A Randomised Controlled Trial of a Mindfulness-based Cognitive Therapy Self-help Intervention for UK National Health Service Employees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Stress
研究概览
简要总结
This study examines whether a mindfulness-based self-help book is effective at reducing healthcare workers' levels of stress and improving their wellbeing.
详细描述
This study is a randomised controlled trial (RCT) examining the efficacy of a mindfulness-based cognitive therapy self-help book ('Mindfulness: A practice guide to finding peace in a frantic world') relative to a wait-list control, in healthcare staff. It builds on a previous pilot RCT (http://www.isrctn.com/ISRCTN16486066). A battery of measures will be administered at baseline (week 0), post-intervention (week 9) and follow-up (week 21). This trial is designed to test the following hypotheses.
Primary Hypothesis
-Mindfulness-based cognitive therapy self-help (MBCT-SH) participants, in comparison to waitlist control participants, will show a reduction in symptoms of stress by the end of MBCT-SH (week 9).
Secondary Hypotheses
- The improvement detailed in the primary hypothesis will be maintained at a follow-up 12 weeks after the end of the MBCT-SH (week 21).
- MBCT-SH participants, in comparison to waitlist control participants, will show improvements in mindfulness, other-compassion, self-compassion, anxiety, depression, burnout and mental well-being by the end of MBCT-SH (week 9), and these improvements will be maintained at a follow-up 12 weeks after the end of the MBCT-SH (week 21).
- MBCT-SH participants, in comparison to waitlist control participants, will show a reduction in the number of sickness absence days from the three months preceding the intervention to the three months following the intervention.
- Increases in self-compassion and mindfulness from week 0 to week 9, will mediate the effects of MBCT-SH (relative to waitlist control) on levels of stress, depression, anxiety, wellbeing and burnout.
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
- Single (Investigator)
盲法说明
Random allocation of participants to arms will be conducted by a statistician independent of the study.
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
- •Being currently employed by Sussex Partnership NHS Foundation Trust (in the UK) in a role or roles that involve direct delivery of healthcare.
- •Having at least one day per week of direct contact with UK National Health Service service users.
- •Agreeing to refrain from engaging in another form of psychological therapy during the course of the study.
- •Having self-reported sufficient English language reading ability to read and understand the self-help book
排除标准
- •Being currently on leave of absence from work.
- •Having previously received a minimum dose (defined as 50% of a course or more) of a mindfulness-based intervention.
研究组 & 干预措施
MBCT-SH
MBCT-SH will be an unguided, mindfulness-based cognitive therapy, book-based self-help intervention.
干预措施: The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus. (Behavioral)
Control
A wait list control group who will receive no intervention during the 21 weeks of the study. Control participants will be provided with the self-help book that the MBCT-SH group received after week 21.
结局指标
主要结局
Stress
时间窗: Post-intervention (i.e. 9-weeks after baseline)
Change from baseline at 9-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21
次要结局
- Compassion for others (follow-up)(Follow-up (i.e. 21 weeks after baseline))
- Sickness absence(Follow-up (i.e. 21 weeks after baseline))
- Depression (follow-up)(Follow-up (i.e. 21 weeks after baseline))
- Mindfulness(Post-intervention (i.e. 9-weeks after baseline))
- Stress (follow-up)(Follow-up (i.e. 21 weeks after baseline))
- Depression(Post-intervention (i.e. 9-weeks after baseline))
- Anxiety(Post-intervention (i.e. 9-weeks after baseline))
- Self-compassion (follow-up)(Follow-up (i.e. 21 weeks after baseline))
- Burnout(Post-intervention (i.e. 9-weeks after baseline))
- Mental Wellbeing(Post-intervention (i.e. 9-weeks after baseline))
- Compassion for others(Post-intervention (i.e. 9-weeks after baseline))
- Mindfulness (follow-up)(Follow-up (i.e. 21 weeks after baseline))
- Burnout (follow-up)(Follow-up (i.e. 21 weeks after baseline))
- Mental Wellbeing (follow-up)(Follow-up (i.e. 21 weeks after baseline))
- Anxiety (follow-up)(Follow-up (i.e. 21 weeks after baseline))
- Self-compassion(Post-intervention (i.e. 9-weeks after baseline))