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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690452
• Other study ID #: BRLUCM2020-1
• Status: Completed
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: September 24, 2021

Study information

• Verified date: November 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 24, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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©.

Related Conditions & MeSH terms

• Anxiety
• Burn Out
• Burnout, Psychological
• Compassion
• Depression
• Empathy
• MIndfulness
• Resilience
• Self-Compassion
• Stress
• Well-being

Intervention

Behavioral:
• Compassion 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).

Locations

Country	Name	City	State
Spain	Universidad Complutense Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Nirakara Institute

Country where clinical trial is conducted

Spain, 

References & Publications (14)

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. — View 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. — View Citation

Cruz A, Bühling M, Seibel K. [Double blind study of migraine therapy with etilefrine pivalate]. Arzneimittelforschung. 1985;35(7):1086-9. German. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Stepien KA, Baernstein A. Educating for empathy. A review. J Gen Intern Med. 2006 May;21(5):524-30. Review. — View Citation

van Donselaar CA, Habbema JD. Recurrence after first seizure. Lancet. 1991 Jan 5;337(8732):46. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Change in Empathy at pre, post-intervention and at 2 and 6 months	Interpersonal Reactivity Index (IRI, Davis, 1980).	up to 6 months.
Primary	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.
Primary	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	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.
Secondary	Change in Burnout at pre, post-intervention and at 2 and 6 months	Maslach Burnout Inventory (Maslach & Jackson, 1981)	up to 6 months.
Secondary	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.
Secondary	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.
Secondary	Change in Adherence to the program	Single-item to measure daily formal meditation practices and informal compassion practices.	up to 8 weeks
Secondary	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

External Links

•   Center for Mindful Self-Compassion
•   Compassion Institute
•   The Center for Compassion and Altruism Research and Education
•   The Compassionate Mind Foundation