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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04690452
Other study ID # BRLUCM2020-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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©.

Study Design


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 allClick 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
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