StressNCT04690452
Evaluation of the Efficacy and Mechanisms of Change of Compassion Cultivation Training in Medical Students
A study testing Compassion Cultivation Training in people with Stress and Depression, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression, Anxiety
- What is being tested?
- Compassion Cultivation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 11 Dec 2020to 24 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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©.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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).
- Conditions
- Stress, Depression, Anxiety, Burn Out, Well-being, Resilience
- Being tested
- Compassion Cultivation Training
- Keywords
- Compassion, Medical Student, Health, Training program, CCT
- Medical subject headings
- Depression, Anxiety Disorders, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Cultivation TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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/) Receives: 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. Receives: Behavioral: Compassion Cultivation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
Compassion Scale Pommier (CSP; Pommier et al., 2020).
Measured: 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).
Measured: up to 6 months.
Change in Empathy at pre, post-intervention and at 2 and 6 months
Interpersonal Reactivity Index (IRI, Davis, 1980).
Measured: 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).
Measured: 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).
Measured: up to 6 months.
Secondary outcomes (6)
Change in Mindfulness at pre, post-intervention and at 2 and 6 months
Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006).
Measured: up to 6 months.
Change in Burnout at pre, post-intervention and at 2 and 6 months
Maslach Burnout Inventory (Maslach \& Jackson, 1981)
Measured: up to 6 months.
Change in Resilience at pre, post-intervention and at 2 and 6 months
Brief Resilience Scale (BRS; Smith et al., 2008).
Measured: up to 6 months.
Change in Emotion regulation at pre, post-intervention and at 2 and 6 months
Difficulties in Emotion Regulation Scale (DERS, Gratz \& Roemer, 2004).
Measured: up to 6 months.
Change in Adherence to the program
Single-item to measure daily formal meditation practices and informal compassion practices.
Measured: up to 8 weeks
Changes in State measures during intervention
Single-item to measure state changes in: compassion, mindfulness, psychological distress, well-being, and cognitive-emotional regulation processes
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start11 Dec 2020
- Primary completion8 Mar 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Nirakara Institute
- Responsible party
- Principal investigator, Blanca Rojas, Universidad Complutense de Madrid
- Investigators
- Blanca Rojas, M.D., PhD, Principal investigator, Universidad Complutense Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690452
- Sponsor's protocol ID
- BRLUCM2020-1
- Status last verified
- Nov 2022
- First submitted
- 22 Dec 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15327674Bellini 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.
PubMed 15671323Stepien 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.
PubMed 16704404van 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.
PubMed 1670661Weingartner 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.
PubMed 31077192Kim 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.
PubMed 15312283Rakel 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.
PubMed 19582635Hojat 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.
PubMed 21248604Attar 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.
PubMed 23024571Del 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.
PubMed 22836852Steinhausen 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.
PubMed 25258518Moss 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.
PubMed 30911803Hojat M. Ten approaches for enhancing empathy in health and human services cultures. J Health Hum Serv Adm. 2009 Spring;31(4):412-50.
PubMed 19385420Cruz A, Buhling M, Seibel K. [Double blind study of migraine therapy with etilefrine pivalate]. Arzneimittelforschung. 1985;35(7):1086-9. German.
PubMed 2864937
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Mechanisms of Change of Compassion Cultivation Training in Medical Students
- ClinicalTrials.gov ID
- NCT04690452
- Acronym / sponsor ID
- BRLUCM2020-1
- Conditions
- Stress, Depression, Anxiety, Burn Out, Well-being, Resilience
- Keywords
- Compassion, Medical Student, Health, Training program, CCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Nirakara Institute
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Behavioral: Compassion Cultivation TrainingIntervention 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/) |
| Waitlist control condition | Other | Behavioral: Compassion Cultivation TrainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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©.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion Cultivation TrainingThe 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). | Behavioural | Intervention condition, Waitlist control condition |
Primary outcome
Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months
Time frame: up to 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
Time frame: up to 6 months.
Self- Compassion Scale (SCS-SF; Raes et al., 2011).
Change in Empathy at pre, post-intervention and at 2 and 6 months
Time frame: up to 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
Time frame: up to 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
Time frame: up to 6 months.
Pemberton Happiness Index (PHI, Hervas, \& Vazquez, 2013).
6 secondary outcomes
Change in Mindfulness at pre, post-intervention and at 2 and 6 months
Time frame: up to 6 months.
Change in Burnout at pre, post-intervention and at 2 and 6 months
Time frame: up to 6 months.
Change in Resilience at pre, post-intervention and at 2 and 6 months
Time frame: up to 6 months.
Change in Emotion regulation at pre, post-intervention and at 2 and 6 months
Time frame: up to 6 months.
Change in Adherence to the program
Time frame: up to 8 weeks
Changes in State measures during intervention
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 15327674Hojat 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.
- Background: PubMed 15671323Bellini 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.
- Background: PubMed 16704404Stepien 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.
- Background: PubMed 1670661van 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.
- Background: PubMed 31077192Weingartner 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.
- Background: PubMed 15312283Kim 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.
- Background: PubMed 19582635Rakel 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.
- Background: PubMed 21248604Hojat 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.
- Background: PubMed 23024571Attar 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.
- Background: PubMed 22836852Del 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.
- Background: PubMed 25258518Steinhausen 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.
- Background: PubMed 30911803Moss 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.
- The Center for Compassion and Altruism Research and EducationLink provided by the sponsor.
- Compassion InstituteLink provided by the sponsor.
- Center for Mindful Self-CompassionLink provided by the sponsor.
- The Compassionate Mind FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blanca Rojas, M.D., PhD principal investigator
Universidad Complutense Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion Cultivation Training in people with Stress and Depression, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Compassion- Compassion to others at pre, post-intervention and at 2 and 6 months (time frame: up to 6 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690452, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.