Evaluation of the Efficacy and Mechanisms of Change of Compassion Cultivation Training in Medical Students
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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©.
Arms & Interventions
Intervention condition
Intervention group that receive a standardized 8 weeks Compassion Cultivation Training from a faculty member certified CCT© instructor (https://www.compassioninstitute.com/about-us/teacher-directory/)
Intervention: Compassion Cultivation Training (Behavioral)
Waitlist control condition
The participants assigned to the waitlist control will fill in the same questionnaires as the intervention group at the different time points (i.e., pre, post, 2-month and 6-month follow-ups).
Two months after finishing the intervention, will become participants of a CCT© program themselves given by the same faculty member certified CCT© teacher as for the experimental group.
Intervention: Compassion Cultivation Training (Behavioral)
Outcomes
Primary Outcomes
Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
Time Frame: 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
Time Frame: up to 6 months.
Pemberton Happiness Index (PHI, Hervas, \& Vazquez, 2013).
Change in Empathy at pre, post-intervention and at 2 and 6 months
Time Frame: 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
Time Frame: 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
Time Frame: up to 6 months.
Self- Compassion Scale (SCS-SF; Raes et al., 2011).
Secondary Outcomes
- 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)
Investigators
Blanca Rojas
Assistant Professor Faculty of Medicine
Universidad Complutense de Madrid