Acceptability and Effectiveness of an mHealth Intervention to Provide Cognitive Behavioral Therapy (CBT) for Adolescents With Depression/Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
Washington University will evaluate the acceptability and effectiveness of a mobile health (mHealth) intervention to provide cognitive behavioral therapy for adolescents with depression.
详细描述
In this pilot project, Washington University will start to evaluate CBot-A, a promising mHealth therapeutic intervention designed to deliver cognitive behavioral therapy (CBT) through an app on a phone or other mobile device. The evaluation will include a randomized trial among 40 adolescents diagnosed with depression and/or anxiety and will assess if CBot-A is usable by teens and likely to provide benefit, and acceptable to adolescents.
The primary outcome of depression and anxiety symptoms in adolescents will be assessed at 1 month and 3 months to check for any changes.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents 12-17 years of age and diagnosed with a major depressive disorder (MDD) and/or generalized anxiety disorder by their primary care provider within the past 3 months.
排除标准
- •Adolescents with the following conditions (identified by parental report) will be excluded:
- •Participated in formal CBT within the past 12-months
- •Diagnosed with severe depression
- •Diagnosed with the following anxiety disorders - obsessive-compulsive disorders, post-traumatic stress disorder, panic disorder, or specific phobias
- •A psychiatric hospitalization in the previous month
- •With significant comorbidities such that the PCP would refer to a mental health professional for treatment, including those with a substance use disorder or a psychotic illness.
- •Are not accompanied by a guardian to the diagnostic visit
- •Without access to a mobile device (cell phone or tablet) for regular use
- •Unable to read and write English
- •Participants may also be excluded at the discretion of the PI.
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: 1 month
The PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms
次要结局
- General Anxiety Disorder-7 (GAD-7)(1 month)
研究者
Jane Garbutt, MD
Professor of Medicine and Pediatrics
Washington University School of Medicine