Digital Therapeutic vs Psychoeducation for Management of Mild to Moderate Depression in Adolescents

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

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.

Study Overview

• Status: Completed
• Conditions: Depression, Teen
• Intervention / Treatment: Device: W-GenZD

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Woebot Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: W-GenZD; W-GenZD is powered by natural language processing and machine learning techniques, the brief, self-guided intervention draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT-A) and some 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 medical application is designed to be targeted, relevant, tailored, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.	Device: W-GenZD; W-GenZD is a 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.
NO_INTERVENTION: Psychoeducation Control; The control for this study is the scheduled delivery of digital psychoeducational files (PDFs). The PDFs were selected to provide information on depression, anxiety and stress, as well as outline common coping skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-8)	Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ)	Range from 8 to 32, with higher values indicating higher satisfaction	Post-treatment (8 weeks from baseline)
Generalized Anxiety Disorder (GAD-7)	Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.	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
Working Alliance Inventory (WAI-SR)	Therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Scores range from 5-20, with higher scores indicating greater alliance.	Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks
Mental Health Self-Efficacy Scale (MHSE)	Assesses confidence in managing stress, depression, and anxiety. Range is 10 to 60, with higher scores indicating more self-efficacy.	Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Usage Rating Profile Intervention (URPI)	Measurement of feasibility and acceptability. Scores range from 6-36, with higher scores indicating greater feasibility and acceptability.	Post-treatment (8 weeks from baseline)
Number of active application days	Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization.	Post-treatment (8 weeks from baseline)
Number of application messages sent per week	Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization.	Post-treatment (8 weeks from baseline)
Satisfaction ratings of psychoeducational materials	Satisfaction metrics in the total number of 'Thumbs up' (likes) or 'Thumbs down' (dislikes) will be collected during the study to provide quantitative data regarding satisfaction with program content.	Post-treatment (8 weeks from baseline)
Mood change ratings after CBT skill application	Satisfaction metrics in the total number of mood change ratings of 'same', 'better', or 'worse, after learning a CBT skill application will be collected during the study to provide quantitative data regarding satisfaction with content.	Post-treatment (8 weeks from baseline)

Collaborators and Investigators

• Sponsor: Woebot Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2021
• Primary Completion (ACTUAL): December 16, 2021
• Study Completion (ACTUAL): January 4, 2022

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (ACTUAL): August 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: W-GenZD-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No