Clinical trial NCT06404450: Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement
Official title: Transforming Health and Reducing PerInatal Anxiety Through Virtual Engagement (the HOPE THRIVE STUDY)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Illinois at Urbana-Champaign
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: California State University, Northridge
First posted: 2024-05-08
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety Symptoms
timeFrame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Secondary outcomes:
measure: Pregnancy- Related Anxiety
timeFrame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
measure: Stress Symptoms
timeFrame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
measure: Depressive Symptoms
timeFrame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
measure: Insomnia Symptoms
timeFrame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Laura Jelliffe Pawlowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: