Anxiety & Depression Association of America

Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement

Purpose

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.

Condition

Anxiety

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

California MediCal participant - Pregnant, 8-27 weeks gestation by ultrasound - 18-years of age or older - English speaking - 9th 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

Exclusion Criteria

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Digital cognitive behavioral therapy (dCBT)	The experimental group participants will receive "immediate" access to the Daylight program.	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. Other names: Daylight
No Intervention Waitlist Control	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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of California, San Francisco

Study Contact

Laura Jelliffe Pawlowski, PhD
415-476-6132
Laura.Jelliffe@ucsf.edu

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.