AnxietyTHRIVENCT06404450
Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement
A study testing Digital CBT in people with Anxiety, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- Digital CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 9 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: Transforming Health and Reducing PerInatal Anxiety Through Virtual Engagement (the HOPE THRIVE STUDY)
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Digital CBT
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital CBTBehavioural
Also called Daylight
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital cognitive behavioral therapy (dCBT) | Experimental | The experimental group participants will receive "immediate" access to the Daylight program. Receives: Behavioral: Digital CBT |
| Waitlist Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Secondary outcomes (4)
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.
Measured: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
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.
Measured: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
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.
Measured: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
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.
Measured: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start16 Jul 2024
- Primary completion9 May 2025
- Study completion9 May 2025
Why it stopped: The trial has experienced accrual difficulties and is halted pending additional funding for study recruitment and operations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, California State University, Northridge
- Responsible party
- Sponsor
- Investigators
- Laura Jelliffe Pawlowski, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404450
- Sponsor's protocol ID
- A140673 Ref# 22-10528
- Acronym
- THRIVE
- Status last verified
- Jun 2025
- First submitted
- 3 May 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ponting C, Baer RJ, Blackman K, Blebu B, Felder JN, Oltman S, Tabb KM, Jelliffe Pawlowski L. Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 30;14:e70627. doi: 10.2196/70627.
PubMed 40446294
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Health and Reducing PerInatal Anxiety Through Virtual Engagement (the HOPE THRIVE STUDY)
- ClinicalTrials.gov ID
- NCT06404450
- Acronym / sponsor ID
- THRIVE / A140673 Ref# 22-10528
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial has experienced accrual difficulties and is halted pending additional funding for study recruitment and operations.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, California State University, Northridge
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital cognitive behavioral therapy (dCBT) | Experimental | Behavioral: Digital CBTThe experimental group participants will receive "immediate" access to the Daylight program. |
| Waitlist Control | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital CBTAlso: DaylightThe 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. | Behavioural | Digital cognitive behavioral therapy (dCBT) |
Primary outcome
Anxiety Symptoms
Time frame: 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.
4 secondary outcomes
Pregnancy- Related Anxiety
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Stress Symptoms
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Depressive Symptoms
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Insomnia Symptoms
Time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
Results and safety
The study was stopped early (reason given: The trial has experienced accrual difficulties and is halted pending additional funding for study recruitment and operations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Derived from this study: PubMed 40446294Ponting C, Baer RJ, Blackman K, Blebu B, Felder JN, Oltman S, Tabb KM, Jelliffe Pawlowski L. Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 30;14:e70627. doi: 10.2196/70627.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Jelliffe Pawlowski, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital CBT in people with Anxiety, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The trial has experienced accrual difficulties and is halted pending additional funding for study recruitment and operations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Symptoms (time frame: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06404450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.