Mindfulness-based sleep program for pregnant women to prevent depression

Sleep to Reduce Incident Depression Effectively in Peripartum

This study is testing a mindfulness-based sleep program to see if it can help pregnant women with insomnia reduce their risk of depression.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Henry Ford Health System (Academic / other)
• Locations: 1 site (Novi, Michigan)
• Trial ID: NCT06430333 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women between 14 to 31 weeks of gestation who have been diagnosed with insomnia disorder.

Not a fit: Patients with high-risk pregnancies or those currently experiencing major depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly reduce the incidence of perinatal depression in pregnant women by improving their sleep quality.

How similar studies have performed: Previous studies have shown promising results with mindfulness-based interventions for insomnia and depression, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Novi, Michigan

• 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

Conditions Insomnia; Depression; pregnancy; postpartum; sleep; worry; rumination