NCT04985331已完成不适用
Randomized Controlled Trial of a Digital Therapeutic Versus Psychoeducation for the Management of Mild to Moderate Depression in Adolescents
Woebot Health2 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2021年8月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-8)
研究概览
简要总结
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.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient Health Questionnaire (PHQ-8)
时间窗: 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.
次要结局
- Usage Rating Profile Intervention (URPI)(Post-treatment (8 weeks from baseline))
- Mood change ratings after CBT skill application(Post-treatment (8 weeks from baseline))
- Working Alliance Inventory (WAI-SR)(Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks)
- 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)
- Number of active application days(Post-treatment (8 weeks from baseline))
- Satisfaction ratings of psychoeducational materials(Post-treatment (8 weeks from baseline))
- 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)
- Client Satisfaction Questionnaire (CSQ)(Post-treatment (8 weeks from baseline))
- Number of application messages sent per week(Post-treatment (8 weeks from baseline))
研究者
研究点 (2)
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