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Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

NCT07458698 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Perinatal Anxiety
  • Anxiety Sensitivity
  • Perinatal Depression

Interventions

BEHAVIORAL

Digital mental health intervention

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Massachusetts, Worcester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-12-31
Completion
2029-08-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07458698 on ClinicalTrials.gov