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RECRUITING
NCT06430333
PHASE2

Sleep to Reduce Incident Depression Effectively in Peripartum

Sponsor: Henry Ford Health System

View on ClinicalTrials.gov

Summary

Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-12-10

Completion Date

2028-02-29

Last Updated

2025-02-24

Healthy Volunteers

No

Interventions

BEHAVIORAL

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Mindfulness-based sleep program for pregnant women.

OTHER

Treatment-as-usual (TAU)

Usual practices from real-world care experiences.

Locations (1)

Henry Ford Medical Center

Novi, Michigan, United States