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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Teen

Intervention / Treatment
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* Device: W-GenZD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: W-GenZD<br>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<br>* 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.<br>|
| No Intervention: Psychoeducation Control<br>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?
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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 |
| --- | --- | --- |
| 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 | 
| Client Satisfaction Questionnaire (CSQ) | Range from 8 to 32, with higher values indicating higher satisfaction | Post-treatment (8 weeks from baseline) | 
| 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) |