Clinical trial NCT04690452: Evaluation of the Efficacy and Mechanisms of Change of Compassion Cultivation Training in Medical Students
Official title: Evaluation of the Efficacy and Mechanisms of Change of Compassion Cultivation Training in Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Depression
Anxiety
Burn Out
Well-being
Resilience
MIndfulness
Compassion
Self-Compassion
Empathy
Keywords: Compassion
Medical Student
Health
Training program
CCT
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Nirakara Institute
First posted: 2020-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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).

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©.

Primary outcomes:
measure: Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
measure: Change in Compassion- Self-compassion at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
measure: Change in Empathy at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
measure: Change in Psychological distress- feelings of stress, anxiety and depression at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
measure: Change in General well-being at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
Secondary outcomes:
measure: Change in Mindfulness at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
measure: Change in Burnout at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
measure: Change in Resilience at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
measure: Change in Emotion regulation at pre, post-intervention and at 2 and 6 months
timeFrame: up to 6 months.
measure: Change in Adherence to the program
timeFrame: up to 8 weeks
measure: Changes in State measures during intervention
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense Madrid
Study officials:
affiliation: Universidad Complutense Madrid
name: Blanca Rojas, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hojat M, Mangione S, Nasca TJ, Rattner S, Erdmann JB, Gonnella JS, Magee M. An empirical study of decline in empathy in medical school. Med Educ. 2004 Sep;38(9):934-41. doi: 10.1111/j.1365-2929.2004.01911.x.
citation: Bellini LM, Shea JA. Mood change and empathy decline persist during three years of internal medicine training. Acad Med. 2005 Feb;80(2):164-7. doi: 10.1097/00001888-200502000-00013.
citation: Stepien KA, Baernstein A. Educating for empathy. A review. J Gen Intern Med. 2006 May;21(5):524-30. doi: 10.1111/j.1525-1497.2006.00443.x.
citation: van Donselaar CA, Habbema JD. Recurrence after first seizure. Lancet. 1991 Jan 5;337(8732):46. doi: 10.1016/0140-6736(91)93361-c. No abstract available.
citation: Weingartner LA, Sawning S, Shaw MA, Klein JB. Compassion cultivation training promotes medical student wellness and enhanced clinical care. BMC Med Educ. 2019 May 10;19(1):139. doi: 10.1186/s12909-019-1546-6.
citation: Kim SS, Kaplowitz S, Johnston MV. The effects of physician empathy on patient satisfaction and compliance. Eval Health Prof. 2004 Sep;27(3):237-51. doi: 10.1177/0163278704267037.
citation: Rakel DP, Hoeft TJ, Barrett BP, Chewning BA, Craig BM, Niu M. Practitioner empathy and the duration of the common cold. Fam Med. 2009 Jul-Aug;41(7):494-501.
citation: Hojat M, Louis DZ, Markham FW, Wender R, Rabinowitz C, Gonnella JS. Physicians' empathy and clinical outcomes for diabetic patients. Acad Med. 2011 Mar;86(3):359-64. doi: 10.1097/ACM.0b013e3182086fe1.
citation: Attar HS, Chandramani S. Impact of physician empathy on migraine disability and migraineur compliance. Ann Indian Acad Neurol. 2012 Aug;15(Suppl 1):S89-94. doi: 10.4103/0972-2327.100025.
citation: Del Canale S, Louis DZ, Maio V, Wang X, Rossi G, Hojat M, Gonnella JS. The relationship between physician empathy and disease complications: an empirical study of primary care physicians and their diabetic patients in Parma, Italy. Acad Med. 2012 Sep;87(9):1243-9. doi: 10.1097/ACM.0b013e3182628fbf.
citation: Steinhausen S, Ommen O, Antoine SL, Koehler T, Pfaff H, Neugebauer E. Short- and long-term subjective medical treatment outcome of trauma surgery patients: the importance of physician empathy. Patient Prefer Adherence. 2014 Sep 18;8:1239-53. doi: 10.2147/PPA.S62925. eCollection 2014.
citation: Moss J, Roberts MB, Shea L, Jones CW, Kilgannon H, Edmondson DE, Trzeciak S, Roberts BW. Healthcare provider compassion is associated with lower PTSD symptoms among patients with life-threatening medical emergencies: a prospective cohort study. Intensive Care Med. 2019 Jun;45(6):815-822. doi: 10.1007/s00134-019-05601-5. Epub 2019 Mar 25.
citation: Hojat M. Ten approaches for enhancing empathy in health and human services cultures. J Health Hum Serv Adm. 2009 Spring;31(4):412-50.
citation: Cruz A, Buhling M, Seibel K. [Double blind study of migraine therapy with etilefrine pivalate]. Arzneimittelforschung. 1985;35(7):1086-9. German.