Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement

Anxiety Clinical Trial

— THRIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404450
• Other study ID #: A140673 Ref# 22-10528
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Laura Jelliffe Pawlowski, PhD
• Phone: 415-476-6132
• Email: Laura.Jelliffe[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	California State University, Northridge, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Secondary	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.	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Secondary	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.	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Secondary	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.	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum