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Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

Study acronym: INSPIRE
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed
    • Primary completion date changed from estimate of Apr 30, 2026 to Feb 13, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Primary and study completion dates: Aug 31, 2025 to Apr 30, 2026v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 14, 2023 to Feb 1, 2023
    • Site details revised
    v4
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  1. Start date: Sep 1, 2022 to Jan 14, 2023v3
  2. Secondary endpoints: details revised at 2 of 4 entriesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.
Trial Details
NCT Number NCT05356364
Lead Sponsor Henry Ford Health System
Conditions
(from sponsor)		 Insomnia, Depression
Related terms Depression, Sleep Initiation and Maintenance Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov