Randomized Controlled Trial of a Digital Therapeutic Versus Psychoeducation for the Management of Mild to Moderate Depression in Adolescents

Woebot Health1 site in 1 country246 target enrollmentAugust 2, 2021

ConditionsDepression, Teen

Overview

Phase: N/A
Intervention: Not specified
Conditions: Depression, Teen
Sponsor: Woebot Health
Enrollment: 246
Locations: 1
Primary Endpoint: Patient Health Questionnaire (PHQ-8)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.

Registry

clinicaltrials.gov

Start Date

August 2, 2021

End Date

January 4, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Woebot Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adolescents aged 16-17 years old
•Experiencing mild-moderate depression as indicated by a PHQ-8 score between 5-19, inclusive, assessed at screening/baseline
•Has regular access to a smartphone (Android or iOS smartphone with a recent supported operating system) with reliable WiFi access or sufficient data to engage with assigned study arm for the duration of the study
•Available and committed to engage with the program and complete assessments for an 8-week duration
•Able to read and write in English
•U.S. resident
•Regular, stable dose of antidepressant medications for (e.g. escitalopram/Lexapro, fluoxetine/ Prozac) for at least 60 days at screening with no plans to change medication/dose throughout the study
•If currently receiving psychotherapy, then must be in therapy for at least 4 weeks at screening with no changes planned for the duration of the study
•Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions

Exclusion Criteria

•Lifetime diagnosis of a psychotic disorder, including schizophrenia and schizoaffective disorder
•Lifetime diagnosis of bipolar disorder
•Lifetime diagnosis of autistic spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
•Suicidal attempt or ideation with a plan and intent to harm oneself during the last 12 months
•History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
•Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
•Previous Woebot Application use

Outcomes

Primary Outcomes

Patient Health Questionnaire (PHQ-8)

Time Frame: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks

Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.

Secondary Outcomes

Usage Rating Profile Intervention (URPI)(Post-treatment (8 weeks from baseline))
Mood change ratings after CBT skill application(Post-treatment (8 weeks from baseline))
Working Alliance Inventory (WAI-SR)(Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks)
Mental Health Self-Efficacy Scale (MHSE)(Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks)
Number of active application days(Post-treatment (8 weeks from baseline))
Satisfaction ratings of psychoeducational materials(Post-treatment (8 weeks from baseline))
Generalized Anxiety Disorder (GAD-7)(Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks)
Client Satisfaction Questionnaire (CSQ)(Post-treatment (8 weeks from baseline))
Number of application messages sent per week(Post-treatment (8 weeks from baseline))