Actively Recruiting
Sleep to Reduce Incident Depression Effectively in Peripartum
Led by Henry Ford Health System · Updated on 2026-04-17
500
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Sleep to Reduce Incident Depression Effectively in Peripartum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy between 14 and 31 weeks gestation at screening
- Diagnosis of DSM-5 Insomnia Disorder lasting at least 1 month
- Insomnia Severity Index (ISI) score of 11 or higher
- Edinburgh Postnatal Depression Scale score less than 13 at screening
- No current DSM-5 Major Depression diagnosis
- Reliable internet access for treatment and assessments
- Not currently receiving therapy for major depression or insomnia disorder
- Age 18 years or older
You will not qualify if you...
- High risk pregnancy conditions such as pre-eclampsia or placenta previa with hemorrhage (hypertension and diabetes allowed)
- Active suicidal intent
- Night or rotating shift work, or planned travel across 3 or more time zones within 2 months after baseline
- Untreated restless leg syndrome (treated RLS allowed)
- Excessive daytime sleepiness (Epworth Sleepiness Scale score over 15)
- Uncontrolled sleep or mental disorders unsafe for sleep restriction (e.g., narcolepsy, bipolar disorder, epilepsy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henry Ford Medical Center
Novi, Michigan, United States, 48377
Actively Recruiting
Research Team
D
David A Kalmbach, PhD
CONTACT
C
Christopher L Drake, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here