Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement

NCT06404450 | Terminated

• 1 other identifier: A140673 Ref# 22-10528
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety Symptoms

  as measured by the Generalized Anxiety Disorder-7 (GAD-7) after 3-weeks, 6-weeks, and 10- weeks after enrollment, and at 6 to 8 weeks postpartum. The GAD-7 utilizes a sum score and the total score can range from 0-21, with higher scores indicating greater anxiety severity.

  Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum

Secondary Outcomes (4)

• Pregnancy- Related Anxiety

  Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum

• Stress Symptoms

  Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum

• Depressive Symptoms

  Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum

• Insomnia Symptoms

  Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum

Study Arms (2)

Digital cognitive behavioral therapy (dCBT)

EXPERIMENTAL

The experimental group participants will receive "immediate" access to the Daylight program.

Behavioral: Digital CBT

Waitlist Control

NO INTERVENTION

The waitlist control group participants do not have access to the Daylight program during the study, which lasts from pregnancy to 8-weeks after delivery. However, they will be given access to Daylight after completing the 10-week follow-up survey.

Interventions

Digital CBT BEHAVIORAL

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.

Also known as: Daylight

Digital cognitive behavioral therapy (dCBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• California MediCal participant
• Pregnant, 8-27 weeks gestation by ultrasound
• years of age or older
• English speaking
• th grade level of education or more
• Daily access to web-enabled computer, smart phone, or tablet
• Current elevated anxiety symptoms (score on the seven item Generalized Anxiety Disorder (GAD-7)questionnaire of 10 or more

You may not qualify if:

• Received CBT for anxiety in the last 12-months
• New or changed dose of prescription medication for anxiety, depressive symptoms, or poor sleep in \< 4weeks
• Self-reported diagnosis of schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder, severe cognitive impairment (characterized by experiences like forgetting events, having decreased periods of alertness, decreased social awareness)
• Recent trauma to the head or brain damage
• Serious physical health concerns necessitating surgery or hospitalization in the last 6-months

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Illinois at Urbana-Champaign: collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• California State University, Northridge: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (1)

• Ponting C, Baer RJ, Blackman K, Blebu B, Felder JN, Oltman S, Tabb KM, Jelliffe Pawlowski L. Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 30;14:e70627. doi: 10.2196/70627.

  PMID: 40446294 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Laura Jelliffe Pawlowski, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: July 16, 2024
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)