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Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study (MORPHE)

Primary Purpose

Postpartum Psychiatric Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Digital Mindfulness Training
Sponsored by
Nina Ayala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Psychiatric Disorders focused on measuring dispositional optimism, mindfulness, adverse perinatal outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Able to provide informed consent English speaking Nulliparous (no prior delivery at or greater than 20w0d gestation) Pregnant with singleton fetus <20w0d gestation Low dispositional optimism (score </= 14 on the Revised Life Orientation Test) Owns a smart phone Exclusion Criteria: Plan to deliver at another institution Ongoing (≥1/week) mind-body practice including mindfulness training, meditation or yoga Pre-gestational hypertensive disorder Pre-gestational diabetes mellitus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    App-based mindfulness training

    Usual Care

    Arm Description

    App-based daily mindfulness training Standard prenatal and pregnancy care

    Standard prenatal and pregnancy care

    Outcomes

    Primary Outcome Measures

    Percentage of participants completing the assigned mindfulness exercises
    The intervention will be considered feasible if ≥75% participants complete >50% of the assigned daily mindfulness exercises over the 8-week intervention period
    Intervention acceptability
    The intervention will be considered acceptable if ≥75% report "satisfied" or "very satisfied" on a post-intervention consumer satisfaction survey with a 5-point Likert scale from very unsatisfied to very satisfied.

    Secondary Outcome Measures

    Dispositional optimism
    Change in dispositional optimism score (on validated Revised Life Orientation Test, scale range 0-24, higher scores indicate higher optimism) between enrollment and postpartum assessments
    Cesarean delivery
    Binary yes/no
    Hypertensive disorder of pregnancy
    Binary yes/no; includes gestational hypertension, pre-eclampsia with or without severe features, HELLP syndrome or eclampsia
    Gestational diabetes mellitus
    Binary yes/no
    Preterm birth
    Binary yes/no; Delivery between 20w0d and 36w6d gestation
    Traumatic birth
    Binary yes/no; Self-reported experience of birth as traumatic given concern for life or well-being of self or infant
    Postpartum post-traumatic stress symptoms
    Continuous scale score using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5, scale range 0-80, higher scores indicate worse post-traumatic stress symptoms)

    Full Information

    First Posted
    April 17, 2023
    Last Updated
    April 28, 2023
    Sponsor
    Nina Ayala
    Collaborators
    The Miriam Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05840900
    Brief Title
    Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study
    Acronym
    MORPHE
    Official Title
    Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2025 (Anticipated)
    Study Completion Date
    March 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nina Ayala
    Collaborators
    The Miriam Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Dispositional optimism is malleable, although prior interventions have been time and resource intensive and thus are not well-tailored to the peripartum period. The purpose of this pilot study is to evaluate the feasibility and acceptability of a pregnancy-oriented mindfulness phone application (Expectful) versus standard care among first-time mothers with low dispositional optimism in early pregnancy. Other aims include evaluating the impact of Expectful use on dispositional optimism, adverse pregnancy outcomes (cesarean delivery, hypertensive disorders of pregnancy, and gestational diabetes) and postpartum post-traumatic stress symptoms.
    Detailed Description
    This randomized clinical trial of nulliparous women with low dispositional optimism in early pregnancy seeks to determine whether use of a pregnancy-oriented digital mindfulness application will be feasible and acceptable and show preliminary evidence of efficacy in improving dispositional optimism, reducing adverse perinatal outcomes and improving postpartum post-traumatic stress symptoms. This pilot will include 100 women recruited from the obstetrical service at Women and Infants Hospital of Rhode Island. Women will be included if they are nulliparous, have a singleton pregnancy at <20 weeks gestational age, speak English and have low dispositional optimism (a score of ≤14 on the validated, Revised Life Orientation Test). Eligible participants will be randomized to either using the digital app Expectful or standard pregnancy care. Women will be randomized with equal probability to the intervention group using block randomization stratified by race/ethnicity (Hispanic, non-Hispanic White/Other or non-Hispanic Black). Women in the mindfulness training arm will complete 8 weeks of daily mindfulness training exercises using Expectful. Women in the standard care group will receive standard pregnancy and postpartum care. Pregnancy and labor management will be at the discretion of each participant's obstetric provider. Participants in both groups will be asked to complete 4 questionnaires: one at enrollment, a post-intervention one at 8 weeks, at the time of delivery and at 6-8 weeks postpartum. Half of the participants in each arm (total n=50), will be asked to complete a qualitative, semi-structured interview on the role of optimism and other resilience factors in pregnancy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Psychiatric Disorders
    Keywords
    dispositional optimism, mindfulness, adverse perinatal outcomes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Participants and clinicians will not be blinded, but the outcomes assessor and analytic teams will be blinded to participant allocation.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    App-based mindfulness training
    Arm Type
    Experimental
    Arm Description
    App-based daily mindfulness training Standard prenatal and pregnancy care
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Standard prenatal and pregnancy care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Digital Mindfulness Training
    Intervention Description
    Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful
    Primary Outcome Measure Information:
    Title
    Percentage of participants completing the assigned mindfulness exercises
    Description
    The intervention will be considered feasible if ≥75% participants complete >50% of the assigned daily mindfulness exercises over the 8-week intervention period
    Time Frame
    8-week intervention period
    Title
    Intervention acceptability
    Description
    The intervention will be considered acceptable if ≥75% report "satisfied" or "very satisfied" on a post-intervention consumer satisfaction survey with a 5-point Likert scale from very unsatisfied to very satisfied.
    Time Frame
    After 8 week intervention period, approximately 16-28 weeks gestation.
    Secondary Outcome Measure Information:
    Title
    Dispositional optimism
    Description
    Change in dispositional optimism score (on validated Revised Life Orientation Test, scale range 0-24, higher scores indicate higher optimism) between enrollment and postpartum assessments
    Time Frame
    Study enrollment and 6-12 weeks postpartum
    Title
    Cesarean delivery
    Description
    Binary yes/no
    Time Frame
    Delivery
    Title
    Hypertensive disorder of pregnancy
    Description
    Binary yes/no; includes gestational hypertension, pre-eclampsia with or without severe features, HELLP syndrome or eclampsia
    Time Frame
    6-12 weeks postpartum
    Title
    Gestational diabetes mellitus
    Description
    Binary yes/no
    Time Frame
    Delivery
    Title
    Preterm birth
    Description
    Binary yes/no; Delivery between 20w0d and 36w6d gestation
    Time Frame
    Delivery
    Title
    Traumatic birth
    Description
    Binary yes/no; Self-reported experience of birth as traumatic given concern for life or well-being of self or infant
    Time Frame
    Delivery
    Title
    Postpartum post-traumatic stress symptoms
    Description
    Continuous scale score using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5, scale range 0-80, higher scores indicate worse post-traumatic stress symptoms)
    Time Frame
    6-12 weeks postpartum

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to provide informed consent English speaking Nulliparous (no prior delivery at or greater than 20w0d gestation) Pregnant with singleton fetus <20w0d gestation Low dispositional optimism (score </= 14 on the Revised Life Orientation Test) Owns a smart phone Exclusion Criteria: Plan to deliver at another institution Ongoing (≥1/week) mind-body practice including mindfulness training, meditation or yoga Pre-gestational hypertensive disorder Pre-gestational diabetes mellitus
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nina K Ayala, MD, MSCR
    Phone
    401-274-1100
    Ext
    43435
    Email
    nayala@carene.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emily S Miller, MD, MPH
    Phone
    401-274-1100
    Ext
    47452
    Email
    emmiller@carene.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study

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