StressNCT02621788
Evaluation of Mind-body Educational Program to Enhance Resiliency and Reduce Burnout in First Year Residents
A study testing Stress Management and Resiliency Training for Residents (SMART-R) in people with Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This prospective pilot study evaluated the benefits of a stress management and resiliency training program for residents (SMART-R). The primary objective of this study is to determine whether the SMART-R effectively reduces burnout and stress and enhances coping skills in first year residents. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- 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
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Massachusetts General Hospital first year resident in Department of Medicine or Department of Psychiatry
- 21 years of age or older
- consenting to participate in 3RP-1
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH department of medicine and department of psychiatry
Boston, Massachusetts, 02114
About this study
This prospective pilot study evaluated the benefits of a stress management and resiliency training program for residents (SMART-R).
The primary objective of this study is to determine whether the SMART-R effectively reduces burnout and stress and enhances coping skills in first year residents. 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.
The investigators' hypothesis is that the SMART-R, a curriculum designed to teach first year residents (in the department of Medicine and Psychiatry) relaxation skills, will enhance residents' emotional and physical well being, reduce reports of stress, anxiety, depression, and physical complaints, as well as increase overall resiliency.
Read the detailed description
The SMART-R has been developed by the Benson-Henry Institute (BHI) of Mind Body Medicine and is aimed at reducing the impact of stress through a variety of skill building exercises. The exercises incorporated into the program have been shown to improve physical symptoms, mood and wellbeing in medical patient populations. However, very little work has focused on healthcare providers, and there are no studies that look at mindfulness interventions for resident physicians specifically.
Participants enrolled will be invited to complete a set of questionnaire before and after participation in the program. 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.
- Conditions
- Stress
- Being tested
- Stress Management and Resiliency Training for Residents (SMART-R)
- Keywords
- mind/body medicine, 3RP, stress management, resident burnout
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 SMART-R is a mind-body Educational Program for residents that is aimed at reducing the impact of stress and enhancing coping strategies through skill building exercises. The intervention consists of 3, 2 hour sessions over the course of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| First Year Residents | Experimental | Stress Management and Resiliency Training for Residents (SMART-R) delivered to first year residents in the departments of medicine and psychiatry at Massachusetts General Hospital 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 (week 0) and post intervention (week 52)
Change in perceived stress post intervention
Perceived Stress Scale (PSS-10)
Measured: change between baseline (week 0) and 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 (week 0) and post intervention (week 52)
change in coping abilities post intervention
Measure of Coping Status-Revised (MOCS-R)
Measured: change between baseline (week 0) and post intervention (week 52)
Secondary outcomes (1)
change in self-reported anxiety and depression
Beck Anxiety Inventory (BAI) and Patient Health Questionnaire 9-item
Measured: change between baseline (week 0) and 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 startApr 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 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 Denninger, M.D./PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621788
- Sponsor's protocol ID
- 2014P000234
- Status last verified
- Dec 2015
- First submitted
- 14 May 2015
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 Mind-body Educational Program to Enhance Resiliency and Reduce Burnout in First Year Residents
- ClinicalTrials.gov ID
- NCT02621788
- Acronym / sponsor ID
- 2014P000234
- Conditions
- Stress
- Keywords
- mind/body medicine, 3RP, stress management, resident burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- 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 pilot study evaluated the benefits of a stress management and resiliency training program for residents (SMART-R).
The primary objective of this study is to determine whether the SMART-R effectively reduces burnout and stress and enhances coping skills in first year residents. 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.
The investigators' hypothesis is that the SMART-R, a curriculum designed to teach first year residents (in the department of Medicine and Psychiatry) relaxation skills, will enhance residents' emotional and physical well being, reduce reports of stress, anxiety, depression, and physical complaints, as well as increase overall resiliency.
Detailed description
The SMART-R has been developed by the Benson-Henry Institute (BHI) of Mind Body Medicine and is aimed at reducing the impact of stress through a variety of skill building exercises. The exercises incorporated into the program have been shown to improve physical symptoms, mood and wellbeing in medical patient populations. However, very little work has focused on healthcare providers, and there are no studies that look at mindfulness interventions for resident physicians specifically.
Participants enrolled will be invited to complete a set of questionnaire before and after participation in the program. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First Year Residents | Experimental | Behavioral: Stress Management and Resiliency Training for Residents (SMART-R)Stress Management and Resiliency Training for Residents (SMART-R) delivered to first year residents in the departments of medicine and psychiatry at Massachusetts General Hospital |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Massachusetts General Hospital first year resident in Department of Medicine or Department of Psychiatry
- 21 years of age or older
- consenting to participate in 3RP-1
Key exclusion criteria (1 listed)
- -
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 SMART-R is a mind-body Educational Program for residents that is aimed at reducing the impact of stress and enhancing coping strategies through skill building exercises. The intervention consists of 3, 2 hour sessions over the course of 12 months. | Behavioural | First Year Residents |
Primary outcome
Change in burnout levels post intervention
Time frame: change between baseline (week 0) and 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.
Change in perceived stress post intervention
Time frame: change between baseline (week 0) and post intervention (week 52)
Perceived Stress Scale (PSS-10)
Change in continuous physiologic data throughout intervention
Time frame: change between baseline (week 0) and post intervention (week 52)
Basis Peak Health Tracking device collects continuous physiologic data (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy)
change in coping abilities post intervention
Time frame: change between baseline (week 0) and post intervention (week 52)
Measure of Coping Status-Revised (MOCS-R)
1 secondary outcome
change in self-reported anxiety and depression
Time frame: change between baseline (week 0) and post intervention (week 52)
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 Dec 2015.
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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 Denninger, M.D./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 Stress, 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 3 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 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?
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 burnout levels post intervention (time frame: change between baseline (week 0) and post intervention (week 52)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 6 Nov 2026.