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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postpartum Psychiatric Disorders

Intervention / Treatment
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* Behavioral: Digital Mindfulness Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dispositional optimism, mindfulness, adverse perinatal outcomes