RecruitingPhase 2NCT06430333

Sleep to Reduce Incident Depression Effectively in Peripartum


Sponsor

Henry Ford Health System

Enrollment

500 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether treating insomnia during pregnancy using an online Cognitive Behavioral Therapy for Insomnia (CBT-I) program can prevent the development of postpartum depression. Insomnia is known to be a strong risk factor for depression, and this study aims to break that link during the peripartum period. **You may be eligible if...** - You have a single (not multiple) pregnancy and are between 14 and 31 weeks along - You have been diagnosed with insomnia disorder lasting at least 1 month - Your insomnia severity score is 11 or higher - You do not currently have major depression (Edinburgh score below 13 at screening) - You are 18 years or older - You have reliable internet access - You are not currently in therapy for insomnia or major depression **You may NOT be eligible if...** - You have a high-risk pregnancy (such as pre-eclampsia or placenta previa with bleeding) - You have active suicidal thoughts - You work night or rotating shifts, or plan to travel across 3+ time zones in the 2 months after baseline - You have untreated restless legs syndrome - Your daytime sleepiness score is very high (Epworth Sleepiness Scale above 15) - You have a sleep or mental disorder that would make sleep restriction unsafe (such as narcolepsy, bipolar disorder, or epilepsy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPerinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Mindfulness-based sleep program for pregnant women.

OTHERTreatment-as-usual (TAU)

Usual practices from real-world care experiences.


Locations(1)

Henry Ford Medical Center

Novi, Michigan, United States

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NCT06430333


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