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

NCT04690452 | Completed

• 1 other identifier: BRLUCM2020-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Compassion; Medical Student; Health; Training program; CCT

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Change in Mindfulness at pre, post-intervention and at 2 and 6 months

  up to 6 months.

• Change in Burnout at pre, post-intervention and at 2 and 6 months

  up to 6 months.

• Change in Resilience at pre, post-intervention and at 2 and 6 months

  up to 6 months.

• Change in Emotion regulation at pre, post-intervention and at 2 and 6 months

  up to 6 months.

• Change in Adherence to the program

  up to 8 weeks

Study Arms (2)

Intervention condition

EXPERIMENTAL

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

Waitlist control condition

OTHER

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

Interventions

Compassion Cultivation Training BEHAVIORAL

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).

Intervention condition; Waitlist control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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©.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Nirakara Institute: collaborator

Study Sites (1)

Universidad Complutense Madrid

Madrid, 28040, Spain

Location

Related Publications (14)

• 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.

  PMID: 15327674 BACKGROUND

• 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.

  PMID: 15671323 BACKGROUND

• 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.

  PMID: 16704404 BACKGROUND

• 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.

  PMID: 1670661 BACKGROUND

• 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.

  PMID: 31077192 BACKGROUND

• 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.

  PMID: 15312283 BACKGROUND

• 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.

  PMID: 19582635 BACKGROUND

• 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.

  PMID: 21248604 BACKGROUND

• 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.

  PMID: 23024571 BACKGROUND

• 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.

  PMID: 22836852 BACKGROUND

• 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.

  PMID: 25258518 BACKGROUND

• 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.

  PMID: 30911803 BACKGROUND

• Hojat M. Ten approaches for enhancing empathy in health and human services cultures. J Health Hum Serv Adm. 2009 Spring;31(4):412-50.

  PMID: 19385420 BACKGROUND

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

  PMID: 2864937 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Depression; Anxiety Disorders; Burnout, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress, Psychological

Study Officials

• Blanca Rojas, M.D., PhD

  Universidad Complutense Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Faculty of Medicine

Model Details: 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

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 30, 2020
• Study Start: December 11, 2020
• Primary Completion: March 8, 2021
• Study Completion: September 24, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)