xml: <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/NCT06000449</url>
    </required_header>
    <id_info>
      <org_study_id>OHSU IRB 24818</org_study_id>
      <nct_id>NCT06000449</nct_id>
    </id_info>
    <brief_title>Center M: Digital Health Innovation Pilot</brief_title>
    <official_title>Center M: Digital Health Innovation Pilot</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oregon Health and Science University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Oregon Health and Science 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>
        Center M is a digital health solution to Perinatal Depression (PD) which provides an&#xD;
        alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M&#xD;
        shifts treatment to a telehealth model, reduces the number of sessions, and transitions home&#xD;
        practice materials to a digital format. This study will include a clinical trial in which&#xD;
        participants will be randomized to the Center M treatment with smartphone app delivery of&#xD;
        homework compared to treatment as usual (TAU).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 15, 2024</start_date>
    <completion_date type="Anticipated">September 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 15, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Screening Rate</measure>
      <time_frame>6 weeks postpartum</time_frame>
      <description>Rates of PD screening in Center M and TAU groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PD Symptoms at baseline</measure>
      <time_frame>Initial screening pre-intervention</time_frame>
      <description>PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PD Symptoms post intervention</measure>
      <time_frame>Two weeks post intervention</time_frame>
      <description>PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PD Symptoms post intervention</measure>
      <time_frame>Four weeks post intervention</time_frame>
      <description>PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PD Symptoms postpartum</measure>
      <time_frame>Six weeks postpartum</time_frame>
      <description>PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Participant Satisfaction</measure>
      <time_frame>Six weeks postpartum</time_frame>
      <description>Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Perinatal Depression</condition>
    <arm_group>
      <arm_group_label>Center M</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This intervention will include digital PD screening as well as four weekly one-hour group telehealth Mindfulness Cognitive Behavioral Therapy sessions and digitally delivered home practice materials for skill building between online group sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Center M</intervention_name>
      <description>Digital mental health platform. Screening and prevention activities will be provided through the Center M platform, telehealth group mindfulness sessions, and digitally delivered home practice materials.</description>
      <arm_group_label>Center M</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment as Usual</intervention_name>
      <description>Paper screening and PD handout.</description>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Currently pregnant&#xD;
  &#xD;
            -  Age 18-50 years&#xD;
  &#xD;
            -  Fluent in English&#xD;
  &#xD;
            -  Available and able to attend online group scheduled meetings&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current or past enrollment in a mindfulness-based intervention group&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ellen Tilden, PhD, CNM, FACNM</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oregon Health and Science University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristen Mackiewicz Seghete, PhD</last_name>
      <phone>503-494-3029</phone>
      <email>mackiewi@ohsu.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
      <investigator_full_name>Ellen Tilden</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Maternal Mental Health</keyword>
    <keyword>Telehealth</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified data will be shared with IRB #17203 (MBCT-PD Feasibility) #19166 (The Roo Study on Mom and Baby Well-Being) #18579 (Prenatal Environment and Child Health), #19004 (Maternal Well-Being Study) or #20186 (Parents Engaging Infants Study or PENGuIN). This is included in the consent form. Data will be linked between studies using non-HIPAA based participant identification numbers. Any research staff transferring data will be included on all of the study IRB protocols.</ipd_description>
      <ipd_access_criteria>Data for specific participants who need to be linked across studies will be deidentified and transferred. Data is only accessible on an individual user basis by Principal Investigators. Any research staff transferring data will be included on all of the study IRB protocols.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000449
  org study id: OHSU IRB 24818
  nct id: NCT06000449
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Center M is a digital health solution to Perinatal Depression (PD) which provides an
        alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M
        shifts treatment to a telehealth model, reduces the number of sessions, and transitions home
        practice materials to a digital format. This study will include a clinical trial in which
        participants will be randomized to the Center M treatment with smartphone app delivery of
        homework compared to treatment as usual (TAU).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Screening Rate
  time frame: 6 weeks postpartum
  description: Rates of PD screening in Center M and TAU groups.
  measure: PD Symptoms at baseline
  time frame: Initial screening pre-intervention
  description: PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
  measure: PD Symptoms post intervention
  time frame: Two weeks post intervention
  description: PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
  measure: PD Symptoms post intervention
  time frame: Four weeks post intervention
  description: PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
  measure: PD Symptoms postpartum
  time frame: Six weeks postpartum
  description: PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
  measure: Participant Satisfaction
  time frame: Six weeks postpartum
  description: Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).
  arm group label: Center M
  arm group type: Experimental
  description: This intervention will include digital PD screening as well as four weekly one-hour group telehealth Mindfulness Cognitive Behavioral Therapy sessions and digitally delivered home practice materials for skill building between online group sessions.
  arm group label: Treatment as Usual (TAU)
  arm group type: Active Comparator
  description: This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout.
  intervention type: Behavioral
  intervention name: Center M
  description: Digital mental health platform. Screening and prevention activities will be provided through the Center M platform, telehealth group mindfulness sessions, and digitally delivered home practice materials.
  arm group label: Center M
  intervention type: Behavioral
  intervention name: Treatment as Usual
  description: Paper screening and PD handout.
  arm group label: Treatment as Usual (TAU)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ellen Tilden, PhD, CNM, FACNM
  role: Principal Investigator
  affiliation: Oregon Health and Science University
  last name: Kristen Mackiewicz Seghete, PhD
  phone: 503-494-3029
  email: mackiewi@ohsu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Oregon Health and Science University
  investigator full name: Ellen Tilden
  investigator title: Principal Investigator
  mesh term: Depression
  sharing ipd: Yes
  ipd description: Deidentified data will be shared with IRB #17203 (MBCT-PD Feasibility) #19166 (The Roo Study on Mom and Baby Well-Being) #18579 (Prenatal Environment and Child Health), #19004 (Maternal Well-Being Study) or #20186 (Parents Engaging Infants Study or PENGuIN). This is included in the consent form. Data will be linked between studies using non-HIPAA based participant identification numbers. Any research staff transferring data will be included on all of the study IRB protocols.
  ipd access criteria: Data for specific participants who need to be linked across studies will be deidentified and transferred. Data is only accessible on an individual user basis by Principal Investigators. Any research staff transferring data will be included on all of the study IRB protocols.