Digital Therapeutic vs Psychoeducation for Management of Mild to Moderate Depression in Adolescents
- Conditions
- Depression, Teen
- Interventions
- Device: W-GenZD
- Registration Number
- NCT04985331
- Lead Sponsor
- Woebot Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description W-GenZD 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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.
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.
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.
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.
Client Satisfaction Questionnaire (CSQ) Post-treatment (8 weeks from baseline) Range from 8 to 32, with higher values indicating higher satisfaction
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.
Trial Locations
- Locations (1)
Woebot Health
🇺🇸San Francisco, California, United States