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Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

RECRUITINGN/ASponsored by University of Massachusetts, Worcester
Actively Recruiting
PhaseN/A
SponsorUniversity of Massachusetts, Worcester
Started2026-08-15
Est. completion2027-12-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions5

AnxietyAnxiety SensitivityDepressionPerinatal AnxietyPerinatal Depression

Locations1 site

UMass Memorial Medical Group - Montachusett Women's Health
Leominster, Massachusetts, 01453
Carolyn Friedhoff Alvarez

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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