Evaluation of the Efficacy and Mechanisms of Change of Compassion Cultivation Training in Medical Students

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. 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).

Official Title
-----------------
Evaluation of the Efficacy and Mechanisms of Change of Compassion Cultivation Training in Medical Students

Conditions
-----------------
Stress, Depression, Anxiety, Burn Out, Well-being, Resilience, MIndfulness, Compassion, Self-Compassion, Empathy

Intervention / Treatment
-----------------
* Behavioral: Compassion Cultivation Training


Participation Criteria
=================
Eligibility Criteria
-----------------
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©.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention condition<br>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/) | Behavioral: Compassion Cultivation Training<br>* 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).<br>|
| Other: Waitlist control condition<br>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. | Behavioral: Compassion Cultivation Training<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months | Compassion Scale Pommier (CSP; Pommier et al., 2020). | up to 6 months. | 
| Change in Compassion- Self-compassion at pre, post-intervention and at 2 and 6 months | Self- Compassion Scale (SCS-SF; Raes et al., 2011). | up to 6 months. | 
| Change in Empathy at pre, post-intervention and at 2 and 6 months | Interpersonal Reactivity Index (IRI, Davis, 1980). | up to 6 months. | 
| Change in Psychological distress- feelings of stress, anxiety and depression at pre, post-intervention and at 2 and 6 months | Depression Anxiety Stress Scales (DASS- 21; Lovibond, & Lovibond, 1995). | up to 6 months. | 
| Change in General well-being at pre, post-intervention and at 2 and 6 months | Pemberton Happiness Index (PHI, Hervas, & Vazquez, 2013). | up to 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mindfulness at pre, post-intervention and at 2 and 6 months | Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006). | up to 6 months. | 
| Change in Burnout at pre, post-intervention and at 2 and 6 months | Maslach Burnout Inventory (Maslach & Jackson, 1981) | up to 6 months. | 
| Change in Resilience at pre, post-intervention and at 2 and 6 months | Brief Resilience Scale (BRS; Smith et al., 2008). | up to 6 months. | 
| Change in Emotion regulation at pre, post-intervention and at 2 and 6 months | Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004). | up to 6 months. | 
| Change in Adherence to the program | Single-item to measure daily formal meditation practices and informal compassion practices. | up to 8 weeks | 
| Changes in State measures during intervention | Single-item to measure state changes in: compassion, mindfulness, psychological distress, well-being, and cognitive-emotional regulation processes | up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Compassion, Medical Student, Health, Training program, CCT