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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Calm Pilot (K23)
- ClinicalTrials.gov ID
- NCT07458698
- Acronym / sponsor ID
- STUDY00001942
- Conditions
- Perinatal Anxiety, Anxiety Sensitivity, Perinatal Depression
- Keywords
- Perinatal anxiety, Obstetric care, Perinatal mental health, Digital mental health, Engagement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reaching Calm | Experimental | Behavioral: Digital mental health interventionReaching 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. |
| Prenatal care continues as usual | No intervention | –Prenatal care continues as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital mental health interventionAlso: Reaching Calm, Anxiety Sensitivity InterventionReaching 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. | Behavioural | Reaching Calm |
Primary outcome
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
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
Treatment Evaluation Inventory Short Form (TEI-SF)
Time frame: 8 weeks
Acceptability, scores range from 9-45 with higher scores indicating greater acceptability
1 secondary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 39494447Zimmermann 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.
- Background: PubMed 40642841Zimmermann 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.
- Individual participant dataSharing planned: Yes. De-identified participant survey data will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Zimmermann, PhD (617-870-4798, martha.zimmermann1@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 (GAD-7) scale (time frame: Baseline, 4-weeks, and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07458698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.