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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Percentage of participants completing the assigned mindfulness exercises [Срок оценки: 8-week intervention period]
• Intervention acceptability [Срок оценки: After 8 week intervention period, approximately 16-28 weeks gestation.]

Вторичные конечные точки (7)

• Dispositional optimism [Срок оценки: Study enrollment and 6-12 weeks postpartum]
• Cesarean delivery [Срок оценки: Delivery]
• Hypertensive disorder of pregnancy [Срок оценки: 6-12 weeks postpartum]
• Gestational diabetes mellitus [Срок оценки: Delivery]
• Preterm birth [Срок оценки: Delivery]
• Traumatic birth [Срок оценки: Delivery]
• Postpartum post-traumatic stress symptoms [Срок оценки: 6-12 weeks postpartum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Obstetrics and Gynecology Care Center — Providence
• Prenatal Diagnosis Center — Providence

Публикации

• 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

Идентификаторы

NCT: NCT05840900 · 1983168

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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