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

NCT04985331 | Completed

• 1 other identifier: W-GenZD-002
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• Client Satisfaction Questionnaire (CSQ)

  Post-treatment (8 weeks from baseline)

• Usage Rating Profile Intervention (URPI)

  Post-treatment (8 weeks from baseline)

Study Arms (2)

W-GenZD

EXPERIMENTAL

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

Psychoeducation Control

NO INTERVENTION

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.

Interventions

W-GenZD 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.

W-GenZD

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Woebot Health: lead

Study Sites (1)

Woebot Health

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 2, 2021
• Study Start: August 2, 2021
• Primary Completion: December 16, 2021
• Study Completion: January 4, 2022
• Last Updated: January 5, 2022

Record last verified: 2022-01

Locations

US (1)