<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/NCT03291600</url>
  </required_header>
  <id_info>
    <org_study_id>20170061B</org_study_id>
    <nct_id>NCT03291600</nct_id>
  </id_info>
  <brief_title>Virtual Psychiatric Care for Perinatal Depression</brief_title>
  <acronym>Virtual-PND</acronym>
  <official_title>Virtual Psychiatric Care for Perinatal Depression (Virtual-PND): A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Women's College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sinai Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Women's College Hospital</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>
      Perinatal depression occurs in 15% of pregnant women and new mothers, yet as few as 1 in 5&#xD;
      receive adequate treatment. It has a negative impact on the woman herself, as well as a&#xD;
      potential for serious consequences for her child. Virtual psychiatric care is a potential&#xD;
      model that may provide accessible mental health care during this time, as barriers to&#xD;
      in-person care often include unpredictable infant schedules, competing childcare demands, or&#xD;
      travel/cost challenges. The Virtual-PND intervention consists of 12-weeks of the option of&#xD;
      supplementing in-person psychiatric care with secure, in-home real-time video-visits through&#xD;
      the Ontario Telemedicine Network. This pilot RCT will demonstrate the feasibility of&#xD;
      proceeding to a future large-scale RCT evaluation of virtual psychiatric care for this&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-site pilot randomized controlled trial (RCT) to evaluate the feasibility of a&#xD;
      Virtual Psychiatric Care for Perinatal Depression (Virtual-PND) intervention protocol,&#xD;
      comparing virtual care to in-person care only. Participants will be pregnant or postpartum&#xD;
      women with a major depressive disorder who are referred for care at one of the participating&#xD;
      study sites. Each study site is a specialist reproductive psychiatric program where women&#xD;
      from the greater Toronto area are referred, and generally treated with in-person care. Those&#xD;
      randomized to the virtual care group will be able to receive psychiatric visits with&#xD;
      video-based visits. Those randomized to the in-person care group will receive in-person care&#xD;
      only, as per usual clinical practice at the study sites. The length of the active treatment&#xD;
      phase will be 12 weeks from enrolment. The overall objective of this pilot RCT is to&#xD;
      determine the feasibility of conducting a larger RCT to evaluate the efficacy of the&#xD;
      treatment model, comparing outcomes among those with and without access to virtual care, and&#xD;
      cost-effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>
    <intervention_model_description>Behavioral: Virtual Psychiatric Care for Perinatal Depression</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment Feasibility (Recruitment Feasibility)</measure>
    <time_frame>One year from when the study starts enrolling participants</time_frame>
    <description>The number of women recruited to the study at each site</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depressive Scale (EPDS)</measure>
    <time_frame>At 12 weeks post-randomization</time_frame>
    <description>The investigators will measure depressive symptoms using the EPDS, a self-report, 10-item depression screening measure that has been validated for use in pregnancy. EPDS scores &gt;12 are predictive of a diagnosis of major depressive disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>At 12 weeks post-randomization</time_frame>
    <description>The investigators will measure anxious symptoms using the STAI, a self-report, 40-item anxiety screening measure that has shown good discriminate validity in perinatal populations. STAI scores &gt;48 are predictive of having an anxiety disorder diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Stress Index, Short Form (PSI)</measure>
    <time_frame>At 12 weeks post-randomization</time_frame>
    <description>The investigators will measure stress in the parent-child relationship using the PSI short form, a 36-item measure which consists of three sub-scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment Feasibility (Recruitment Eligibility)</measure>
    <time_frame>One year from when the study starts enrolling participants</time_frame>
    <description>The proportion of participants eligible to participate at each recruitment site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment Feasibility (Enrollment)</measure>
    <time_frame>From enrollment to first treatment visit</time_frame>
    <description>Average length of time from enrollment to 1st psychiatrist visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Acceptability (Qualitative - participants)</measure>
    <time_frame>At 12 weeks post-randomization</time_frame>
    <description>Virtual-PND Participant Program Evaluation Questionnaire. This is comprised of Likert-type scale questions to elicit feedback on acceptability of the virtual care experience and model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Acceptability (Qualitative - physicians)</measure>
    <time_frame>At 12 weeks post-randomization</time_frame>
    <description>Virtual-PND Physician Program Evaluation Questionnaire. This is comprised of open and closed-ended questions to elicit feedback on the acceptability of the virtual care experience and model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Acceptability (Patient-Reported Costs)</measure>
    <time_frame>At 12 weeks post-randomization</time_frame>
    <description>Patient-Reported Costs Questionnaire. This is comprised of open and closed-ended questions regarding: a) time spent travelling to visits and on missed work; and b) cost of travel, food, childcare and data charges.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Acceptability (Clinical visits)</measure>
    <time_frame>Between randomization and 12 weeks post-randomization</time_frame>
    <description>Medical chart review - number of psychiatrist visits (overall, in person, and virtual), and number of minutes per visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trial Protocol Adherence (Study Measure Completion)</measure>
    <time_frame>At 12 weeks post-randomization</time_frame>
    <description>Proportion of participants who complete follow-up measures.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Perinatal Depression</condition>
  <arm_group>
    <arm_group_label>Virtual Psychiatric Care Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the intervention group will have the option to receive video-based psychiatrist care in addition to care as usual. Participants will be assigned to begin immediately after randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women allocated to the control condition will receive care as usual (in-person psychiatric care) from the study site to which they were referred.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Psychiatric Care</intervention_name>
    <description>Virtual psychiatric care for perinatal depression will be offered to participants, in addition to care as usual, for a 12-week period by their treating perinatal psychiatrist. Virtual care will be delivered by video-based visits through the Ontario Telemedicine Network (OTN). The treating psychiatrist may request that an intervention group participant present for in-person care at any visit, and this may include need for behavioural activation, or another health-related indication at the discretion of the treating psychiatrist.</description>
    <arm_group_label>Virtual Psychiatric Care Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  Pregnant or 0-12 months postpartum&#xD;
&#xD;
          -  Experiencing clinically significant depressive symptoms (defined as a score of ≥12 on&#xD;
             the Edinburgh Postnatal Depressive Scale, EPDS, during eligibility screening)&#xD;
&#xD;
          -  Able to access the internet on a device (i.e. mobile phone, tablet, personal computer)&#xD;
             with video-visit capacity (including web camera and speakers)&#xD;
&#xD;
          -  Comfortable with email communication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active alcohol/substance use disorder in the past 12 months&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
&#xD;
          -  Current mania or psychosis&#xD;
&#xD;
          -  Unsuitable for virtual care, as per assessment of the treating psychiatrist&#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>Lori Wasserman, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women's College Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ariel Dalfen, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sinai Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's College Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 1B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asphyxia Neonatorum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT03291600
org study id: 20170061B
nct id: NCT03291600
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perinatal depression occurs in 15% of pregnant women and new mothers, yet as few as 1 in 5
      receive adequate treatment. It has a negative impact on the woman herself, as well as a
      potential for serious consequences for her child. Virtual psychiatric care is a potential
      model that may provide accessible mental health care during this time, as barriers to
      in-person care often include unpredictable infant schedules, competing childcare demands, or
      travel/cost challenges. The Virtual-PND intervention consists of 12-weeks of the option of
      supplementing in-person psychiatric care with secure, in-home real-time video-visits through
      the Ontario Telemedicine Network. This pilot RCT will demonstrate the feasibility of
      proceeding to a future large-scale RCT evaluation of virtual psychiatric care for this
      population.
This is a two-site pilot randomized controlled trial (RCT) to evaluate the feasibility of a
      Virtual Psychiatric Care for Perinatal Depression (Virtual-PND) intervention protocol,
      comparing virtual care to in-person care only. Participants will be pregnant or postpartum
      women with a major depressive disorder who are referred for care at one of the participating
      study sites. Each study site is a specialist reproductive psychiatric program where women
      from the greater Toronto area are referred, and generally treated with in-person care. Those
      randomized to the virtual care group will be able to receive psychiatric visits with
      video-based visits. Those randomized to the in-person care group will receive in-person care
      only, as per usual clinical practice at the study sites. The length of the active treatment
      phase will be 12 weeks from enrolment. The overall objective of this pilot RCT is to
      determine the feasibility of conducting a larger RCT to evaluate the efficacy of the
      treatment model, comparing outcomes among those with and without access to virtual care, and
      cost-effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Behavioral: Virtual Psychiatric Care for Perinatal Depression
primary purpose: Treatment
masking: None (Open Label)
measure: Recruitment Feasibility (Recruitment Feasibility)
time frame: One year from when the study starts enrolling participants
description: The number of women recruited to the study at each site
measure: Edinburgh Postnatal Depressive Scale (EPDS)
time frame: At 12 weeks post-randomization
description: The investigators will measure depressive symptoms using the EPDS, a self-report, 10-item depression screening measure that has been validated for use in pregnancy. EPDS scores >12 are predictive of a diagnosis of major depressive disorder.
measure: State-Trait Anxiety Inventory (STAI)
time frame: At 12 weeks post-randomization
description: The investigators will measure anxious symptoms using the STAI, a self-report, 40-item anxiety screening measure that has shown good discriminate validity in perinatal populations. STAI scores >48 are predictive of having an anxiety disorder diagnosis.
measure: Parenting Stress Index, Short Form (PSI)
time frame: At 12 weeks post-randomization
description: The investigators will measure stress in the parent-child relationship using the PSI short form, a 36-item measure which consists of three sub-scales.
measure: Recruitment Feasibility (Recruitment Eligibility)
time frame: One year from when the study starts enrolling participants
description: The proportion of participants eligible to participate at each recruitment site
measure: Recruitment Feasibility (Enrollment)
time frame: From enrollment to first treatment visit
description: Average length of time from enrollment to 1st psychiatrist visit
measure: Intervention Acceptability (Qualitative - participants)
time frame: At 12 weeks post-randomization
description: Virtual-PND Participant Program Evaluation Questionnaire. This is comprised of Likert-type scale questions to elicit feedback on acceptability of the virtual care experience and model.
measure: Intervention Acceptability (Qualitative - physicians)
time frame: At 12 weeks post-randomization
description: Virtual-PND Physician Program Evaluation Questionnaire. This is comprised of open and closed-ended questions to elicit feedback on the acceptability of the virtual care experience and model.
measure: Intervention Acceptability (Patient-Reported Costs)
time frame: At 12 weeks post-randomization
description: Patient-Reported Costs Questionnaire. This is comprised of open and closed-ended questions regarding: a) time spent travelling to visits and on missed work; and b) cost of travel, food, childcare and data charges.
measure: Intervention Acceptability (Clinical visits)
time frame: Between randomization and 12 weeks post-randomization
description: Medical chart review - number of psychiatrist visits (overall, in person, and virtual), and number of minutes per visit.
measure: Trial Protocol Adherence (Study Measure Completion)
time frame: At 12 weeks post-randomization
description: Proportion of participants who complete follow-up measures.
arm group label: Virtual Psychiatric Care Group
arm group type: Experimental
description: Participants randomized to the intervention group will have the option to receive video-based psychiatrist care in addition to care as usual. Participants will be assigned to begin immediately after randomization.
arm group label: Control Group
arm group type: No Intervention
description: Women allocated to the control condition will receive care as usual (in-person psychiatric care) from the study site to which they were referred.
intervention type: Behavioral
intervention name: Virtual Psychiatric Care
description: Virtual psychiatric care for perinatal depression will be offered to participants, in addition to care as usual, for a 12-week period by their treating perinatal psychiatrist. Virtual care will be delivered by video-based visits through the Ontario Telemedicine Network (OTN). The treating psychiatrist may request that an intervention group participant present for in-person care at any visit, and this may include need for behavioural activation, or another health-related indication at the discretion of the treating psychiatrist.
arm group label: Virtual Psychiatric Care Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lori Wasserman, MD, FRCPC
role: Principal Investigator
affiliation: Women's College Hospital
last name: Ariel Dalfen, MD, FRCPC
role: Principal Investigator
affiliation: Sinai Health System
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Asphyxia Neonatorum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No