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Sleep to Reduce Incident Depression Effectively in Peripartum

NCT06430333 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • David A Kalmbach, PhD · Henry Ford Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06430333 on ClinicalTrials.gov