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NCT06430853

Psychobiological Interventions in Pregnancy

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Stanford University
~88 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Step count goalActigraph watch

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Edinburgh Postpartum Depression Scale (EPDS) Score
Measured over Randomization around 20 weeks gestation and end of study (around 37 weeks gestation).

Conditions

Pregnancy Complications
Mental Health Issue
Depression, Anxiety
Pregnancy, High Risk
Biological Clock Disturbance

Explore related trials

AnxietyDepressionHigh Risk PregnancyPregnancy

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Danielle M Panelli, MD, MS · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Able to read and write in English or Spanish
Presenting for a prenatal visit with a viable singleton gestation (no known lethal fetal anomaly or plan for pregnancy termination) between 18 and 20 weeks 0 days
Any history of depression or anxiety, defined as: 1) documented depression or anxiety in the medical record within the preceding 2 years; 2) baseline EPDS score \>=10 at intake prenatal visit; 3) baseline EPDS anxiety subscale 3A score \>=5

Exclusion

Known allergy to steel or rubber
Implantable medical device
Contraindication to physical activity such as a pre-existing cardiovascular condition or arrhythmia
Plan to relocate and/or deliver at another institution
Concurrent severe mental illness (diagnosis of bipolar disorder or schizophrenia)
Known lethal fetal anomaly or nonviable pregnancy
Baseline \>30 min per week of vigorous physical activity (from Pregnancy Physical Activity Questionnaire, PPAQ)

What this trial measures

  • Change in Edinburgh Postpartum Depression Scale (EPDS) ScoreRandomization around 20 weeks gestation and end of study (around 37 weeks gestation).

    The mean within person change in EPDS score between randomization and the end of the study will be compared between the 2 arms. The EPDS is a 10-question validated measure with a score range of 0-30 for depression and/or anxiety screening in pregnancy that has been translated into many languages. A score of \>=10 has been shown to be consistent with depressive symptoms.