Mindfulness-based sleep program for pregnant women to prevent depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a mindfulness-based sleep program called Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) in reducing the risk of perinatal depression (PND) among pregnant women experiencing insomnia. The study will involve 500 women who are between 14 to 31 weeks of gestation and have been diagnosed with insomnia disorder. Participants will receive either the PUMAS intervention or treatment-as-usual (TAU) while their sleep quality, cognitive arousal, and depressive symptoms are monitored. The trial seeks to address the high prevalence of insomnia and its link to PND, particularly in the context of the COVID-19 pandemic.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Henry Ford Medical Center
  Novi, Michigan, United States Recruiting

Study contacts

• Principal investigator: David A Kalmbach, PhD — Henry Ford Health
• Study coordinator: David A Kalmbach, PhD
• Email: dkalmba1@hfhs.org
• Phone: 248-325-3938

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.