Universidad Complutense Madrid
Madrid, 28040, Spain
NCT Number: NCT04690452
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Madrid, 28040, Spain
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:
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: up to 6 months.
Compassion Scale Pommier (CSP; Pommier et al., 2020).
Time frame: up to 6 months.
Self- Compassion Scale (SCS-SF; Raes et al., 2011).
Time frame: up to 6 months.
Interpersonal Reactivity Index (IRI, Davis, 1980).
Time frame: up to 6 months.
Depression Anxiety Stress Scales (DASS- 21; Lovibond, & Lovibond, 1995).
Time frame: up to 6 months.
Pemberton Happiness Index (PHI, Hervas, & Vazquez, 2013).
Time frame: up to 6 months.
Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006).
Time frame: up to 6 months.
Maslach Burnout Inventory (Maslach & Jackson, 1981)
Time frame: up to 6 months.
Brief Resilience Scale (BRS; Smith et al., 2008).
Time frame: up to 6 months.
Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004).
Time frame: up to 8 weeks
Single-item to measure daily formal meditation practices and informal compassion practices.
Time frame: up to 8 weeks
Single-item to measure state changes in: compassion, mindfulness, psychological distress, well-being, and cognitive-emotional regulation processes
Universidad Complutense de Madrid
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06621108
Anxiety, Anxiety Disorders
Hong Kong
View Trial DetailsNCT05227794
Anxiety, Anxiety Disorders
New Haven, Connecticut, United States
View Trial DetailsNCT05051969
Anxiety, Anxiety Disorders
Nashville, Tennessee, United States
View Trial DetailsNCT06595849
Anxiety, Anxiety Disorders
Hong Kong
View Trial Details