Anxiety, Burn Out, Compassion, Depression, Empathy, MIndfulness, Resilience, Self-Compassion, Stress, Well-being
Conditions
Keywords
Compassion, Medical Student, Health, Training program, CCT
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. Program description: The Compassion Cultivation Training (CCT©) is an 8-week evidence-based standardized meditation program designed at Standford University. The CCT© is aimed at cultivating compassion and empathy toward oneself and others. The program is conducted in groups of 15-20 participants and consisting of weekly 2 hour on-line sessions (due to COVID-19 restrictions) with 20-30 minutes of daily formal meditation practices and informal compassion practices. The CCT© program will be guided by a certified instructor from the Compassion Institute. Program adherence and fidelity will be monitored through revisions of the recorded sessions. The CCT© program comprises six sequential steps: 1) Settling the mind; 2) Loving-kindness and compassion for a loved one; 3) Self-directed loving-kindness and compassion; 4) Common humanity; 5) Cultivating compassion for others; and 6) Active compassion (Tonglen).
Interventions
BEHAVIORALCompassion Cultivation Training
The Compassion Cultivation Training (CCT©) is an 8-week standardized meditation program conducted in groups of 15-20 participants and consisting of weekly 2 hour on-line sessions with 20-30 minutes of daily formal meditation practices and informal compassion practices. The CCT© program will be guided by a certified instructor form the Center for Compassion and Altruism Research and Education at Stanford University. The CCT© program comprises six sequential steps: 1) Settling the mind; 2) Loving-kindness and compassion for a loved one; 3) Self-directed loving-kindness and compassion; 4) Common humanity; 5) Cultivating compassion for others; and 6) Active compassion (Tonglen).
Sponsors
Nirakara Institute
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Single
Intervention model description
Medical students during academic year 2020-21 will be asked to participate in the present study. Once inclusion criteria are met, each participant will be randomly assigned to the experimental group or waitlist control. Randomization will be performed by using a computer-generated sequence
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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©.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months | up to 6 months. | Compassion Scale Pommier (CSP; Pommier et al., 2020). |
| Change in Compassion- Self-compassion at pre, post-intervention and at 2 and 6 months | up to 6 months. | Self- Compassion Scale (SCS-SF; Raes et al., 2011). |
| Change in Empathy at pre, post-intervention and at 2 and 6 months | 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 | up to 6 months. | Depression Anxiety Stress Scales (DASS- 21; Lovibond, & Lovibond, 1995). |
| Change in General well-being at pre, post-intervention and at 2 and 6 months | up to 6 months. | Pemberton Happiness Index (PHI, Hervas, & Vazquez, 2013). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mindfulness at pre, post-intervention and at 2 and 6 months | up to 6 months. | Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006). |
| Changes in State measures during intervention | up to 8 weeks | Single-item to measure state changes in: compassion, mindfulness, psychological distress, well-being, and cognitive-emotional regulation processes |
| Change in Burnout at pre, post-intervention and at 2 and 6 months | up to 6 months. | Maslach Burnout Inventory (Maslach & Jackson, 1981) |
| Change in Resilience at pre, post-intervention and at 2 and 6 months | up to 6 months. | Brief Resilience Scale (BRS; Smith et al., 2008). |
| Change in Emotion regulation at pre, post-intervention and at 2 and 6 months | up to 6 months. | Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004). |
| Change in Adherence to the program | up to 8 weeks | Single-item to measure daily formal meditation practices and informal compassion practices. |
Countries
Spain
Outcome results
None listed