Health TrialsbyHealthPanel

Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

ConditionsPerinatal AnxietyAnxiety SensitivityPerinatal Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Massachusetts, Worcester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Not pregnant

Unable to participate in 60-minute interview

Unwilling to be audio recorded

GAD-7 <5, or GAD-7≥15

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital mental health intervention

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Reaching CalmExperimental treatment 1 intervention
Group B: Prenatal care continues as usualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Generalized Anxiety Disorder-7 (GAD-7) scale

Anxiety symptoms, scores range from 0-21 with higher scores indicating greater anxiety symptom severity

Time frame
Baseline, 4-weeks, and 8 weeks
2

Anxiety Sensitivity Index-3 (ASI-3)

Anxiety sensitivity, scores range from 0-72 with higher scores indicating greater anxiety sensitivity

Time frame
Baseline, 4 weeks, 8 weeks
3

Treatment Evaluation Inventory Short Form (TEI-SF)

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

Time frame
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

Time frame
Baseline, 4 weeks, 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
Apply now