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

Sponsor
Woebot Labs, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04985331
Collaborator
(none)
246
1
2
5.1
48.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: W-GenZD
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
246 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of a Digital Therapeutic Versus Psychoeducation for the Management of Mild to Moderate Depression in Adolescents
Actual Study Start Date :
Aug 2, 2021
Actual Primary Completion Date :
Dec 16, 2021
Actual Study Completion Date :
Jan 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire (PHQ-8) [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]

    Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.

Secondary Outcome Measures

  1. 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]

    Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.

  2. Working Alliance Inventory (WAI-SR) [Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks]

    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.

  3. 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]

    Assesses confidence in managing stress, depression, and anxiety. Range is 10 to 60, with higher scores indicating more self-efficacy.

  4. Client Satisfaction Questionnaire (CSQ) [Post-treatment (8 weeks from baseline)]

    Range from 8 to 32, with higher values indicating higher satisfaction

  5. Usage Rating Profile Intervention (URPI) [Post-treatment (8 weeks from baseline)]

    Measurement of feasibility and acceptability. Scores range from 6-36, with higher scores indicating greater feasibility and acceptability.

  6. Number of active application days [Post-treatment (8 weeks from baseline)]

    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.

  7. Number of application messages sent per week [Post-treatment (8 weeks from baseline)]

    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.

  8. Satisfaction ratings of psychoeducational materials [Post-treatment (8 weeks from baseline)]

    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.

  9. Mood change ratings after CBT skill application [Post-treatment (8 weeks from baseline)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Woebot Health San Francisco California United States 94107

Sponsors and Collaborators

  • Woebot Labs, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Woebot Labs, Inc.
ClinicalTrials.gov Identifier:
NCT04985331
Other Study ID Numbers:
  • W-GenZD-002
First Posted:
Aug 2, 2021
Last Update Posted:
Jan 5, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2022