Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05840900

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

Led by Nina Ayala · Updated on 2025-08-24

100

Participants Needed

2

Research Sites

136 weeks

Total Duration

On this page

Sponsors

N

Nina Ayala

Lead Sponsor

T

The Miriam Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • English speaking
  • Nulliparous (no prior delivery at or greater than 20 weeks gestation)
  • Pregnant with a single fetus
  • Less than 20 weeks gestation
  • Low dispositional optimism (score of 14 or less on the Revised Life Orientation Test)
  • Owns a smartphone
Not Eligible

You will not qualify if you...

  • Plans to deliver at another institution
  • Currently practices mind-body exercises including mindfulness, meditation, or yoga at least once a week
  • Has pre-gestational hypertensive disorder
  • Has pre-gestational diabetes mellitus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Obstetrics and Gynecology Care Center

Providence, Rhode Island, United States, 02905

Actively Recruiting

2

Prenatal Diagnosis Center

Providence, Rhode Island, United States, 02905

Actively Recruiting

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Research Team

N

Nina K Ayala, MD, MSCR

CONTACT

E

Emily S Miller, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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