An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Well-being
研究概览
简要总结
The investigators want to understand the impact of a short online single session programme to improve well-being. Therefore, the investigators are investigating a self-help mental health intervention composed of four distinct modules, all designed to be completed within a single, 60-minute online session.Any university student in the UK can take part. Participants are randomly allocated to either:
- Complete the COMET programme (lasting about 60 minutes) and to practice the skills learned over the next few weeks. Participants are asked to fill out online questionnaires (10-15 minutes) at two points in the future: two weeks from baseline, and four weeks from baseline.
Or 2. Complete a few extra online questionnaires (lasting about 20-30 minutes), and fill out brief questionnaires (10-15 minutes) two weeks and four weeks later. After filling out the questionnaires in four weeks time, participants will then have the opportunity to complete the COMET programme (lasting about 60 minutes).
详细描述
The study will use a randomised controlled trial (RCT) design, with a waiting list control (treatment as usual) group who will have the opportunity to access the intervention 4 weeks after randomisation. The intervention is digital and delivered online via Qualtrics. Participants will answer questions before completing the intervention, and at 2-week and 4-week follow-up. The single session intervention is expected to take < 1 hour to complete, with the research study components taking <20 minutes to complete.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The target population for this study are undergraduate and postgraduate students at UK universities. To be eligible to participate, an individual must be: (i) a registered undergraduate or postgraduate student at a university in the UK; and (ii) able to access the internet. Those who cannot access the internet will not be eligible, and neither will those who are under 16 years of age.
排除标准
- 未提供
研究组 & 干预措施
Intervention: COMET-GB
Online single session intervention via qualtrics (any internet connected device) based on cognitive and behavioural principles.
干预措施: COMET-GB (Other)
Waiting List Control
Participants in the control arm will be provided with information about sources of wellbeing support they can access and will also be asked to fill out additional questionnaires at baseline, which will act as a control for time spent completing online activities. These measures are a Symptom Importance Rating Questionnaire, the Chalder Fatigue Questionnaire [32], Pittsburgh Sleep Quality Index [33], Snaith-Hamilton Pleasure Scale [34], Fatigue Associated with Depression Scale [35]. These will not be completed by the intervention group nor reported as main outcomes on the RCT itself, but will be used in separate observational projects.
结局指标
主要结局
Well-being
时间窗: 4 weeks post randomisation
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) - has 14 items that captures participants feelings and thoughts that best describe their experience over the previous 2 weeks using a scale from 1 to 5. Higher scores indicate better wellbeing.
次要结局
- Depressive symptoms(2 weeks, 4 weeks post randomisation)
- Anxiety symptoms(2 weeks, 4 weeks post randomisation)
- Positive and negative affect(2 weeks, 4 weeks post randomisation)
- Well-being(2 weeks post randomisation)
研究者
Dr Maria Loades
Clinical Psychologist, Reader in Clinical Psychology
University of Bath