Effectiveness and Cost-effectiveness of a Fully Self-guided Internet-based Intervention for Shyness and Sub-clinical Social Anxiety Symptoms in the General Population: Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,105
- 试验地点
- 4
- 主要终点
- change in social anxiety symptoms (self-report using SPIN-17 measure)
研究概览
简要总结
The investigators will test the value of an internet self-help package (E-Couch) for alleviating social anxiety symptoms in the general population. The investigators will undertake a trial of about 2000 participants to compare the effect of the E-Couch intervention compared to a wait-list control condition. Over a period of 12 months the investigators will measure the effect of using E-Couch self-help on social anxiety symptoms, as well as on mental wellbeing, and other secondary outcomes including quality of life, depression and general anxiety, and their use of other sources of help.
详细描述
DESIGN The study will involve a large, pragmatic, randomised controlled trial of the internet-based self-directed E-Couch social anxiety module versus a wait-list control condition for the reduction of sub-clinical social anxiety symptoms, among a general population sample recruited using direct-to-consumer advertisements on national websites.
RECRUITMENT Participants in this study will be recruited using advertisements placed on websites such as the NHS website. Individuals expressing an interest in the online advertisement by clicking on a web link will be directed to a University website containing full information on the trial and the opportunity to ask questions of the study team by email or telephone. Participants will be advised in the information sheet that they are free to withdraw at any time without giving a reason and without it affecting their care.
CONSENT Interested participants will be asked to indicate their willingness to participate in the screening and/or the trial by clicking on Yes in response to the online consent questions.
SCREENING Users who provide their consent will be invited to complete screening questions which will determine whether they are eligible for participation in the trial.
INCLUSION AND EXCLUSION Inclusion criteria for this trial include age 18 years and over, resident of England and a score of 13 or more on the SPIN social anxiety measure, and a willingness to provide a working email address and mobile phone number (to respond to a confirmation email and receive reminders). People who are currently receiving therapist-guided treatment for social anxiety disorder will be excluded from participation as will those with a self-reported diagnosis of bipolar disorder or schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Aged 18 or over
- •Resident in England
- •Willing to provide email address and mobile telephone number
- •Able to use a web-based intervention provided in written English
- •SPIN score 13 or more (to include those with subclinical symptoms)
排除标准
- •Aged under 18
- •Not resident in England
- •Unwilling or unable to provide email address and mobile telephone number
- •Unable to use a web-based intervention provided in written English
- •SPIN score <13
- •Self-reported history of psychosis (schizophrenia or bipolar affective disorder)
- •Receiving therapist-guided support for social anxiety disorder (self-reported)
研究组 & 干预措施
Intervention
The E-Couch self-help social anxiety module which is based on cognitive behavioural therapy principles. This module contains a literacy section and 5 toolkits comprising exposure practice, cognitive restructuring (modifying your thinking), attention practice, social skills training and relaxation. E-Couch is designed to be completed at the participant's own pace. It is free to use, browser-based and widely accessible on a range of connected devices.
干预措施: E-Couch (Behavioral)
Control
Wait list control (WLC)
结局指标
主要结局
change in social anxiety symptoms (self-report using SPIN-17 measure)
时间窗: change from baseline to 6 weeks
self-report social anxiety symptoms using SPIN-17 measure
次要结局
- time off work or study (self-reported time off work or study)-Used for health economic evaluation.(12 months)
- mental wellbeing (self-report WEMWBS measure)(6 weeks, 3 months, 6 months, 12 months)
- depression (self-report CES-D measure)(6 weeks, 3 months, 6 months, 12 months)
- quality of life (using SF36 measure)(6 weeks, 3 months, 6 months, 12 months)
- social anxiety symptoms (fear of negative evaluation) (self-report using BFNE-S measure)(6 weeks, 3 months, 6 months, 12 months)
- social anxiety symptoms (self-report using SPIN-17 measure) at secondary time points(3 months, 6 months, 12 months)
- use of health services (self-reported use of health services)- used for Health economic evaluation.(12 months)