The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Questionnaire assessing satisfaction, helpfulness and ease of use
研究概览
简要总结
The present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the Alena CBT programme as a treatment for social anxiety disorder.
详细描述
This is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week intervention period and a 2-week follow-up post intervention. Participants are randomly allocated to receive access to the Alena CBT programme or to a wait list control group, in a 1:1 ratio. The programme consists of CBT-based therapy for social anxiety based on the Clark and Wells model.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged between 18 and 35 years old (inclusive)
- •located in the UK
- •fluent in English
- •comfortable taking part in a study that included deception (due to the nature of the cognitive assessments)
- •had an iPhone and daily access to an internet connection
- •scored over 30 on the Social Phobia Inventory (SPIN; indicating at least moderate social anxiety).
排除标准
- •currently undergoing any mental health therapy
- •changed the usual mental health medication or dosage within the past eight weeks
- •scored eight or above on the Alcohol Use Disorders Identification Test for consumption (AUDIT-C; indicating higher risk of alcohol dependence)
- •scored two or above on the adapted drug questions (indicating higher risk of drug dependence)
- •had previously participated in scientific studies or user research undertaken by Alena
结局指标
主要结局
Questionnaire assessing satisfaction, helpfulness and ease of use
时间窗: Week 6 (2-week follow-up post-intervention)
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Questionnaires assessing negative effects from using the app and adverse health events
时间窗: Week 6 (2-week follow-up post-intervention)
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
次要结局
- Work and Social Adjustment Scale (WSAS)(Week 6 (2-week follow-up post-intervention))
- Social phobia inventory (SPIN)(Week 6 (2-week follow-up post-intervention))