RECRUITING Not applicable ClinicalTrials.gov

Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

Sponsor: University of Massachusetts, Worcester • ClinicalTrials.gov ID: NCT07458698

Registry updated: 2026-09-17

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Description

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.

Interventions

Digital mental health intervention (Behavioral)
Reaching Calm is a digital intervention designed to prevent anxiety in pregnant patients. It includes: (1) a digital Anxiety Sensitivity Intervention delivered via text messages and web-based psychoeducation and exposure exercises; (2) training for obstetric (OB) professionals to support anxiety prevention and program integration; and (3) an implementation protocol that adapts workflows to make Reaching Calm accessible during routine OB care. The intervention uses personalized content and resources based on participant feedback.

Eligibility criteria

Inclusion Criteria: * Receiving prenatal care at participating obstetric practice * Endorsed mild to moderate anxiety (GAD-7 score 5-15) * Currently pregnant (gestational age \<32) * Started Reaching Calm digital intervention, if in intervention group Exclusion Criteria: * Not pregnant * Unable to participate in 60-minute interview * Unwilling to be audio recorded * GAD-7 \<5, or GAD-7≥15 * Adults unable to consent (adults lacking capacity) * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Non-English-speaking

Conditions

Perinatal Anxiety Anxiety Sensitivity Perinatal Depression

Locations

UMass Memorial Medical Group - Montachusett Women's Health — Leominster, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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