Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Massachusetts, Worcester

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Not pregnant

Unable to participate in 60-minute interview

Unwilling to be audio recorded

GAD-7 <5, or GAD-7≥15

Trial design

Treatments tested in this trial

  • Digital mental health intervention

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Massachusetts, Worcester

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator