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NCT03809598 · ClinicalTrials.gov registry record · NA

Roo Study on Mom and Baby Well-Being

A NA study, sponsored by Oregon Health and Science University.

Completed
Registry status
NA
Development phase
140
Enrollment target

NCT03809598: Completed NA study, sponsored by Oregon Health and Science University.

NCT03809598 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 140 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03809598, a NA study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
NA
Development phase
140 participants
Enrollment target

Study Summary

This study employs a randomized controlled trial of an established intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, to examine effects on various aspects of maternal psychological stress during pregnancy (magnitude and trajectories of stress) and offspring brain systems integral to healthy and maladaptive emotion regulation. This study considers other potential influences on maternal stress and psychiatric symptomatology, and infant behavior and brain development. The study population is pregnant women aged 21-45, and their infants.

Primary Outcome

Maternal psychological stress will be a composite of the Perceived Stress Scale (PSS), Beck Anxiety Inventory (BAI), and Pregnancy Distress Questionnaire (PDQ) The magnitude and trajectory of maternal psychological stress will be examined.

Interventions

  • BEHAVIORAL Mindfulness Based Cognitive Therapy

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2019-03-01
Est. Completion 2022-09-01
Phase NA

What the finished NCT03809598 record still lists

NCT03809598 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Mindfulness Based Cognitive Therapy is the first listed.

NCT03809598 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03809598 about?

NCT03809598 is a clinical study titled "Roo Study on Mom and Baby Well-Being". This study employs a randomized controlled trial of an established intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, to examine effects on various aspects of maternal psychological stress during pregnancy (magnitude and trajectories of stress) and offspring brain system...

What is the current status of trial NCT03809598?

This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2019-03-01. Estimated completion is 2022-09-01.

What interventions are being tested in trial NCT03809598?

The interventions under investigation include: Mindfulness Based Cognitive Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT03809598?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03809598's enrollment target sits among peer trials

140 713th of 2000 higher than 1,281 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03809598, the US trial registry maintained by the National Library of Medicine. NCT03809598 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.