Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

Part of paid clinical trials in Leominster, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT07458698
Status
Recruiting
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Conditions

  • Anxiety Sensitivity
  • Perinatal Anxiety
  • Perinatal Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Mar 9, 2026
Start date
Aug 15, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Aug 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Reaching Calm
    Reaching Calm is a a multicomponent digital intervention to prevent perinatal anxiety in OB settings including a 1) digital Anxiety Sensitivity Intervention with text messages and web-based interface, 2) OB professional training, and 3) implementation protocol to integrate anxiety prevention into the OB workflow.
  • No Intervention: Prenatal care continues as usual
    Prenatal care continues as usual

Primary Outcome Measure

Generalized Anxiety Disorder-7 (GAD-7) scale [ Time Frame: Baseline, 4-weeks, and 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Memorial Medical Group - Montachusett Women's HealthLeominsterMassachusetts01453
Carolyn Friedhoff Alvarez

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By research site
UMass Memorial Medical Group - Montachusett Women's Health· Leominster, MA

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