Sleep to Reduce Incident Depression Effectively in Peripartum (NCT06430333) | Clinical Trial Compass
RecruitingPhase 2
Sleep to Reduce Incident Depression Effectively in Peripartum
United States500 participantsStarted 2024-12-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Singleton pregnancy, gestational week 14-31 at screening.
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Comparative effectiveness between PUMAS and standard care on changes in insomnia symptoms.
Timeframe: The investigators will examine change in ISI from Pretreatment Baseline to Posttreatment (8 weeks after baseline), and monthly for 1 year after childbirth..
2
Comparative effectiveness of PUMAS and standard care on prevention of perinatal depression.
Timeframe: The investigators will examine onset of perinatal depression (EPDS scores 13 or higher) at posttreatment (8 weeks after baseline) and assessed monthly for 1 year after childbirth.