NCT07458698

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
41mo left

Started May 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Aug 2029

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 4, 2026

Last Update Submit

March 9, 2026

Conditions

Perinatal AnxietyAnxiety SensitivityPerinatal Depression

Keywords

Perinatal anxietyObstetric carePerinatal mental healthDigital mental healthEngagement

Outcome Measures

Primary Outcomes (3)

  • Generalized Anxiety Disorder-7 (GAD-7) scale

    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)

    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)

    Acceptability, scores range from 9-45 with higher scores indicating greater acceptability

    8 weeks

Secondary Outcomes (1)

  • Patient Health Questionnaire-9 (PHQ-9)

    Baseline, 4 weeks, 8 weeks

Study Arms (2)

Reaching Calm

EXPERIMENTAL

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

Prenatal care continues as usual

NO INTERVENTION

Prenatal care continues as usual

Interventions

Digital mental health interventionBEHAVIORAL

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.

Also known as: Reaching Calm, Anxiety Sensitivity Intervention
Reaching Calm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Zimmermann M, Yonkers KA, Tabb KM, Schaefer A, Peacock-Chambers E, Clare CA, Boudreaux ED, Lemon SC, Byatt N, Tulu B. Developing personas to inform the design of digital interventions for perinatal mental health. JAMIA Open. 2024 Nov 1;7(4):ooae112. doi: 10.1093/jamiaopen/ooae112. eCollection 2024 Dec.

    PMID: 39494447BACKGROUND

  • Zimmermann M, Yonkers KA, Tulu B, Ford L, Peacock-Chambers E, Clare CA, Boudreaux ED, Lemon SC, Byatt N. Adapting an Anxiety Sensitivity Intervention for Perinatal Mental Health: Development of a Digital Intervention. J Nerv Ment Dis. 2025 Jul 1;213(7):167-179. doi: 10.1097/NMD.0000000000001841. Epub 2025 Jul 11.

    PMID: 40642841BACKGROUND

Central Study Contacts

Martha Zimmermann, PhD

CONTACT

617-870-4798martha.zimmermann1@umassmed.edu

Reaching Calm Study Team

CONTACT

978-732-4583RCAppStudy@umassmed.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

August 31, 2029

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified participant survey data will be made available.

Shared Documents
STUDY PROTOCOL
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.
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.