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Life sciences · Interventional Study
ClinicalTrials.gov · September 17, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07458698). This is a study registration, not published results. Lead sponsor: University of Massachusetts, Worcester. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Perinatal Anxiety, Anxiety Sensitivity, Perinatal Depression. Interventions: BEHAVIORAL: Digital mental health intervention. Primary outcome measures: Generalized Anxiety Disorder-7 (GAD-7) scale , Baseline, 4-weeks, and 8 weeks; Anxiety Sensitivity Index-3 (ASI-3) , Baseline, 4 weeks, 8 weeks; Treatment Evaluation Inventory Short Form (TEI-SF) , 8 weeks. Brief summary: 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.