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

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Psychiatric Disorders
• Intervention / Treatment: Behavioral: Digital Mindfulness Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nina K Ayala, MD, MSCR; Phone Number: 43435 401-274-1100; Email: nayala@carene.org
• Study Contact Backup: Name: Emily S Miller, MD, MPH; Phone Number: 47452 401-274-1100; Email: emmiller@carene.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Obstetrics and Gynecology Care Center
      • Contact: Nina K. Ayala, MD
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Prenatal Diagnosis Center
      • Contact: Nina K. Ayala, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App-based mindfulness training; App-based daily mindfulness training Standard prenatal and pregnancy care	Behavioral: Digital Mindfulness Training; Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful
No Intervention: Usual Care; Standard prenatal and pregnancy care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	After 8 week intervention period, approximately 16-28 weeks gestation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Study enrollment and 6-12 weeks postpartum
Cesarean delivery	Binary yes/no	Delivery
Hypertensive disorder of pregnancy	Binary yes/no; includes gestational hypertension, pre-eclampsia with or without severe features, HELLP syndrome or eclampsia	6-12 weeks postpartum
Gestational diabetes mellitus	Binary yes/no	Delivery
Preterm birth	Binary yes/no; Delivery between 20w0d and 36w6d gestation	Delivery
Traumatic birth	Binary yes/no; Self-reported experience of birth as traumatic given concern for life or well-being of self or infant	Delivery
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)	6-12 weeks postpartum

Collaborators and Investigators

• Sponsor: Nina Ayala
• Collaborators: The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness; dispositional optimism; adverse perinatal outcomes
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: 1983168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No