Resident BurnoutNCT02621801
Evaluation of a Mind-body Education Program to Enhance Resiliency and Reduce Burnout in Residents
A study testing Stress Management and Resiliency Training for Residents (SMART-R) in people with Resident Burnout, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This prospective, waitlist-control study is evaluating the benefits of a stress management and resiliency training program for residents (SMART-R). The primary aim of this study is to determine whether the SMART-R is effective at increasing coping skills and reducing stress among residents, reflected by changes in… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Resident Burnout
- What is being tested?
- Stress Management and Resiliency Training for Residents (SMART-R)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents in the following participating departments: departments of psychiatry, pediatrics, or neurology at MGH, medicine or psychiatry at NYU, or medicine or psychiatry at Cornell
Who cannot join
- Not a resident in the participating departments
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Benson-Henry Institute for Mind Body Medicine
Boston, Massachusetts, 02114
About this study
This prospective, waitlist-control study is evaluating the benefits of a stress management and resiliency training program for residents (SMART-R).
The primary aim of this study is to determine whether the SMART-R is effective at increasing coping skills and reducing stress among residents, reflected by changes in constructs such as emotional growth, perceived stress, optimism, and coping styles. Objective parameters (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy) measured with the Basis health tracking device will help correlate objective signs to subjective report of stress.
Read the detailed description
The investigators adapted the Benson-Henry Institute Stress Management and Resiliency Training Program -- Relaxation Response Resiliency Program (SMART-3RP) to create the SMART-R resident wellness curriculum. The actual SMART-3RP is both a clinical program and research intervention. The three prongs of the SMART-R include 1) elicitation of the relaxation response through mind-body techniques 2) reducing overall stress reactivity and 3) increasing connectedness to self and others.
In a waitlist-control design, the SMART-R was implemented into multiple residents programs at Mass General Hospital, NYU Langone Medical Center, and Weill Cornell Medical College. The primary aim is to evaluate the effectiveness of the SMART-R in increasing coping skills and reducing stress among residents in the participating programs. Participants enrolled will be invited to complete 1) a brief questionnaire before, during (q3months) and after participation in the program (5 questionnaires total). The investigators will also collect continuous physiologic data using the Basis Peak Health Tracking device to correlate the physiologic data with self-report measures of stress.
Additionally, objective indicators of daily workload (page frequency, and quantity of notes authored by a resident during a given period) will help control for residents' schedules and busyness, in evaluating perceived stress, wellbeing and other outcomes.
- Conditions
- Resident Burnout
- Being tested
- Stress Management and Resiliency Training for Residents (SMART-R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management and Resiliency Training for Residents (SMART-R)Behavioural
The Stress Management and Resiliency Training Program for residents (SMART-R) is a six-hour intervention delivered over 2 or 3 sessions that teaches residents mind-body skills to reduce stress and enhance coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Stress Management and Resiliency Training for Residents (SMART-R) Receives: Behavioral: Stress Management and Resiliency Training for Residents (SMART-R) |
| Waitlist Control | Active comparator | The control group will receive the same intervention (SMART-R) after the experimental group. Receives: Behavioral: Stress Management and Resiliency Training for Residents (SMART-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in burnout levels post intervention
Maslach Burnout Inventory (MBI), a validated 22-item self-report measure of professional burnout in human services. The MBI consists of 3 subscales of burnout: emotional exhaustion, depersonalization, and low sense of personal accomplishment.
Measured: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Secondary outcomes (3)
Change in perceived stress post intervention
Perceived Stress Scale (PSS-10)
Measured: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Change in continuous physiologic data throughout intervention
Basis Peak Health Tracking device collects continuous physiologic data (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy)
Measured: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
change in mindfulness post intervention
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Measured: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resident BurnoutStudies 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John W. Denninger, MD, PhD, Massachusetts General Hospital
- Investigators
- John W Denninger, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621801
- Sponsor's protocol ID
- 2015P000916
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2015
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chaukos D, Zebrowski JP, Benson NM, Celik A, Chad-Friedman E, Teitelbaum A, Bernstein C, Cook R, Genfi A, Denninger JW. "One size does not fit all" - lessons learned from a multiple-methods study of a resident wellness curriculum across sites and specialties. BMC Med Educ. 2021 Nov 13;21(1):576. doi: 10.1186/s12909-021-02995-z.
PubMed 34774057
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mind-body Education Program to Enhance Resiliency and Reduce Burnout in Residents
- ClinicalTrials.gov ID
- NCT02621801
- Acronym / sponsor ID
- 2015P000916
- Conditions
- Resident Burnout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- NYU Langone Health, Weill Medical College of Cornell University
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 4 Dec 2015 (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.
This prospective, waitlist-control study is evaluating the benefits of a stress management and resiliency training program for residents (SMART-R).
The primary aim of this study is to determine whether the SMART-R is effective at increasing coping skills and reducing stress among residents, reflected by changes in constructs such as emotional growth, perceived stress, optimism, and coping styles. Objective parameters (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy) measured with the Basis health tracking device will help correlate objective signs to subjective report of stress.
Detailed description
The investigators adapted the Benson-Henry Institute Stress Management and Resiliency Training Program -- Relaxation Response Resiliency Program (SMART-3RP) to create the SMART-R resident wellness curriculum. The actual SMART-3RP is both a clinical program and research intervention. The three prongs of the SMART-R include 1) elicitation of the relaxation response through mind-body techniques 2) reducing overall stress reactivity and 3) increasing connectedness to self and others.
In a waitlist-control design, the SMART-R was implemented into multiple residents programs at Mass General Hospital, NYU Langone Medical Center, and Weill Cornell Medical College. The primary aim is to evaluate the effectiveness of the SMART-R in increasing coping skills and reducing stress among residents in the participating programs. Participants enrolled will be invited to complete 1) a brief questionnaire before, during (q3months) and after participation in the program (5 questionnaires total). The investigators will also collect continuous physiologic data using the Basis Peak Health Tracking device to correlate the physiologic data with self-report measures of stress.
Additionally, objective indicators of daily workload (page frequency, and quantity of notes authored by a resident during a given period) will help control for residents' schedules and busyness, in evaluating perceived stress, wellbeing and other outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Stress Management and Resiliency Training for Residents (SMART-R)Stress Management and Resiliency Training for Residents (SMART-R) |
| Waitlist Control | Active comparator | Behavioral: Stress Management and Resiliency Training for Residents (SMART-R)The control group will receive the same intervention (SMART-R) after the experimental group. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Residents in the following participating departments: departments of psychiatry, pediatrics, or neurology at MGH, medicine or psychiatry at NYU, or medicine or psychiatry at Cornell
Key exclusion criteria (1 listed)
- Not a resident in the participating departments
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 |
|---|---|---|
| Stress Management and Resiliency Training for Residents (SMART-R)The Stress Management and Resiliency Training Program for residents (SMART-R) is a six-hour intervention delivered over 2 or 3 sessions that teaches residents mind-body skills to reduce stress and enhance coping strategies. | Behavioural | Intervention, Waitlist Control |
Primary outcome
Change in burnout levels post intervention
Time frame: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Maslach Burnout Inventory (MBI), a validated 22-item self-report measure of professional burnout in human services. The MBI consists of 3 subscales of burnout: emotional exhaustion, depersonalization, and low sense of personal accomplishment.
3 secondary outcomes
Change in perceived stress post intervention
Time frame: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Change in continuous physiologic data throughout intervention
Time frame: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
change in mindfulness post intervention
Time frame: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Derived from this study: PubMed 34774057Chaukos D, Zebrowski JP, Benson NM, Celik A, Chad-Friedman E, Teitelbaum A, Bernstein C, Cook R, Genfi A, Denninger JW. "One size does not fit all" - lessons learned from a multiple-methods study of a resident wellness curriculum across sites and specialties. BMC Med Educ. 2021 Nov 13;21(1):576. doi: 10.1186/s12909-021-02995-z.
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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.
John W Denninger, MD, PhD 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 Stress Management and Resiliency Training for Residents (SMART-R) in people with Resident Burnout, 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: status not confirmed, as of the sponsor's last update on 4 Dec 2015. 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?
Results are not available in the source record.
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 burnout levels post intervention (time frame: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)). 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 NCT02621801, which also lists 1 linked publication.
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 Dec 2015.