Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Intervention acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and clinicians will not be blinded, but the outcomes assessor and analytic teams will be blinded to participant allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Intervention acceptability
时间窗: After 8 week intervention period, approximately 16-28 weeks gestation.
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.
Percentage of participants completing the assigned mindfulness exercises
时间窗: 8-week intervention period
The intervention will be considered feasible if ≥75% participants complete \>50% of the assigned daily mindfulness exercises over the 8-week intervention period
次要结局
- Gestational diabetes mellitus(Delivery)
- Preterm birth(Delivery)
- Dispositional optimism(Study enrollment and 6-12 weeks postpartum)
- Cesarean delivery(Delivery)
- Hypertensive disorder of pregnancy(6-12 weeks postpartum)
- Traumatic birth(Delivery)
- Postpartum post-traumatic stress symptoms(6-12 weeks postpartum)
研究者
Nina Ayala
Attending Physician, Maternal-Fetal Medicine
Women and Infants Hospital of Rhode Island