Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Laura Jelliffe Pawlowski, PhD (ucsf)
Headshot of Laura Jelliffe Pawlowski
Laura Jelliffe Pawlowski

Description

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.

Official Title

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

Details

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.

Keywords

Anxiety, Anxiety Disorders, Digital CBT, Digital cognitive behavioral therapy (dCBT)

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join 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

Location

  • University of California, San Francisco
    San Francisco California 94118 United States

Lead Scientist at University of California Health

  • Laura Jelliffe Pawlowski, PhD (ucsf)
    Dr. Laura Jelliffe-Pawlowski is an Emeritus Professor Epidemiology & Biostatistics and a senior faculty member in the Institute of Global Health Science and with the California Preterm Birth Initiative in the UCSF School of Medicine.

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06404450
Study Type
Interventional
Participants
Expecting 132 study participants
Last Updated