Recruiting

Reaching Calm

Sponsor:

University of Massachusetts, Worcester

Code:

NCT07458698

Conditions

Perinatal Anxiety

Anxiety Sensitivity

Perinatal Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital mental health intervention

Study Details

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.

Conditions

Perinatal Anxiety

Anxiety Sensitivity

Perinatal Depression

Study ID

NCT07458698

Start date

Aug 15, 2026

Status verified date

Sep, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

no intervention: Prenatal care continues as usual

Prenatal care continues as usual

Interventions

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.

Primary outcome measure

  • Generalized Anxiety Disorder-7 (GAD-7) scale [ Time Frame: Baseline, 4-weeks, and 8 weeks ]
  • Anxiety Sensitivity Index-3 (ASI-3) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Treatment Evaluation Inventory Short Form (TEI-SF) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Martha Zimmermann, PhD

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

Reaching Calm Study Team

978-732-4583RCAppStudy@umassmed.edu

Locations

UMass Memorial Medical Group - Montachusett Women's Health

Recruiting

Leominster, Massachusetts, United States, 01453

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • Perinatal anxiety
  • Obstetric care
  • Perinatal mental health
  • Digital mental health
  • Engagement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-09-17.