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App-based 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

MORPHE Trial 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.Check my eligibility

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.See study design

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.

MORPHE Trial 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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 8 week intervention period, approximately 16-28 weeks gestation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention acceptability

Percentage of participants completing the assigned mindfulness exercises

Secondary outcome measures

Cesarean delivery

Dispositional optimism

Gestational diabetes mellitus

+4 more

MORPHE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Miriam HospitalOTHER

238 Previous Clinical Trials

37,375 Total Patients Enrolled

Nina AyalaLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals eligible for enrollment in this clinical research study?

"Indeed, the details on clinicaltrials.gov affirm that this research study is presently in pursuit of participants. Originally disclosed on February 20th, 2024, and last revised on March 29th, 2024, the trial aims to enroll a total of 100 patients across two designated sites."

Answered by AI

Are patients currently able to enroll in this ongoing study?

"Indeed, information available on clinicaltrials.gov confirms the active recruitment status of this particular trial. Initially shared on February 20th, 2024, and last revised on March 29th, 2024, the study aims to enroll a total of 100 participants distributed across two distinct sites."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"The main focus of this research, to be assessed over an approximate 8-week intervention phase, is the acceptability of the intervention. Secondary measures encompass traumatic birth experiences categorized as binary yes or no based on perceived threat to self or infant well-being; gestational diabetes mellitus classified as a binary outcome; and postpartum post-traumatic stress symptoms gauged using the PTSD Checklist for DSM-5 (PCL-5), with scores ranging from 0 to 80 indicating severity of symptoms."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Nina Ayala 2024. "Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05840900.

All > Mindfulness