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Mindfulness Training for Postpartum Depression (MORPHE Trial)
N/A
Recruiting
Research Sponsored by Nina Ayala
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a mindfulness phone app called Expectful can help improve the mental health of first-time mothers with low optimism during pregnancy. The study will also look at how using the app affects
Who is the study for?
This trial is for first-time pregnant mothers with low optimism early in pregnancy (less than 20 weeks), who speak English, can consent, and have a smartphone. They must not have had a prior delivery at or beyond 20 weeks gestation.
What is being tested?
The study tests the use of Expectful, a mindfulness app designed for pregnant women, against standard care to see if it improves optimism and reduces negative outcomes like cesarean deliveries and postpartum stress.
What are the potential side effects?
Since this intervention involves digital mindfulness training through an app, there are no direct physical side effects. However, users may experience emotional discomfort or increased anxiety if they find engaging with the app stressful.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 8 week intervention period, approximately 16-28 weeks gestation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 8 week intervention period, approximately 16-28 weeks gestation.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intervention acceptability
Percentage of participants completing the assigned mindfulness exercises
Secondary study objectives
Cesarean delivery
Dispositional optimism
Gestational diabetes mellitus
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: App-based mindfulness trainingExperimental Treatment1 Intervention
App-based daily mindfulness training Standard prenatal and pregnancy care
Group II: Usual CareActive Control1 Intervention
Standard prenatal and pregnancy care
Find a Location
Who is running the clinical trial?
The Miriam HospitalOTHER
244 Previous Clinical Trials
37,778 Total Patients Enrolled
Nina AyalaLead Sponsor
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