Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

March 9, 2026 updated by: Martha Zimmermann, University of Massachusetts, Worcester

Reaching Calm Pilot (K23)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Perinatal anxiety disorders affect up to one in five women during pregnancy or after giving birth, leading to negative outcomes for both parents and children. Mental health conditions are the leading cause of maternal mortality in the United States, and untreated mood and anxiety disorders have significant economic and societal impact. Fewer than seven percent of those affected receive treatment. Preventing anxiety before it develops could significantly improve the health and well-being of perinatal individuals and their families.

This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a digital intervention called Reaching Calm, designed to prevent anxiety during pregnancy. Reaching Calm is delivered through obstetric (OB) clinical settings to increase accessibility and engagement. The intervention, developed using community-engaged and user-centered design approaches, is especially tailored for perinatal individuals experiencing economic challenges. Reaching Calm consists of three integrated components:

  • A brief digital Anxiety Sensitivity Intervention (ASI), delivered via text messages and a web-based interface, incorporating psychoeducation and exposure exercises to reduce anxiety sensitivity, a risk factor for anxiety and depression.
  • Training for OB professionals on perinatal anxiety prevention and integration of the digital program into routine care.
  • An implementation protocol to facilitate seamless integration into OB practice workflows.

The study is a pilot cluster randomized controlled trial (RCT). Four OB practices will be randomized, with two offering Reaching Calm and two continuing with Usual Care. The intervention and observation period will last approximately four months for each participant, to align with the typical prenatal care timeline and allow sufficient time for engagement with the digital program.

The study will evaluate participant outcomes via surveys and intervention implementation via surveys with obstetric practice leadership and practice chart reviews.

A subset of participants will participate in interviews for more in-depth feedback, and a subset of professionals will join focus groups. Micro-randomization within participants will be used to evaluate whether personalization features (such as tailored content and support resources) increase engagement with the digital intervention. The extended RE-AIM implementation science framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) will guide evaluation.

Findings from this pilot study will inform preparation and design of a larger-scale hybrid effectiveness-implementation trial of Reaching Calm. This work aims to create scalable, accessible, and effective solutions to prevent perinatal anxiety.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Reaching Calm
  • Anxiety Sensitivity Intervention
No Intervention: Prenatal care continues as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder-7 (GAD-7) scale
Time Frame: Baseline, 4-weeks, and 8 weeks
Anxiety symptoms, scores range from 0-21 with higher scores indicating greater anxiety symptom severity
Baseline, 4-weeks, and 8 weeks
Anxiety Sensitivity Index-3 (ASI-3)
Time Frame: Baseline, 4 weeks, 8 weeks
Anxiety sensitivity, scores range from 0-72 with higher scores indicating greater anxiety sensitivity
Baseline, 4 weeks, 8 weeks
Treatment Evaluation Inventory Short Form (TEI-SF)
Time Frame: 8 weeks
Acceptability, scores range from 9-45 with higher scores indicating greater acceptability
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 4 weeks, 8 weeks
Depression symptoms, scores range from 0-27 with higher scores indicating greater depression symptom severity
Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00001942
  • K23MH137382 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant survey data will be made available.

IPD Sharing Time Frame

All aggregate data and individual-level survey data that can be shared publicly will be deposited in the OSF generalist repository by 8/31/2029 and will be available for at least 10 years.

IPD Sharing Access Criteria

Data will be findable for the research community via the DOI which will be referenced in the publication to allow the research community access to the data used in publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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