Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement (THRIVE)

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Anxiety

Treatments: Behavioral: Digital CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT06404450

A140673 Ref# 22-10528

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Digital cognitive behavioral therapy (dCBT)

Experimental group

Description:

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

Treatment:

Behavioral: Digital CBT

Waitlist Control

No Intervention group

Description:

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.