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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| W-GenZD | Experimental | 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. |
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| Psychoeducation Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Working Alliance Inventory (WAI-SR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woebot Health | San Francisco | California | 94107 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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 |
| 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 |
| Client Satisfaction Questionnaire (CSQ) | Range from 8 to 32, with higher values indicating higher satisfaction | 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. | 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. | 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. | 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. | 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. | Post-treatment (8 weeks from baseline) |