A Randomized Controlled Trial of an 8-Week Mindfulness "Booster" Course for Staff: Examining Effectiveness, Mediators of Impact, and Participant Experiences
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 11-12.
研究概览
简要总结
The goal of this clinical trial is to learn if a mindfulness booster course can reduce stress in healthcare staff who have previously attended a mindfulness course. The main questions it aims to answer are:
- Is a mindfulness booster course for healthcare staff effective at reducing their stress levels?
- Are any benefits maintained for 8 weeks?
Researchers will compare a mindfulness booster course with usual care to see if it helps to reduce stress. Participants will take part in either a mindfulness booster course or do what they usually do to look after their wellbeing. They will complete questionnaires at the beginning, middle and end of the study.
详细描述
Aims:
- To determine whether the mindfulness booster course for healthcare staff is effective in terms of the primary outcome (perceived stress) and secondary outcomes (wellbeing, depression, burnout, and compassion for others), and whether any benefits are maintained at follow-up.
- To examine whether any effects on the above-mentioned outcomes are statistically mediated by changes in amount of mindfulness practice, rumination and worry, decentering, self-compassion, and trait mindfulness.
- To develop an abbreviated grounded theory of the therapeutic process and outcomes of the mindfulness booster course.
Hypotheses:
- a) The primary hypothesis is that we will see a significantly greater decrease in the primary outcome of perceived stress at post-intervention (the primary time-point of Weeks 11-12) relative to baseline (Weeks 0-1) for the 'mindfulness-booster course plus treatment as usual (TAU)' intervention group compared to the 'TAU-only' control group.
b) Our secondary hypothesis is that we will see significantly greater improvements in each of our secondary outcome measures at post-intervention (Weeks 11-12) relative to baseline for our intervention group compared to our control group. Improvements entail decreases in depression and burnout and increases in compassion for others and wellbeing.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •UK National Health Service staff member.
- •Has completed an 8-week mindfulness course (either MBCT, MBCT-L or MBSR). Individuals will be considered to have "completed" a mindfulness course if they attended four or more sessions.
- •Is able to make one of the planned sets of times for the booster course sessions, in case they are randomly allocated to the intervention arm.
排除标准
- •Currently on sick leave.
- •Planning on undertaking another 8-week mindfulness course.
- •Previously participated in the mindfulness booster course in the feasibility study.
- •Have previously found practising mindfulness distressing.
研究组 & 干预措施
Treatment as usual control
干预措施: Usual Care (Behavioral)
Mindfulness Booster Course
干预措施: Mindfulness Booster Course (Behavioral)
Mindfulness Booster Course
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 11-12.
时间窗: Baseline (Weeks 0-1) and Weeks 11-12
The 10-item Perceived Stress Scale (PSS-10) is a self-report measure of perceived stress, which produces a score ranging between 0 and 40. A higher score indicates greater perceived stress.
次要结局
- Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 19-20.(Baseline (Weeks 0-1) and Weeks 19-20)
- Change in 8-item Patient Health Questionnaire score from baseline (Weeks 0-1) at Weeks 11-12.(Baseline (Weeks 0-1) and Weeks 11-12.)
- Change in 8-item Patient Health Questionnaire score from baseline (Weeks 0-1) at Weeks 19-20.(Baseline (Weeks 0-1) and Weeks 19-20)
- Change in Brief Sussex-Oxford Compassion for Others Scale score from baseline (Weeks 0-1) at Weeks 11-12.(Baseline (Weeks 0-1) and Weeks 11-12.)
- Change in Brief Sussex-Oxford Compassion for Others Scale score from baseline (Weeks 0-1) at Weeks 19-20.(Baseline (Weeks 0-1) and Weeks 19-20)
- Change in Sussex Burnout Scale score from baseline (Weeks 0-1) at Weeks 11-12.(Baseline (Weeks 0-1) and Weeks 11-12.)
- Change in Sussex Burnout Scale score from baseline (Weeks 0-1) at Weeks 19-20.(Baseline (Weeks 0-1) and Weeks 19-20.)
- Change in Short Warwick-Edinburgh Mental Wellbeing Scale score from baseline (Weeks 0-1) at Weeks 11-12.(Baseline (Weeks 0-1) and Weeks 11-12.)
- Change in Short Warwick-Edinburgh Mental Wellbeing Scale score from baseline (Weeks 0-1) at Weeks 19-20.(Baseline (Weeks 0-1) and Weeks 19-20.)