Digital Therapeutic vs Educational App for Depression Among Adolescents

NCT ID: NCT05486611

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2022-11-02

Brief 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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

W-GenZD Mobile Application Group

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.

Group Type: EXPERIMENTAL

W-GenZD Mobile Application

Intervention Type: DEVICE

W-GenZD is a mobile application program that delivers evidence-based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief "conversations" with a fully automated relational agent called Woebot. It is a brief, self-guided 4 week-intervention that draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy for adolescents (IPT-A), and elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile application is designed to be targeted, relevant, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.

Digital Education Application Group

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).

Group Type: SHAM_COMPARATOR

Digital Education Application (W-EdZD)

Intervention Type: DEVICE

Digital Education will be available to the participant via the 'Quest GenZ' smartphone application but will be devoid of active elements included in WB002. We will source this material from kidshealth.org, which is supported by Nemours Children's Health. We have received permission to use their content.

The materials are written at an 8th grade reading level and will include general health (e.g., food plate guide, caffeine, online safety, study skills) articles. 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.

Interventions

W-GenZD Mobile Application

W-GenZD is a mobile application program that delivers evidence-based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief "conversations" with a fully automated relational agent called Woebot. It is a brief, self-guided 4 week-intervention that draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy for adolescents (IPT-A), and elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile application is designed to be targeted, relevant, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.

Intervention Type: DEVICE

Digital Education Application (W-EdZD)

Digital Education will be available to the participant via the 'Quest GenZ' smartphone application but will be devoid of active elements included in WB002. We will source this material from kidshealth.org, which is supported by Nemours Children's Health. We have received permission to use their content.

The materials are written at an 8th grade reading level and will include general health (e.g., food plate guide, caffeine, online safety, study skills) articles. 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woebot Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athena Robinson, PhD

Role: PRINCIPAL_INVESTIGATOR

Woebot Health

Locations

Woebot Health

San Francisco, California, United States

Countries

United States

Other Identifiers

W-GenZD-004

Identifier Type: -

Identifier Source: org_study_id