Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Disorder Questionnaire (GAD-7)
研究概览
简要总结
This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
详细描述
This study aims to examine the effectiveness of app-based digital CBT for anxiety compared to psychoeducation in individuals with a diagnosis of Generalized Anxiety Disorder. The primary outcomes are anxiety symptom reduction and remission after 10 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
- Double (Investigator, Outcomes Assessor)
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 ≥15 on the 7-item Generalized Anxiety Disorder questionnaire (GAD-7)
- •Diagnosis of GAD
- •Current resident of the USA
- •Oral and written fluency in English
- •Regular access to the internet via a mobile or tablet device using Android ( 8 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 psychological treatment for anxiety during study participation, or have previously received Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for anxiety in the past 6-months (self-report)
- •If on psychotropic medication, this must be stable for at least 60 days
- •Past or present psychosis, schizophrenia, or bipolar disorder, or current OCD
- •Past 12 months alcohol or substance use disorder of moderate or greater severity
- •Moderate or greater suicide risk
- •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
结局指标
主要结局
Generalized Anxiety Disorder Questionnaire (GAD-7)
时间窗: 10 weeks post-randomization
Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity
Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
时间窗: 10 weeks post-randomization
A single-item measure scored between 1 and 7 where scores of 1 or 2 indicates clinically significant improvement, a score of 3 indicates mild improvement, a score of 4 indicates no change, and scores from 5 to 7 indicate deterioration
次要结局
- Clinical Global Impression - Severity (CGI-S)(Weeks 10 and 24 post-randomization)
- Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)(24 weeks post-randomization)
- Sleep Condition Indicator (SCI-8)(Weeks 10 and 24 post-randomization)
- Generalized Anxiety Disorder Questionnaire (GAD-7)(6 and 24 weeks post-randomization)
- Patient Health Questionnaire (PHQ-8)(Weeks 10 and 24 post-randomization)