WithdrawnNot Applicable

Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders

Stopped: no funding

0Started 2021-07-01

Plain-language summary

The primary aim of the study is to investigate whether a novel mobile App-based behavioral intervention in pregnant women can: (1) prevent and/or decrease the incidence of perinatal mood disorders (2) decrease the severity and/or duration of perinatal mood disorders in affected participants (3) increase access of pregnant women to behavioral intervention and support tools (4) increase the satisfaction of pregnant women with their prenatal care.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to read and speak English * Have a low-risk singleton pregnancy with more than 24 weeks of gestation * Have smartphone with internet access * Failure to meet criteria for a diagnosis of MDD in the last two months Exclusion Criteria: * Physical or mental disorders which would interfere with their ability to participate in the study * High-risk pregnancy * Give birth to a newborn at still-birth or a newborn with congenital anomalies and/or Medical complications that require special care in hospital * Infant has a birth weight lower than 2,500 grams * Infant has a 5-minute Apgar score lower than 7

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postpartum Depression Symptoms

Timeframe: 3rd trimester pregnancy till 6 months postpartum

Trial details

NCT IDNCT04914299

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

View on ClinicalTrials.gov More Perinatal Depression trials