Efficacy, Tolerability and Safety of a Smartphone-delivered, Fully Automatic Cognitive Behavioural Therapy Programme for Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Social Phobia Inventory (SPIN)
研究概览
简要总结
The present study is a randomised controlled trial that seeks to investigate the efficacy and safety of the Alena app as a treatment for social anxiety disorder.
详细描述
This will be a 10-week web-based parallel-group unblinded randomised controlled trial with an 8-week intervention period and a 2-week follow-up post-intervention. Participants will be randomly allocated to receive access to the Alena app or to a wait list control group, in a 1:1 ratio. The Alena app primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scored over 30 on the SPIN (indicating at least moderate social anxiety)
- •Aged 18 or over
- •Fluent in English
- •Has access to a smartphone (iOS or Android) and the internet
- •UK resident
排除标准
- •Currently receiving therapy for their mental health
- •Mental health medication has changed (dosage or presence) in the last 8 weeks
- •Scores over 7 on the AUDIT-C and/or yes on either drug dependence question taken from the DUDIT (indicating drug or alcohol abuse)
- •Previous experience with the Alena app through prior studies or user testing
结局指标
主要结局
Change in Social Phobia Inventory (SPIN)
时间窗: Change from baseline SPIN at 8 weeks
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components.
Change in Work and Social Adjustment Scale (WSAS)
时间窗: Change from baseline WSAS at 8 weeks
The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities.
次要结局
- Change in Social Phobia Inventory (SPIN)(Change from SPIN level at the end of the intervention period at 4 weeks later)
- Work and Social Adjustment Scale (WSAS)(At the follow-up point of 4 weeks after the end of the intervention period.)
- Serious adverse events(Within the intervention period of 8 weeks)