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Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 15, 2026 to Aug 15, 2026
    • Eligibility criteria expanded, about 12 words
    • Publications: details revised at 2 of 2 entries
    • Study description expanded, about 3 words
  2. Start date: Jul 1, 2026 to Jul 15, 2026v4
  3. Start date: May 1, 2026 to Jul 1, 2026v3
  4. Secondary endpoints: details revised at 1 of 1 entryv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to find out if a digital program called Reaching Calm can help prevent anxiety in women who are pregnant. The study will offer Reaching Calm at obstetric practices where participants receive prenatal care. The study focuses on people who may be at greater risk for experiencing anxiety during or after pregnancy. The main questions this study aims to answer are: * Is Reaching Calm easy to use and acceptable to both participants and healthcare professionals? * Does Reaching Calm help reduce risk for anxiety among participants? * Does personalizing the digital program help participants stay involved? Researchers will compare obstetric practices that offer Reaching Calm to those providing usual care. Participants will: * Receive text messages and use a web-based platform for learning about anxiety and coping strategies * Respond to surveys about their experiences and symptoms * Some will take part in interviews and focus groups to share their views * Healthcare professionals will receive training on how to support the program The study will monitor how many people join, stay involved, and how the program affects their well-being. The results will help prepare for a larger study that could lead to wider use of Reaching Calm across the country.
Trial Details
NCT Number NCT07458698
Lead Sponsor University of Massachusetts, Worcester
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Perinatal Anxiety, Anxiety Sensitivity, Perinatal Depression
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov