Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement

Not Applicable

Suspended

• Conditions: Anxiety
• Interventions: Behavioral: Digital CBT

• Registration Number: NCT06404450
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-08
• Study Start: 2024-07-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-05-08
• Study Completion: 2025-05-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 132

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital cognitive behavioral therapy (dCBT)	Digital CBT	The experimental group participants will receive "immediate" access to the Daylight program.

Primary Outcome Measures

Name	Time	Method
Anxiety Symptoms	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Stress Symptoms	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum	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.
Depressive Symptoms	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum	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.
Insomnia Symptoms	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum	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.
Pregnancy- Related Anxiety	Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States