NCT06404450

Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement

Transforming Health and Reducing PerInatal Anxiety Through Virtual Engagement (the HOPE THRIVE STUDY)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Although therapist-delivered cognitive behavioral therapy (CBT) has been shown to be effective for treating clinical anxiety in non-marginalized pregnant populations, barriers to access exist among pregnant people (e.g., long waitlists, childcare issues, limited appointment windows). Recent innovations have focused on addressing barriers to CBT by adapting it for automated, digital delivery. Digital CBT (dCBT) has been shown to be effective for treating clinical anxiety in mostly White, higher socioeconomic status, pregnant, and non-pregnant populations. Person-centered adaptations of dCBT are likely needed to maximize access in marginalized and low-income pregnant people. This study addresses the critical need to evaluate whether dCBT can be used to address clinical anxiety in marginalized and low-income pregnant people in California.

Conditions

• Anxiety

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-16
• Primary completion: 2025-05-09
• Completion: 2025-05-09
• First posted: 2024-05-08
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States