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

Woebot Health1 site in 1 country6 target enrollmentAugust 9, 2022

ConditionsDepression

Overview

Phase: N/A
Intervention: Not specified
Conditions: Depression
Sponsor: Woebot Health
Enrollment: 6
Locations: 1
Primary Endpoint: Patient Health Questionnaire for Teens (PHQ-A)
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 9, 2022

End Date

November 2, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Woebot Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Patient Health Questionnaire for Teens (PHQ-A)

Time Frame: 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

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.

Secondary Outcomes

Children's Depression Rating Scale-Revised (CDRS-R)(Change from Baseline to Post-treatment at 4 weeks)
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)
Usage Rating Profile - Intervention (URPI)-Feasibility(Post-treatment at 4 weeks)
CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE (CRAFFT)(Baseline)
Woebot Reflection Questionnaire (WRQ)(Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 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)
Working Alliance Inventory - Short Revised (WAI-SR)(Day 4; Change from Day 4 to Post-treatment at 4 weeks)
Alexithymia Questionnaire for Children (AQC)(Change from Baseline to Day 4; Change from Baseline to Post-treatment at 4 weeks)
Usage Rating Profile - Intervention (URPI)-Acceptability(Post-treatment at 4 weeks)
Cognitive Flexibility Inventory (CFI)(Change from Baseline to Post-treatment at 4 weeks)