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

Primary Purpose

Stress, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Compassion Cultivation Training
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress focused on measuring Compassion, Medical Student, Health, Training program, CCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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©.

Sites / Locations

  • Universidad Complutense Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention condition

Waitlist control condition

Arm Description

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/)

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.

Outcomes

Primary Outcome Measures

Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
Compassion Scale Pommier (CSP; Pommier et al., 2020).
Change in Compassion- Self-compassion at pre, post-intervention and at 2 and 6 months
Self- Compassion Scale (SCS-SF; Raes et al., 2011).
Change in Empathy at pre, post-intervention and at 2 and 6 months
Interpersonal Reactivity Index (IRI, Davis, 1980).
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).
Change in General well-being at pre, post-intervention and at 2 and 6 months
Pemberton Happiness Index (PHI, Hervas, & Vazquez, 2013).

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2020
Last Updated
November 3, 2022
Sponsor
Universidad Complutense de Madrid
Collaborators
Nirakara Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04690452
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
September 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Nirakara Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Depression, Anxiety, Burn Out, Well-being, Resilience, MIndfulness, Compassion, Self-Compassion, Empathy
Keywords
Compassion, Medical Student, Health, Training program, CCT

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Single
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention condition
Arm Type
Experimental
Arm Description
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/)
Arm Title
Waitlist control condition
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Compassion Cultivation Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
Description
Compassion Scale Pommier (CSP; Pommier et al., 2020).
Time Frame
up to 6 months.
Title
Change in Compassion- Self-compassion at pre, post-intervention and at 2 and 6 months
Description
Self- Compassion Scale (SCS-SF; Raes et al., 2011).
Time Frame
up to 6 months.
Title
Change in Empathy at pre, post-intervention and at 2 and 6 months
Description
Interpersonal Reactivity Index (IRI, Davis, 1980).
Time Frame
up to 6 months.
Title
Change in Psychological distress- feelings of stress, anxiety and depression at pre, post-intervention and at 2 and 6 months
Description
Depression Anxiety Stress Scales (DASS- 21; Lovibond, & Lovibond, 1995).
Time Frame
up to 6 months.
Title
Change in General well-being at pre, post-intervention and at 2 and 6 months
Description
Pemberton Happiness Index (PHI, Hervas, & Vazquez, 2013).
Time Frame
up to 6 months.
Secondary Outcome Measure Information:
Title
Change in Mindfulness at pre, post-intervention and at 2 and 6 months
Description
Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006).
Time Frame
up to 6 months.
Title
Change in Burnout at pre, post-intervention and at 2 and 6 months
Description
Maslach Burnout Inventory (Maslach & Jackson, 1981)
Time Frame
up to 6 months.
Title
Change in Resilience at pre, post-intervention and at 2 and 6 months
Description
Brief Resilience Scale (BRS; Smith et al., 2008).
Time Frame
up to 6 months.
Title
Change in Emotion regulation at pre, post-intervention and at 2 and 6 months
Description
Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004).
Time Frame
up to 6 months.
Title
Change in Adherence to the program
Description
Single-item to measure daily formal meditation practices and informal compassion practices.
Time Frame
up to 8 weeks
Title
Changes in State measures during intervention
Description
Single-item to measure state changes in: compassion, mindfulness, psychological distress, well-being, and cognitive-emotional regulation processes
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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©.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blanca Rojas, M.D., PhD
Organizational Affiliation
Universidad Complutense Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Complutense Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15327674
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.
Results Reference
background
PubMed Identifier
15671323
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.
Results Reference
background
PubMed Identifier
16704404
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.
Results Reference
background
PubMed Identifier
1670661
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.
Results Reference
background
PubMed Identifier
31077192
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.
Results Reference
background
PubMed Identifier
15312283
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.
Results Reference
background
PubMed Identifier
19582635
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.
Results Reference
background
PubMed Identifier
21248604
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.
Results Reference
background
PubMed Identifier
23024571
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.
Results Reference
background
PubMed Identifier
22836852
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.
Results Reference
background
PubMed Identifier
25258518
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.
Results Reference
background
PubMed Identifier
30911803
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.
Results Reference
background
PubMed Identifier
19385420
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.
Results Reference
background
PubMed Identifier
2864937
Citation
Cruz A, Buhling M, Seibel K. [Double blind study of migraine therapy with etilefrine pivalate]. Arzneimittelforschung. 1985;35(7):1086-9. German.
Results Reference
background
Links:
URL
http://ccare.stanford.edu/
Description
The Center for Compassion and Altruism Research and Education
URL
http://www.compassioninstitute.com/
Description
Compassion Institute
URL
http://self-compassion.org/
Description
Center for Mindful Self-Compassion
URL
http://www.compassionatemind.co.uk
Description
The Compassionate Mind Foundation

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

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