Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Environmental Reward Observation Scale (EROS)
研究概览
简要总结
This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.
详细描述
This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥22 years old
- •Score ≥10 and <20 on the 8-item Patient Health Questionnaire (PHQ-8)
- •Diagnosis of Major Depression
- •Current resident of the USA
- •Oral and written fluency in English
- •Regular access to the internet via a mobile or tablet device using Android (5 or higher) or iOS (13 or higher)
- •Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
排除标准
- •Must not be currently receiving or be expecting to start therapy for depression, anxiety, or sleep during study participation, or have received cognitive behavioral therapy for depression, anxiety, or sleep in the past 12-months
- •If on psychotropic medication, this must be stable for at least 60 days
- •Past or present psychosis, schizophrenia, or bipolar disorder
- •Moderate or greater suicide risk
- •Treatment-resistant depression
- •Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation
- •Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
- •Any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities
- •Other exclusion criteria may apply
结局指标
主要结局
Environmental Reward Observation Scale (EROS)
时间窗: 5 weeks post-randomization
A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities
Patient Health Questionnaire (PHQ-8)
时间窗: 5 weeks post-randomization
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
次要结局
- Patient Health Questionnaire (PHQ-8)(10 weeks post-randomization)
- Montgomery-Åsberg Depression Rating Scale (MADRS)(5 and 10 weeks post-randomization)
- World Health Organization 5-item Wellbeing Index (WHO-5)(Weeks 5 and 10 post-randomization)
- Environmental Reward Observation Scale (EROS)(10 weeks post-randomization)