Digital Therapeutic vs Educational App for Depression Among Adolescents

Woebot Health

Status: Terminated

Conditions: Depression

Treatments: Device: W-GenZD Mobile Application; Device: Digital Education Application (W-EdZD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05486611

W-GenZD-004

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

W-GenZD Mobile Application Group

Experimental group

Description:

Participants assigned to the W-GenZD mobile application group will be asked to download and use the W-GenZD mobile application that will provide information and tools through a chatbot (a computer program designed to communicate with users). Participants will be invited to use the mobile application as often as they like during the 4-week treatment period - we will encourage 5 to 10 minutes of daily use.

Treatment:

Device: W-GenZD Mobile Application

Digital Education Application Group

Sham Comparator group

Description:

Participants assigned to the Digital Education mobile app group will be given instructions on how to download and access the application that will provide general health information. A new article will be provided to the participant at a rate of once per week across the 4 weeks (4 articles total) and they will receive a weekly notification when a new article is available. Each article will be available for one week from release date. We expect a target dosage of roughly 30 minutes per week (120 min), which would make it comparable to Woebot (about 5 min per day X 28 days = 140 min).

Treatment:

Device: Digital Education Application (W-EdZD)