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NCT Number: NCT05840900

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

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.

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Key information

Conditions

Postpartum Psychiatric Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetrics and Gynecology Care Center, Providence, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Mindfulness Training

Behavioral

Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful

Primary outcomes

  1. Percentage of participants completing the assigned mindfulness exercises

    Time frame: 8-week intervention period

    The intervention will be considered feasible if ≥75% participants complete >50% of the assigned daily mindfulness exercises over the 8-week intervention period

  2. Intervention acceptability

    Time frame: After 8 week intervention period, approximately 16-28 weeks gestation.

    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 outcomes

  1. Dispositional optimism

    Time frame: Study enrollment and 6-12 weeks postpartum

    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

  2. Cesarean delivery

    Time frame: Delivery

    Binary yes/no

  3. Hypertensive disorder of pregnancy

    Time frame: 6-12 weeks postpartum

    Binary yes/no; includes gestational hypertension, pre-eclampsia with or without severe features, HELLP syndrome or eclampsia

  4. Gestational diabetes mellitus

    Time frame: Delivery

    Binary yes/no

  5. Preterm birth

    Time frame: Delivery

    Binary yes/no; Delivery between 20w0d and 36w6d gestation

  6. Traumatic birth

    Time frame: Delivery

    Binary yes/no; Self-reported experience of birth as traumatic given concern for life or well-being of self or infant

  7. Postpartum post-traumatic stress symptoms

    Time frame: 6-12 weeks postpartum

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Emily S Miller, MD, MPH

CONTACT

[email protected]

401-274-1100 ext. 47452

Nina K Ayala, MD, MSCR

CONTACT

[email protected]

401-274-1100 ext. 43435

Sponsors and collaborators

Lead sponsor

Nina Ayala

Other

Collaborators

  • The Miriam Hospital

Registry information

Acronym: MORPHE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.