Sleep to Reduce Incident Depression Effectively in Peripartum

Recruiting now · Phase 2

Conditions studied: Insomnia, Depression

In brief

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 facts

Study ID

NCT06430333

Run by

Henry Ford Health System

People needed

500

Starts

2024-12-10

Expected to finish

2028-02-29

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Singleton pregnancy, gestational week 14-31 at screening.
• DSM-5 Insomnia Disorder (≥1 month duration).
• Insomnia Severity Index (ISI) score ≥ 11.
• Edinburgh Postnatal Depression Scale score<13 at screening.
• No current DSM-5 Major Depression.
• Reliable internet access for treatment and assessments.
• Not currently engaged in therapy for major depression or insomnia disorder.
• Age 18 years or older.

You may not qualify if…

• High risk pregnancy (pre-eclampsia, placenta previa w/ hemorrhage, other conditions deemed serious risk to mother or fetus; hypertension and diabetes are allowed).
• Active suicidal intent.
• Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.
• Untreated RLS (treated RLS is OK).
• Excessive daytime sleepiness; Epworth Sleepiness Scale>15.
• Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).

Where it is running

• Henry Ford Medical Center — Novi, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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