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

Depression, Teen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04985331
• Other study ID #: W-GenZD-002
• Status: Completed
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: January 4, 2022

Study information

• Verified date: January 2022
• Source: Woebot Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: January 4, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Teen
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Woebot Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Woebot Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Client Satisfaction Questionnaire (CSQ)	Range from 8 to 32, with higher values indicating higher satisfaction	Post-treatment (8 weeks from baseline)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)