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

NCT ID: NCT05840900

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2026-10-01

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.

Conditions

Postpartum Psychiatric Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

App-based mindfulness training

App-based daily mindfulness training Standard prenatal and pregnancy care

Group Type: EXPERIMENTAL

Digital Mindfulness Training

Intervention Type: BEHAVIORAL

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

Usual Care

Standard prenatal and pregnancy care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Digital Mindfulness Training

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: collaborator

Nina Ayala

OTHER

Sponsor Role: lead

Responsible Party

Nina Ayala

Attending Physician, Maternal-Fetal Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Obstetrics and Gynecology Care Center

Providence, Rhode Island, United States

Site Status: RECRUITING

Prenatal Diagnosis Center

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nina K Ayala, MD, MSCR

Role: CONTACT

nayala@carene.org

401-274-1100 ext. 43435

Emily S Miller, MD, MPH

Role: CONTACT

emmiller@carene.org

401-274-1100 ext. 47452

Facility Contacts

Nina K. Ayala, MD

Role: primary

Nina K. Ayala, MD

Role: primary

Other Identifiers

1983168

Identifier Type: -

Identifier Source: org_study_id