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Sleep to Reduce Incident Depression Effectively in Peripartum

Study acronym: STRIDE P
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Site contact updatedv5
  3. Phase: Phase 3 to Phase 2
    • Site contact updated
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Phase: Not applicable to Phase 3v2 Show 8 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints revised (2)
    • Primary and study completion dates: Sep 30, 2028 to Feb 29, 2028
    • Start date changed from estimate of Oct 1, 2025 to Dec 10, 2024
    • Secondary endpoint revised
    • Site details revised
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 3 words
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06430333
Lead Sponsor Henry Ford Health System
Conditions
(from sponsor)		 Insomnia, Depression
Related terms Depression, Rumination Syndrome, Sleep Initiation and Maintenance Disorders
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov