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临床试验/NCT05718141
NCT05718141已完成不适用

An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK

University of Bath2 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
346
试验地点
2
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:

  1. 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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Maria Loades

Clinical Psychologist, Reader in Clinical Psychology

University of Bath

研究点 (2)

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