Recruiting

Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

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…

ClinicalTrials.gov IDNCT07458698
PhaseNA
Enrollment60
SponsorUniversity of Massachusetts, Worcester
Age18 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Perinatal Anxiety, Anxiety Sensitivity, Perinatal Depression

About this study

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

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.