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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
246
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.
Woebot Health
San Francisco, California, United States
Patient Health Questionnaire (PHQ-8)
Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.
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
Generalized Anxiety Disorder (GAD-7)
Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.
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
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.
Time frame: Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks
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.
Time frame: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Client Satisfaction Questionnaire (CSQ)
Range from 8 to 32, with higher values indicating higher satisfaction
Time frame: Post-treatment (8 weeks from baseline)
Usage Rating Profile Intervention (URPI)
Measurement of feasibility and acceptability. Scores range from 6-36, with higher scores indicating greater feasibility and acceptability.
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Time frame: Post-treatment (8 weeks from baseline)
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.
Time frame: Post-treatment (8 weeks from baseline)
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.
Time frame: Post-treatment (8 weeks from baseline)
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.
Time frame: Post-treatment (8 weeks from baseline)
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.
Time frame: Post-treatment (8 weeks from baseline)