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

NCT ID: NCT04985331

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2022-01-04

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.

Conditions

Depression, Teen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

W-GenZD

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woebot Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Woebot Health

San Francisco, California, United States

Countries

United States

Other Identifiers

W-GenZD-002

Identifier Type: -

Identifier Source: org_study_id