A Randomized Controlled Trial of a Digital Therapeutic (WB002) and Educational App (ED002) for Depression Among Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire for Teens (PHQ-A)
研究概览
简要总结
The primary aim of this study is to investigate the difference in depression symptoms at 4-weeks across two types of programs for addressing depressive symptoms, including Woebot (WB002) and Digital Education (ED002). The secondary aim of this study is to investigate the difference in anxiety symptoms at 4-weeks across the two programs. The tertiary aim of this study is to evaluate the feasibility, acceptability, and satisfaction of each program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 13-17.5 years of age
- •Be a U.S. Resident
- •Able to read and write in English
- •If currently on medication: regular, stable dose of antidepressant medications (e.g., escitalopram/Lexapro, fluoxetine/Prozac) for at least 60 days at screening
- •If currently receiving psychotherapy: must be in therapy for at least 4 weeks at screening
- •Own or have regular access to a smartphone (operating systems: Android 6 or later and iOS 13 or later) that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with study app
- •Available and committed to engage with the program for a 8-week duration and complete assessments
- •Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
- •Willingness to provide parent/guardian contact information to provide eConsent and participate in clinical interviews
排除标准
- •PHQ-A score less than 10
- •Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- •Lifetime diagnosis of bipolar disorder
- •Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g., Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
- •Current (past year) diagnosis of a substance use disorder
- •Suicide attempt or suicidal ideation with plan and intent within the past 12 months
- •Previous Woebot application use
- •Enrollment of more than one member of the same household
研究组 & 干预措施
W-GenZD Mobile Application Group
Participants assigned to the W-GenZD mobile application group will be asked to download and use the W-GenZD mobile application that will provide information and tools through a chatbot (a computer program designed to communicate with users). Participants will be invited to use the mobile application as often as they like during the 4-week treatment period - we will encourage 5 to 10 minutes of daily use.
干预措施: W-GenZD Mobile Application (Device)
Digital Education Application Group
Participants assigned to the Digital Education mobile app group will be given instructions on how to download and access the application that will provide general health information. A new article will be provided to the participant at a rate of once per week across the 4 weeks (4 articles total) and they will receive a weekly notification when a new article is available. Each article will be available for one week from release date. We expect a target dosage of roughly 30 minutes per week (120 min), which would make it comparable to Woebot (about 5 min per day X 28 days = 140 min).
干预措施: Digital Education Application (W-EdZD) (Device)
结局指标
主要结局
Patient Health Questionnaire for Teens (PHQ-A)
时间窗: Change from Screening to Mid-treatment at 2 weeks; Change from Screening to Post-treatment at 4 weeks; Change from Screening to Follow-up at 6 and 8 weeks
Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess mood and anxiety symptoms respectively. The PHQ-8 excludes an item assessing suicidality. Total score between 0-27, where higher scores indicate greater levels of depression.
次要结局
- Client Satisfaction Questionnaire (CSQ-8)(Post-treatment at 4 weeks)
- Children's Depression Rating Scale-Revised (CDRS-R)(Change from Baseline to Post-treatment at 4 weeks)
- General Anxiety Disorder Questionnaire (GAD-7)(Change from Baseline to Mid-treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 6 and 8 weeks)
- Usage Rating Profile - Intervention (URPI)-Feasibility(Post-treatment at 4 weeks)
- CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE (CRAFFT)(Baseline)
- Woebot Reflection Questionnaire (WRQ)(Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks)
- PROMIS Pediatric Global Health (PGH-7)(Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks)
- Working Alliance Inventory - Short Revised (WAI-SR)(Day 4; Change from Day 4 to Post-treatment at 4 weeks)
- Alexithymia Questionnaire for Children (AQC)(Change from Baseline to Day 4; Change from Baseline to Post-treatment at 4 weeks)
- Usage Rating Profile - Intervention (URPI)-Acceptability(Post-treatment at 4 weeks)
- Cognitive Flexibility Inventory (CFI)(Change from Baseline to Post-treatment at 4 weeks)