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NCT04445805 · ClinicalTrials.gov registry record · NA
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
A NA study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT04445805: Completed NA study, sponsored by Henry Ford Health System.
NCT04445805 is a NA study that has completed, run by Henry Ford Health System. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04445805, a NA study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these types of treatment will improve sleep and mood-related health risks in pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control.
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 Attention Control
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBTI)
- BEHAVIORAL Perinatal-enhanced Behavioral Therapy for Insomnia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
What the finished NCT04445805 record still lists
NCT04445805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Attention Control is the first listed.
NCT04445805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04445805 about?
NCT04445805 is a clinical study titled "Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms". The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these types of treatment will improve sleep and mood-related health risks in pregnancy and postpartum. The inv...
What is the current status of trial NCT04445805?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2021-03-15. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04445805?
The interventions under investigation include: Attention Control (BEHAVIORAL), Cognitive Behavioral Therapy for Insomnia (CBTI) (BEHAVIORAL), Perinatal-enhanced Behavioral Therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT04445805?
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 NCT04445805's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 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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