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Completed

NCT Number: NCT04985331

Digital Therapeutic vs Psychoeducation for 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.

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Key information

Conditions

Depression, Teen Behavior Behavioral Symptoms Depression

Age range

16 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woebot Health

San Francisco, California, 94107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient Health Questionnaire (PHQ-8)

    Time frame: 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 outcomes

  1. Generalized Anxiety Disorder (GAD-7)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Post-treatment (8 weeks from baseline)

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

  5. Usage Rating Profile Intervention (URPI)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Woebot Health

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 2, 2021
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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