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NCT04443959 · ClinicalTrials.gov registry record · NA
Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.
A NA study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04443959 is a NA study that has completed, run by Henry Ford Health System. The registered enrollment target is 12 participants.
The verdict
NCT04443959, a NA study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Over half of pregnant and postpartum women experience clinical insomnia. However, treatment options are very limited for pregnant women and moms of newborns. Sleep aids are not considered safe during pregnancy and may increase risks about safety for mom and baby during postpartum. Recent clinical trials show that behavioral and mindfulness-based treatments can safely improve sleep and mood during pregnancy. Yet, no published studies to date have combined behavioral sleep treatment with mindfulness-based stress reduction to improve sleep and mood at the same time in pregnant and postpartum women. This study is the first to combine behavioral sleep strategies with mindfulness-meditation to improve sleep and psychological wellbeing of expecting and new moms. The purpose of this research study is to examine the effectiveness of a mindfulness-based intervention for prenatal insomnia via telemedicine format to improve sleep and mood as well as reduce stress in pregnant women.
Interventions
- BEHAVIORAL PUMAS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2022-11-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04443959
The ClinicalTrials.gov registry entry for NCT04443959 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PUMAS is the first listed.
NCT04443959 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04443959 about?
NCT04443959 is a clinical study titled "Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.". Over half of pregnant and postpartum women experience clinical insomnia. However, treatment options are very limited for pregnant women and moms of newborns. Sleep aids are not considered safe during pregnancy and may increase risks about safety for mom and baby during postpartum. Recent clinical tr...
What is the current status of trial NCT04443959?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2022-08-15. Estimated completion is 2022-11-22.
What interventions are being tested in trial NCT04443959?
The interventions under investigation include: PUMAS (BEHAVIORAL).
Who is sponsoring clinical trial NCT04443959?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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