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Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement

NCT06404450 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-08

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether digital cognitive behavioral therapy (dCBT) can be used to address clinical anxiety in marginalized and low-income pregnant people in California. The main question it aims to answer is:

What is the efficacy of digital cognitive behavioral therapy (dCBTI) for reducing clinical anxiety among marginalized and low-income pregnant people?

Participants will receive digital cognitive behavioral therapy immediately, or 10 weeks after enrollment (i.e., waitlist control). Participants will complete surveys and interviews until 6-8 weeks postpartum.

Conditions

Interventions

BEHAVIORAL

Digital CBT

The digital CBT program is called Daylight (Big Health, Ltd). The program employs a virtual therapist to guide individuals through interactive exercises and animations to facilitate the learning and implementation of CBT techniques. The program focuses on four modules (10-20 minutes each) which address specific CBT principles: stimulus control, applied relaxation, cognitive restructuring (decatastrophizing), and imaginal exposure. Daylight is designed to be self-paced, with the app encouraging users to practice techniques both within the app and in real-life situations on a daily basis. Users receive reminders and motivational messages via emails, push notifications, and text messages tailored to participant progress.

Sponsors & Collaborators

  • University of Illinois at Urbana-Champaign

    collaborator OTHER

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • California State University, Northridge

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Laura Jelliffe Pawlowski, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2025-05-09
Completion
2025-05-09

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06404450 on ClinicalTrials.gov