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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: Completed NA study, sponsored by Henry Ford Health System.
NCT04443959 is a NA study that has completed, run by Henry Ford Health System. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia. ISI scores \< 8 after treatment indicate remission.
Interventions
- BEHAVIORAL PUMAS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2022-11-22 |
| Phase | NA |
What the finished NCT04443959 record still lists
NCT04443959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which PUMAS is the first listed.
NCT04443959 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04443959's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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