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Digital Therapeutic vs Educational App for Depression Among Adolescents | Clinical Trials | Clareo Health

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Digital Therapeutic vs Educational App for Depression Among Adolescents

A Randomized Controlled Trial of a Digital Therapeutic (WB002) and Educational App (ED002) for Depression Among Adolescents

NCT05486611•Woebot Health

View on ClinicalTrials.gov

Summary

The primary aim of this study is to investigate the difference in depression symptoms at 4-weeks across two types of programs for addressing depressive symptoms, including Woebot (WB002) and Digital Education (ED002). The secondary aim of this study is to investigate the difference in anxiety symptoms at 4-weeks across the two programs. The tertiary aim of this study is to evaluate the feasibility, acceptability, and satisfaction of each program.

Eligibility

Age

13 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be 13-17.5 years of age
•2. Be a U.S. Resident
•3. Able to read and write in English
•4. If currently on medication: regular, stable dose of antidepressant medications (e.g., escitalopram/Lexapro, fluoxetine/Prozac) for at least 60 days at screening
•5. If currently receiving psychotherapy: must be in therapy for at least 4 weeks at screening
•6. Own or have regular access to a smartphone (operating systems: Android 6 or later and iOS 13 or later) that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with study app
•7. Available and committed to engage with the program for a 8-week duration and complete assessments
•8. Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
•9. Willingness to provide parent/guardian contact information to provide eConsent and participate in clinical interviews

Exclusion Criteria

•1. PHQ-A score less than 10
•2. Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
•3. Lifetime diagnosis of bipolar disorder
•4. Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g., Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
•5. Current (past year) diagnosis of a substance use disorder
•6. Suicide attempt or suicidal ideation with plan and intent within the past 12 months
•7. Previous Woebot application use
•8. Enrollment of more than one member of the same household

Locations (1)

Woebot Health

San Francisco, California, United States

Key Dates

Start Date

August 9, 2022

Primary Completion Date

October 6, 2022

Completion Date

November 2, 2022

Last Updated

December 5, 2022

Enrollment

ACTUAL participants

Conditions

Depression

Interventions

W-GenZD Mobile Application

DEVICE

Digital Education Application (W-EdZD)

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Digital Therapeutic vs Educational App for Depression Among Adolescents

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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