Mindfulness app for improving optimism and health in pregnant women
Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study
NA · Women and Infants Hospital of Rhode Island · NCT05840900
This study tests whether a mindfulness app can help first-time pregnant women with low optimism feel better and improve their health during and after pregnancy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island (other) |
| Locations | 2 sites (Providence, Rhode Island and 1 other locations) |
| Trial ID | NCT05840900 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and acceptability of a mindfulness phone application called Expectful, aimed at first-time mothers with low dispositional optimism during early pregnancy. The study will randomly assign participants to either use the app for 8 weeks or receive standard pregnancy care. It aims to assess the app's impact on dispositional optimism, adverse pregnancy outcomes, and postpartum post-traumatic stress symptoms. The trial will involve 100 women recruited from Women and Infants Hospital of Rhode Island.
Who should consider this trial
Good fit: Ideal candidates are first-time mothers who are less than 20 weeks pregnant, nulliparous, English-speaking, and have low dispositional optimism.
Not a fit: Patients who are already engaged in regular mind-body practices or have pre-existing hypertensive or diabetic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance mental health and reduce adverse outcomes for pregnant women with low optimism.
How similar studies have performed: While mindfulness interventions have shown promise in other populations, this specific approach tailored for perinatal health is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Providence, Rhode Island and 1 other locations
- Obstetrics and Gynecology Care Center — Providence, Rhode Island, United States (RECRUITING)
- Prenatal Diagnosis Center — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Study coordinator: Nina K Ayala, MD, MSCR
- Email: nayala@carene.org
- Phone: 401-274-1100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Psychiatric Disorders, dispositional optimism, mindfulness, adverse perinatal outcomes