PUMAS for Insomnia and Depression Prevention in Pregnancy
This study is looking at a program called Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) to see if it can help pregnant women with insomnia and reduce their risk of depression. PUMAS is a mindfulness-based sleep program. Researchers will compare PUMAS to usual care (what doctors normally do). They want to see if PUMAS helps improve insomnia symptoms and prevents depression during pregnancy and after childbirth. You might be able to join if you are 18 or older, pregnant with one baby, between 14 and 31 weeks along, have insomnia, and don't currently have major depression. The study aims to enroll 500 participants.
- Study design
- This interventional study will compare the PUMAS program to usual care. It plans to enroll 500 women.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your insomnia symptoms and depression risk will be checked at 8 weeks after starting the program, and then monthly for one year after childbirth.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sleep to Reduce Incident Depression Effectively in Peripartum
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- David A Kalmbach, PhD · PRINCIPAL_INVESTIGATOR · Henry Ford Health
Who to contact
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What this trial measures
- Comparative effectiveness between PUMAS and standard care on changes in insomnia symptoms.The investigators will examine change in ISI from Pretreatment Baseline to Posttreatment (8 weeks after baseline), and monthly for 1 year after childbirth..
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.
- Comparative effectiveness of PUMAS and standard care on prevention of perinatal depression.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.
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.