Evaluation of the Efficacy and Mechanisms of Change of Compassion Cultivation Training in Medical Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
研究概览
简要总结
The aim of this randomized, waitlist controlled trial is to examine the efficacy of the Compassion Cultivation Training (CCT©) in reducing psychological distress (i.e., stress, anxiety and depression) and burnout symptoms while improving psychological well-being medical students. The second goal of the study is to examine whether mindfulness and compassion-related variables as well as emotional-cognitive emotional regulation processes mediate the psychological distress and well-being changes.
The effects of the CCT© program will be measured by means of self-report questionnaires involving different domains (mindfulness, compassion, distress, and well-being measures) at different time points (pre-intervention, inter-session assessment, post-intervention, 2-month and 6-month follow-up).
详细描述
Compassion and empathy are essential components of health care quality. Several studies have found a significant decrease in empathy and compassion levels during medical school and residency (Hojat, 2004; Bellini, 2005; Stephen, 2006; Neumann, 2011). However, compassion training is usually excluded from medical education. Compassion training in medical students can increase their wellness and decreased burnout (Weingartner, 2019), which in turn improves patients clinical outcomes (Kim, 2004; Rakel, 2009; Hojat, 2011; Attar 2012; Del Canale, 2012; Steinhausen, 2014; Trzeciak, 2017; Moss, 2019). Given that compassion can be trained through standardized interventions (Stephen, 2006; Hojat, 2009a; Goetz, 2010; Kelm, 2014) and educational programs (Patel, 2019), it highlight the need to investigate interventions aimed to improving both, provider self-care and patient care.
Hypothesis:
- Compassion Cultivation Training (CCT©) program would improve psychological well-being while reducing psychological distress (stress, anxiety and depression) and burnout symptoms in medical students as compared to a waitlist control group.
- These improvements would be maintained at 2 and 6 months after finishing the program.
- Mindfulness and compassion changes and emotional-cognitive emotional regulation processes would mediate the relationship between the program and the psychological distress and well-being changes.
- Compassion skills after the program will be a protective factor for stress and worry produced by COVID-19 pandemic.
Procedure:
The study will follow a randomised waitlist controlled trial with five assessment moments (i.e., pre, inter-session, post, 2-month and 6-month follow-ups). Participants will be recruited via constitutional email and the informative screens of the Medical School at Complutense University of Madrid. Participants will be randomized to either CCT© group (N=20) or waiting list control group (N=20). The procedure will include an online assessment via Qualtrics software at the different time points, as well as the completion of a "practice diary" as the inter-session assessment one per week the day before each session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single
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
- •18 years of age or more.
- •Medical students at University Complutense of Madrid.
- •Fluency in oral Spanish
- •Providing written, informed consent
- •Attendance commitment to all sessions of the program
- •Internet and computer access
排除标准
- •Severe mental disorder in active phase.
- •Being under alcohol and other drugs influence during weekly sessions and assessments
- •Participation in another meditation standardized program during CCT©.
结局指标
主要结局
Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
时间窗: up to 6 months.
Compassion Scale Pommier (CSP; Pommier et al., 2020).
Change in General well-being at pre, post-intervention and at 2 and 6 months
时间窗: up to 6 months.
Pemberton Happiness Index (PHI, Hervas, \& Vazquez, 2013).
Change in Empathy at pre, post-intervention and at 2 and 6 months
时间窗: up to 6 months.
Interpersonal Reactivity Index (IRI, Davis, 1980).
Change in Psychological distress- feelings of stress, anxiety and depression at pre, post-intervention and at 2 and 6 months
时间窗: up to 6 months.
Depression Anxiety Stress Scales (DASS- 21; Lovibond, \& Lovibond, 1995).
Change in Compassion- Self-compassion at pre, post-intervention and at 2 and 6 months
时间窗: up to 6 months.
Self- Compassion Scale (SCS-SF; Raes et al., 2011).
次要结局
- Change in Resilience at pre, post-intervention and at 2 and 6 months(up to 6 months.)
- Change in Adherence to the program(up to 8 weeks)
- Change in Mindfulness at pre, post-intervention and at 2 and 6 months(up to 6 months.)
- Change in Emotion regulation at pre, post-intervention and at 2 and 6 months(up to 6 months.)
- Change in Burnout at pre, post-intervention and at 2 and 6 months(up to 6 months.)
- Changes in State measures during intervention(up to 8 weeks)
研究者
Blanca Rojas
Assistant Professor Faculty of Medicine
Universidad Complutense de Madrid