Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Mindfulness Training.
- Who it may be relevant to
- Registry conditions: Postpartum Psychiatric Disorders. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Digital Mindfulness Training
Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful
Primary outcome measures
- Percentage of participants completing the assigned mindfulness exercises [Time frame: 8-week intervention period]
- Intervention acceptability [Time frame: After 8 week intervention period, approximately 16-28 weeks gestation.]
Secondary outcome measures (7)
- Dispositional optimism [Time frame: Study enrollment and 6-12 weeks postpartum]
- Cesarean delivery [Time frame: Delivery]
- Hypertensive disorder of pregnancy [Time frame: 6-12 weeks postpartum]
- Gestational diabetes mellitus [Time frame: Delivery]
- Preterm birth [Time frame: Delivery]
- Traumatic birth [Time frame: Delivery]
- Postpartum post-traumatic stress symptoms [Time frame: 6-12 weeks postpartum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Obstetrics and Gynecology Care Center — Providence
- Prenatal Diagnosis Center — Providence
Publications
- Chang E, Lewkowitz AK, Unger JA, Garfield CF, Miller ES. Smartphone Applications to Support Perinatal Mental Health. Obstet Gynecol. 2026 Feb 1;147(2):229-238. doi: 10.1097/AOG.0000000000006139. Epub 2025 Dec 18. PMID 41411652
Identifiers
NCT: NCT05840900 · 1983168