment. The women in this arm of the study will receive the same Cognitive Behavioural Therapy intervention as in the immediate intervention arm, however they will begin the CBT group 9 weeks after enrolling in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment. The participants in this arm of the study will not be suffering from postpartum depression and will not receive the Cognitive Behavioural Therapy treatment. Healthy controls will complete study measures upon enrollment in the study, 9 weeks later as well as 6 months later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioural Therapy</intervention_name>
    <description>Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.</description>
    <arm_group_label>Immediate Intervention</arm_group_label>
    <arm_group_label>Wait List Controls</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 commodities 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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Van Lieshout, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kids Can Fly</name>
      <address>
        <city>Brantford</city>
        <state>Ontario</state>
        <zip>N3L 3E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 22, 2022</last_update_submitted>
  <last_update_submitted_qc>March 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</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>CBT</keyword>
  <keyword>Lay Peer</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/NCT03285139
org study id: PL CBT
nct id: NCT03285139
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers
      and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based
      care. This is at least partly due to significant difficulties faced by women in accessing
      cognitive behavioural therapy (CBT), a preferred 1st line treatment. In Ontario at present,
      there is a significant lack of personnel trained to deliver CBT. This study will utilize a
      randomized controlled trial design (with wait list controls) and recruit 70 participants to
      determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver
      effective group CBT to women with current PPD. If peers can be trained to provide effective
      CBT, more women would receive treatment and the burden of PPD on women, families, and the
      healthcare system would be significantly reduced.
Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers
      and their infants. Indeed, the cost of one case of PPD is estimated to exceed $150,000.
      Unfortunately, fewer than 15% of women with PPD receive evidence-based care and this is at
      least partly due to difficulties accessing treatment, particularly those that are most
      preferred (e.g., psychotherapy).

      Clinical practice guidelines recommend that the majority of women with PPD receive
      psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment and that
      screening only occur in settings where CBT is readily available. In order to increase access
      to treatment, screening efforts have been undertaken by public health units province-wide.
      This is despite recommendations that this only be conducted in the setting of timely access
      to evidence-based psychotherapies (e.g., CBT). The purpose of this study is to apply task
      shifting to the treatment of PPD by determining if women with a past history of PPD (i.e.,
      lay peers) living in the community can be trained to deliver effective group CBT to women
      with current PPD.

      A group CBT intervention for PPD has been developed and validated as well as a training
      program that pilot data suggests is capable of successfully training public health nurses
      with little background psychiatric training. This intervention is brief, effective, and
      generalizable to women with PPD in community. Peer administered interventions (PAIs), those
      delivered by recovered former patients are increasingly recognized as potentially effective
      alternatives to traditional mental health care services. Eight lay peers will be trained to
      deliver our 9-week group CBT treatment. 74 women will be recruited and using a randomized
      controlled trial design (with wait list controls), it will be determined if lay peers can
      deliver effective group CBT for PPD.

      If peers can be trained to provide effective CBT, more women would receive treatment and the
      burden of PPD on women, families, and the healthcare system would be significantly reduced.
      Providing women with PPD with CBT skills at this crucial stage in life also has the capacity
      to prevent future depressive relapse with significant benefits for patients, families,
      employers, and the healthcare system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Edinburgh Postnatal Depression Scale
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: Postpartum Bonding Questionnaire
time frame: 6 months
description: Used to detect disorders of the mother-infant relationship.
measure: Social Provisions Scale
time frame: 6 months
description: Used to measure the degree to which mothers' social relationships provide support.
measure: CCHS Maternal Healthcare Utilization
time frame: 6 months
description: Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.
measure: Adult Adolescent Parenting Inventory
time frame: 6 months
description: Used to assess the parenting and child rearing attitudes of parents.
measure: Cognitive Therapy Awareness Scale
time frame: 6 months
description: Used to assess CBT skill and knowledge and fidelity to the CBT model.
measure: Therapist Evaluation Checklist
time frame: 6 months
description: Used to assess the quality of CBT practice.
measure: EQ-5D
time frame: 6 months
description: Used to measure health-related quality of life.
measure: Generalized Anxiety Disorder-7
time frame: 6 months
description: Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.
measure: Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
time frame: 6 months
description: Used to asses maternal depression.
arm group label: Immediate Intervention
arm group type: Experimental
description: Group CBT for PPD. Women in the treatment group will attend a 9-week group Cognitive Behavioural Therapy intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton and 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. The CBT intervention will be delivered by lay-peers.
arm group label: Wait List Controls
arm group type: Experimental
description: Group CBT for PPD 9 weeks after enrollment. The women in this arm of the study will receive the same Cognitive Behavioural Therapy intervention as in the immediate intervention arm, however they will begin the CBT group 9 weeks after enrolling in the study.
arm group label: Healthy Controls
arm group type: No Intervention
description: No treatment. The participants in this arm of the study will not be suffering from postpartum depression and will not receive the Cognitive Behavioural Therapy treatment. Healthy controls will complete study measures upon enrollment in the study, 9 weeks later as well as 6 months later.
intervention type: Behavioral
intervention name: Cognitive Behavioural Therapy
description: Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.
arm group label: Immediate Intervention
arm group label: Wait List Controls
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ryan Van Lieshout, MD, PhD
role: Principal Investigator
affiliation: McMaster University
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