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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Perinatal Depression

Clinical Trials on Digital mental health intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings