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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
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.
University of California, San Francisco
San Francisco, California, United States
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.
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Pregnancy- Related Anxiety
as measured by the Pregnancy Related Anxiety Scale (PRAS) after 3-weeks, 6-weeks, and 10-weeks after enrollment, and at 6 to 8 weeks postpartum. The PRAS utilizes a sum score and the total score can range from 4 to 40, with higher scores indicating more pregnancy-specific anxiety.
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Stress Symptoms
as measured by the Perceived Stress Scale (PSS) after 3-weeks, 6-weeks, and 10-weeks after enrollment, and at 6 to 8 weeks postpartum.The PSS utilizes a sum score and total scores can range from 0-40, with higher scores indicating greater perceived stress.
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Depressive Symptoms
as measured by the Patient Health Questionnaire-9 (PHQ-9) after 3-weeks, 6-weeks, and 10-weeks after enrollment, and at 6 to 8 weeks postpartum. The PHQ-9 utilizes a sum score and total scores can range from 0-27, with higher scores indicating greater depression severity.
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Insomnia Symptoms
as measured by the Insomnia Severity Index (ISI) after 3-weeks, 6-weeks, and 10-weeks after enrollment, and at 6 to 8 weeks postpartum. The ISI utilizes a sum score and total scores can range from 0-28, with higher scores indicating greater insomnia severity.
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
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