EmpathyNCT01304030
Improving Empathy and Relational Skills
A study testing Empathy Training Modules and Residency Training as usual in people with Empathy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Our research hypothesis is that residents who participate in the empathy and relational skills training modules will significantly improve in these skills as compared to a control group of residents who receive residency training as usual that includes the current standard training in the doctor-patient relationship. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Empathy
- What is being tested?
- Empathy Training Modules and Residency Training as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2010
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All medical and surgical residents who are based at Massachusetts General Hospital will be eligible to participate in the study.
Who cannot join
- Residents who are rotating at sites other then Massachusetts General Hospital Residents who are on rotations that do not include clinical care
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 021114
About this study
Official title: Improving Empathy and Relational Skills in Resident Physicians: A Randomized Controlled Trial
Our research hypothesis is that residents who participate in the empathy and relational skills training modules will significantly improve in these skills as compared to a control group of residents who receive residency training as usual that includes the current standard training in the doctor-patient relationship. To evaluate this hypothesis, we will use a two-pronged approach to assessment. The first prong is the residents' self assessment of empathy and the second is from the patients' perspective.
Read the detailed description
The study design is a randomized controlled trial assigning resident physicians (N=100) to either: (a) empathy and relational skills training; or (b) control group receiving standard residency training as usual. Over the course of six weeks, each resident physician in the experimental group will receive three 60-minute training sessions focused on empathy and relational skills (the residents assigned to the control condition will receive standard residency training as usual). The emerging neuroscience of emotions and empathy has provided the neurobiological and physiological bases for our Empathy Training Modules to enhance patient-doctor communication. These innovative modules provide the basic science and video modeling for empathy training. Based on cutting edge mirror neuron research, our training modules offer a novel approach to empathy and relational skills training that teaches physicians about the neurobiology and physiology of emotions in difficult or stressful patient interactions. We have developed professionally produced high definition training modules that portray difficult patient-physician interactions. Importantly, these videos also include physiological displays of emotion for both members of the dyad so that one can easily observe the degree to which patient and physician are physiologically concordant or discordant with one another. The empathy training is conducted at a deeper level of physiological awareness and regulation that promises to be more effective than traditional didactic teaching by integrating the technology of psychophysiology. The goal of raising awareness of physiologic indices during a patient-doctor interaction is to present an objective measure of emotional response to both explicit and implicit stimuli, which promises to be a powerful teaching tool to enhance empathic physician behaviors.
- Conditions
- Empathy
- Being tested
- Empathy Training Modules, Residency Training as usual
- Keywords
- Empathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empathy Training ModulesBehavioural
Also called E.M.P.A.T.H.Y. (TM)
The Empathy Training Modules utilize translational research in emotion expression basic science, physiology of emotions, decoding facial expressions and self-regulation skills as pertaining to management of medical and surgical patients.
Residency Training as usualBehavioural
Also called Residency Training
Residents will receive their typical didactic and clinical education
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group receives Empathy Training. The control Group receives residency training as usual Receives: Behavioral: Empathy Training Modules |
| Control Group | Active comparator | The control group receives residency training as usual Receives: Behavioral: Residency Training as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consultation and Relational Empathy Measure (CARE) measure
At baseline: (1) Residents will complete the CARE measure (2) 10 patients in each resident's clinic will rate their encounter using the CARE Measure; (3) Residents will receive the Empathy and Relational Training Modules or residency training as usual. At the six-week endpoint: (4) residents will complete the CARE measure and (5) patients will complete the CARE measure after the clinic visit.
Measured: Up to 5 weeks (this is an average)
Secondary outcomes (1)
Jefferson Empathy Scale Mehrabian Balanced Emotional Empathy Scale (BEES) (30 items) 2.Jefferson Empathy Scale (20 items 3. Neuroscience of Emotions Assessment 4. Ekman Facial Expression Decoding Assessment
The Mehrabian BEES Measures baseline empathy. The Jefferson Scale measures physician attitudes about the importance of empathy in clinical medical care. The Neuroscience of Emotions Test measures knowledge of basic science of emotions. The Ekman test measures ability to decode subtle facial expressions.
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EmpathyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Helen Riess, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304030
- Sponsor's protocol ID
- 2009P001599
- Other IDs
- P001599
- Status last verified
- Feb 2011
- First submitted
- 19 Feb 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Riess H. Empathy in medicine--a neurobiological perspective. JAMA. 2010 Oct 13;304(14):1604-5. doi: 10.1001/jama.2010.1455. No abstract available.
PubMed 20940387Riess H, Kelley JM, Bailey R, Konowitz PM, Gray ST. Improving empathy and relational skills in otolaryngology residents: a pilot study. Otolaryngol Head Neck Surg. 2011 Jan;144(1):120-2. doi: 10.1177/0194599810390897.
PubMed 21493400
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Empathy and Relational Skills in Resident Physicians: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01304030
- Acronym / sponsor ID
- 2009P001599
- Conditions
- Empathy
- Keywords
- Empathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Feb 2011 (estimated)
- 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.
Our research hypothesis is that residents who participate in the empathy and relational skills training modules will significantly improve in these skills as compared to a control group of residents who receive residency training as usual that includes the current standard training in the doctor-patient relationship. To evaluate this hypothesis, we will use a two-pronged approach to assessment. The first prong is the residents' self assessment of empathy and the second is from the patients' perspective.
Detailed description
The study design is a randomized controlled trial assigning resident physicians (N=100) to either: (a) empathy and relational skills training; or (b) control group receiving standard residency training as usual. Over the course of six weeks, each resident physician in the experimental group will receive three 60-minute training sessions focused on empathy and relational skills (the residents assigned to the control condition will receive standard residency training as usual). The emerging neuroscience of emotions and empathy has provided the neurobiological and physiological bases for our Empathy Training Modules to enhance patient-doctor communication. These innovative modules provide the basic science and video modeling for empathy training. Based on cutting edge mirror neuron research, our training modules offer a novel approach to empathy and relational skills training that teaches physicians about the neurobiology and physiology of emotions in difficult or stressful patient interactions. We have developed professionally produced high definition training modules that portray difficult patient-physician interactions. Importantly, these videos also include physiological displays of emotion for both members of the dyad so that one can easily observe the degree to which patient and physician are physiologically concordant or discordant with one another. The empathy training is conducted at a deeper level of physiological awareness and regulation that promises to be more effective than traditional didactic teaching by integrating the technology of psychophysiology. The goal of raising awareness of physiologic indices during a patient-doctor interaction is to present an objective measure of emotional response to both explicit and implicit stimuli, which promises to be a powerful teaching tool to enhance empathic physician behaviors.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Empathy Training ModulesThe experimental group receives Empathy Training. The control Group receives residency training as usual |
| Control Group | Active comparator | Behavioral: Residency Training as usualThe control group receives residency training as usual |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All medical and surgical residents who are based at Massachusetts General Hospital will be eligible to participate in the study.
Key exclusion criteria (1 listed)
- Residents who are rotating at sites other then Massachusetts General Hospital Residents who are on rotations that do not include clinical care
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 |
|---|---|---|
| Empathy Training ModulesAlso: E.M.P.A.T.H.Y. (TM)The Empathy Training Modules utilize translational research in emotion expression basic science, physiology of emotions, decoding facial expressions and self-regulation skills as pertaining to management of medical and surgical patients. | Behavioural | Experimental Group |
| Residency Training as usualAlso: Residency TrainingResidents will receive their typical didactic and clinical education | Behavioural | Control Group |
Primary outcome
Consultation and Relational Empathy Measure (CARE) measure
Time frame: Up to 5 weeks (this is an average)
At baseline: (1) Residents will complete the CARE measure (2) 10 patients in each resident's clinic will rate their encounter using the CARE Measure; (3) Residents will receive the Empathy and Relational Training Modules or residency training as usual. At the six-week endpoint: (4) residents will complete the CARE measure and (5) patients will complete the CARE measure after the clinic visit.
1 secondary outcome
Jefferson Empathy Scale Mehrabian Balanced Emotional Empathy Scale (BEES) (30 items) 2.Jefferson Empathy Scale (20 items 3. Neuroscience of Emotions Assessment 4. Ekman Facial Expression Decoding Assessment
Time frame: Prospective
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 25 Feb 2011.
- Background: PubMed 20940387Riess H. Empathy in medicine--a neurobiological perspective. JAMA. 2010 Oct 13;304(14):1604-5. doi: 10.1001/jama.2010.1455. No abstract available.
- Background: PubMed 21493400Riess H, Kelley JM, Bailey R, Konowitz PM, Gray ST. Improving empathy and relational skills in otolaryngology residents: a pilot study. Otolaryngol Head Neck Surg. 2011 Jan;144(1):120-2. doi: 10.1177/0194599810390897.
Related trials for Empathy
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Empathy, Anxiety
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Schizophrenia Disorder
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Development of the '1 Situation-5 Minutes' Game and Evaluation of Its Impact on Care Awareness and Empathy: A Mixed-Methods Study
Nursing Students' Care Awareness and Empathy
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The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study
Nurse's Role, Empathy
Active, not recruiting
Online Socio-emotional Dyad Training for Healthcare Students' Well-being and Social Skills
Intervention Condition, Control (Delayed Training) Condition
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.
Helen Riess, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empathy Training Modules and Residency Training as usual in people with Empathy, run by Massachusetts General Hospital at 1 site in United States.
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 1 inclusion and 1 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 25 Feb 2011. 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 United States. 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?
Consultation and Relational Empathy Measure (CARE) measure (time frame: Up to 5 weeks (this is an average)). 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 NCT01304030, which also lists 2 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 25 Feb 2011.