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.

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