Perinatal AnxietyNCT07458698
Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders
A study testing Digital mental health intervention in people with Perinatal Anxiety and Anxiety Sensitivity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Anxiety, Anxiety Sensitivity, Perinatal Depression
- What is being tested?
- Digital mental health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 31 Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Memorial Medical Group - Montachusett Women's Health
Leominster, Massachusetts, 01453
Carolyn Friedhoff Alvarez
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Perinatal Anxiety, Anxiety Sensitivity, Perinatal Depression
- Being tested
- Digital mental health intervention
- Keywords
- Perinatal anxiety, Obstetric care, Perinatal mental health, Digital mental health, Engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital mental health interventionBehavioural
Also called Reaching Calm, Anxiety Sensitivity 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital mental health intervention |
| Prenatal care continues as usual | No intervention | Prenatal care continues as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder-7 (GAD-7) scale
Anxiety symptoms, scores range from 0-21 with higher scores indicating greater anxiety symptom severity
Measured: 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
Measured: Baseline, 4 weeks, 8 weeks
Treatment Evaluation Inventory Short Form (TEI-SF)
Acceptability, scores range from 9-45 with higher scores indicating greater acceptability
Measured: 8 weeks
Secondary outcomes (1)
Patient Health Questionnaire-9 (PHQ-9)
Depression symptoms, scores range from 0-27 with higher scores indicating greater depression symptom severity
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start15 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Martha Zimmermann, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458698
- Sponsor's protocol ID
- STUDY00001942
- Other IDs
- K23MH137382
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant survey data will be made available.
Publications
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.
PubMed 39494447Zimmermann 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.
PubMed 40642841