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mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record status
This record was last updated August 5, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Eligibility criteria expanded, about 1 wordv9
  2. Primary and study completion dates: Mar 1, 2025 to Dec 2025
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 3 of 9 entries
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Start date: Jun 1, 2022 to Jun 14, 2022v6
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Sep 1, 2022 to Jun 1, 2022
    v5
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  1. Interventions: Nature sounds (Behavioral), mHealth mindfulness app (Behavioral) to Stress reduction program 'A' (Behavioral), Stress reduction program 'B' (Behavioral)
    • Study title expanded, about 9 words
    v4
  2. Phase: Not applicable to Phase 3
    • Primary completion date: Apr 30, 2024 to Mar 1, 2025
    • Start date: May 1, 2022 to Sep 1, 2022
    • Study completion date: Jun 30, 2024 to Mar 1, 2025
    v3
  3. Start date: Feb 1, 2022 to May 1, 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) compare the effectiveness of two digitally-delivered self-paced stress reduction programs in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.
Trial Details
NCT Number NCT05186272
Lead Sponsor Kaiser Permanente
Conditions
(from sponsor)		 Post Partum Depression, Perinatal Depression
Related terms Depression, Postpartum
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov