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Cognitive Behavioral Therapy
Online Therapy for Anxiety During Pregnancy (THRIVE Trial)
N/A
Recruiting
Led By Laura Jelliffe Pawlowski, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-years of age or older
Be older than 18 years old
Must not have
Received CBT for anxiety in the last 12 months
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3, 6, and 10-weeks after the program start, and baseline to 6-8 weeks postpartum
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if an online therapy program can help reduce anxiety in pregnant individuals from marginalized and low-income backgrounds in California. Participants will either start the therapy immediately or after 10 weeks. They
Who is the study for?
This trial is for low-income, marginalized pregnant individuals in California experiencing clinical anxiety. Participants will be enrolled to receive digital cognitive behavioral therapy (dCBT) either immediately or after a 10-week waiting period and will be monitored until about 2 months after giving birth.
What is being tested?
The study is testing the effectiveness of dCBT in reducing anxiety during pregnancy. It's set up so some get the therapy right away, while others wait for 10 weeks, serving as a control group to measure the treatment's impact.
What are the potential side effects?
Since this trial involves digital cognitive behavioral therapy, there are no direct physical side effects like with medication. However, participants may experience emotional discomfort discussing personal issues during therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have undergone cognitive behavioral therapy for anxiety in the past year.
Select...
I have been diagnosed with a mental health or cognitive condition.
Select...
I haven't needed surgery or been hospitalized for a serious health issue in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3, 6, and 10-weeks after the program start, and baseline to 6-8 weeks postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3, 6, and 10-weeks after the program start, and baseline to 6-8 weeks postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety Symptoms
Secondary study objectives
Depressive Symptoms
Insomnia Symptoms
Pregnancy- Related Anxiety
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital cognitive behavioral therapy (dCBT)Experimental Treatment1 Intervention
The experimental group participants will receive "immediate" access to the Daylight program.
Group II: Waitlist ControlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital CBT
2023
N/A
~70
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,573 Previous Clinical Trials
15,175,404 Total Patients Enrolled
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14,792 Patients Enrolled for Anxiety
University of Illinois at Urbana-ChampaignOTHER
197 Previous Clinical Trials
38,143 Total Patients Enrolled
1 Trials studying Anxiety
300 Patients Enrolled for Anxiety
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterOTHER
104 Previous Clinical Trials
46,451 Total Patients Enrolled
1 Trials studying Anxiety
12 Patients Enrolled for Anxiety
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