Depression, Teen
Conditions
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.
Interventions
DEVICEW-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.
Sponsors
Woebot Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Client Satisfaction Questionnaire (CSQ) | Post-treatment (8 weeks from baseline) | Range from 8 to 32, with higher values indicating higher satisfaction |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed