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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: Recruiting Phase 2 study of Depression and Insomnia, sponsored by Henry Ford Health System.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT06430333 shows while recruiting
NCT06430333 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (36% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06430333's enrollment target sits among peer trials
500 79th of 679 higher than 592 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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