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NCT06430333 · ClinicalTrials.gov registry record · Phase 2
Sleep to Reduce Incident Depression Effectively in Peripartum
A Phase 2 study of Depression and Insomnia, sponsored by Henry Ford Health System.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT06430333 is a Phase 2 study of Depression and Insomnia that is actively recruiting participants, run by Henry Ford Health System. The registered enrollment target is 500 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06430333, a Phase 2 study of Depression and Insomnia, is actively recruiting participants, sponsored by Henry Ford Health System.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
- OTHER Treatment-as-usual (TAU)
Study Locations (1)
Michigan
- Henry Ford Medical Center - Novi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-12-10 |
| Est. Completion | 2028-02-29 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06430333
The ClinicalTrials.gov registry entry for NCT06430333 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (36% lower). The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) is the first listed.
NCT06430333 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT06430333 about?
NCT06430333 is a clinical study titled "Sleep to Reduce Incident Depression Effectively in Peripartum". 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 int...
What is the current status of trial NCT06430333?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2024-12-10. Estimated completion is 2028-02-29.
What conditions does trial NCT06430333 study?
This clinical trial studies the following conditions: Depression, Insomnia.
What interventions are being tested in trial NCT06430333?
The interventions under investigation include: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) (BEHAVIORAL), Treatment-as-usual (TAU) (OTHER).
Who is sponsoring clinical trial NCT06430333?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06430333 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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