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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
BehavioralMindfulness-based sleep program for pregnant women.
Treatment-as-usual (TAU)
Other interventionUsual practices from real-world care experiences.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)Experimental treatment 1 intervention
Group B: Treatment-as-usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Comparative effectiveness between PUMAS and standard care on changes in insomnia symptoms.
The Insomnia Severity Index is a commonly used self-report measure of insomnia symptoms that has been validated in peripartum. ISI scores range from 0 to 28 with higher scores indicating greater insomnia severity.
Time frame
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.
The Edinburgh Postnatal Depression Scale (EDPS) is the most widely use depression measure in pregnancy and postpartum. EPDS scores range from 0 to 30 with higher scores indicating greater depression severity.
Time frame
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.Secondary outcomes
1
Comparative effectiveness between PUMAS and standard care on nocturnal cognitive arousal symptoms.
The Pre-Sleep Arousal Scale's Cognitive factor (PSASC) is a self-report measure of nocturnal cognitive arousal that has been validated in peripartum. PSASC scores range 8 to 40 with higher scores indicating greater nocturnal cognitive arousal.
Time frame
The investigators will examine changes in PSASC from Pretreatment baseline to Posttreatment (8 weeks later).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov