Digital Therapeutic vs Educational App for Depression Among Adolescents

NCT05486611 | Terminated

• 1 other identifier: W-GenZD-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Mental Health; Adolescent; Digital Therapeutic; Chatbot; Mental Health App

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire for Teens (PHQ-A)

  Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess mood and anxiety symptoms respectively. The PHQ-8 excludes an item assessing suicidality. Total score between 0-27, where higher scores indicate greater levels of depression.

  Change from Screening to Mid-treatment at 2 weeks; Change from Screening to Post-treatment at 4 weeks; Change from Screening to Follow-up at 6 and 8 weeks

Secondary Outcomes (11)

• General Anxiety Disorder Questionnaire (GAD-7)

  Change from Baseline to Mid-treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 6 and 8 weeks

• Children's Depression Rating Scale-Revised (CDRS-R)

  Change from Baseline to Post-treatment at 4 weeks

• PROMIS Pediatric Global Health (PGH-7)

  Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks

• Client Satisfaction Questionnaire (CSQ-8)

  Post-treatment at 4 weeks

• Usage Rating Profile - Intervention (URPI)-Feasibility

  Post-treatment at 4 weeks

Study Arms (2)

W-GenZD Mobile Application Group

EXPERIMENTAL

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.

Device: W-GenZD Mobile Application

Digital Education Application Group

SHAM COMPARATOR

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).

Device: Digital Education Application (W-EdZD)

Interventions

W-GenZD Mobile Application 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.

W-GenZD Mobile Application Group

Digital Education Application (W-EdZD) 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.

Digital Education Application Group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be 13-17.5 years of age
• Be a U.S. Resident
• Able to read and write in English
• If currently on medication: regular, stable dose of antidepressant medications (e.g., escitalopram/Lexapro, fluoxetine/Prozac) for at least 60 days at screening
• If currently receiving psychotherapy: must be in therapy for at least 4 weeks at screening
• 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
• Available and committed to engage with the program for a 8-week duration and complete assessments
• Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
• Willingness to provide parent/guardian contact information to provide eConsent and participate in clinical interviews

You may not qualify if:

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

Sponsors & Collaborators

• Woebot Health: lead

Study Sites (1)

Woebot Health

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Athena Robinson, PhD

  Woebot Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: August 9, 2022
• Primary Completion: October 6, 2022
• Study Completion: November 2, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Locations

US (1)