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Center M: Digital Health Innovation Pilot

Primary Purpose

Perinatal Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Center M
Treatment as Usual
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Depression focused on measuring Maternal Mental Health, Telehealth

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Currently pregnant Age 18-50 years Fluent in English Available and able to attend online group scheduled meetings Exclusion Criteria: Current or past enrollment in a mindfulness-based intervention group

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Center M

    Treatment as Usual (TAU)

    Arm 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.

    This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout.

    Outcomes

    Primary Outcome Measures

    Screening Rate
    Rates of PD screening in Center M and TAU groups.
    PD Symptoms at baseline
    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).
    PD Symptoms post intervention
    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).
    PD Symptoms post intervention
    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).
    PD Symptoms postpartum
    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).

    Secondary Outcome Measures

    Participant Satisfaction
    Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).

    Full Information

    First Posted
    August 14, 2023
    Last Updated
    August 14, 2023
    Sponsor
    Oregon Health and Science University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06000449
    Brief Title
    Center M: Digital Health Innovation Pilot
    Official Title
    Center M: Digital Health Innovation Pilot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2024 (Anticipated)
    Primary Completion Date
    July 15, 2024 (Anticipated)
    Study Completion Date
    September 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oregon Health and Science University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perinatal Depression
    Keywords
    Maternal Mental Health, Telehealth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Center M
    Arm Type
    Experimental
    Arm 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 Title
    Treatment as Usual (TAU)
    Arm Type
    Active Comparator
    Arm 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(s)
    Center M
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as Usual
    Intervention Description
    Paper screening and PD handout.
    Primary Outcome Measure Information:
    Title
    Screening Rate
    Description
    Rates of PD screening in Center M and TAU groups.
    Time Frame
    6 weeks postpartum
    Title
    PD Symptoms at baseline
    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).
    Time Frame
    Initial screening pre-intervention
    Title
    PD Symptoms 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).
    Time Frame
    Two weeks post intervention
    Title
    PD Symptoms 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).
    Time Frame
    Four weeks post intervention
    Title
    PD Symptoms 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).
    Time Frame
    Six weeks postpartum
    Secondary Outcome Measure Information:
    Title
    Participant Satisfaction
    Description
    Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).
    Time Frame
    Six weeks postpartum

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Currently pregnant Age 18-50 years Fluent in English Available and able to attend online group scheduled meetings Exclusion Criteria: Current or past enrollment in a mindfulness-based intervention group
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristen Mackiewicz Seghete, PhD
    Phone
    503-494-3029
    Email
    mackiewi@ohsu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ellen Tilden, PhD, CNM, FACNM
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan 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 Sharing 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.

    Learn more about this trial

    Center M: Digital Health Innovation Pilot

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