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

Last updated: August 18, 2025
Sponsor: Nina Ayala
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Digital Mindfulness Training

Clinical Study ID

NCT05840900
1983168
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Plan to deliver at another institution

  • Ongoing (≥1/week) mind-body practice including mindfulness training, meditation oryoga

  • Pre-gestational hypertensive disorder

  • Pre-gestational diabetes mellitus

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Digital Mindfulness Training
Phase:
Study Start date:
February 20, 2024
Estimated Completion Date:
October 01, 2026

Study 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.

Connect with a study center

  • Obstetrics and Gynecology Care Center

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • Prenatal Diagnosis Center

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Obstetrics and Gynecology Care Center

    Providence 5224151, Rhode Island 5224323 02905
    United States

    Active - Recruiting

  • Prenatal Diagnosis Center

    Providence 5224151, Rhode Island 5224323 02905
    United States

    Active - Recruiting

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