Sleep to Reduce Incident Depression Effectively in Peripartum
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHenry Ford Health System
About this trial
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 criteria
Qualifiers
Singleton pregnancy, gestational week 14-31 at screening.
DSM-5 Insomnia Disorder (≥1 month duration).
Insomnia Severity Index (ISI) score ≥ 11.
Edinburgh Postnatal Depression Scale score<13 at screening.
Disqualifiers
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.
Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.
Untreated RLS (treated RLS is OK).
Trial design
Treatments tested in this trial
- Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
- Treatment-as-usual (TAU)
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov