Burnout, ProfessionalNCT03570853
Stress Management and Resiliency Training for Physicians
A study testing SMART-3RP in people with Burnout, Professional and Stress, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This study is to evaluate the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Stress
- What is being tested?
- SMART-3RP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2018to 30 Jun 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
- Physicians and academic faculty of Brigham and Women's Hospital and Newton-Wellesley Hospital
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Newton Wellesley Hospital
Newton, Massachusetts, 02462
About this study
This study is to evaluate the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.
Read the detailed description
Burnout is a serious problem in healthcare, resulting in absenteeism, decreased job satisfaction, decreased empathy, anxiety, depression, increased medical errors and decreased patient satisfaction. A growing number of studies have demonstrated that programs incorporating mind-body practices increase resilience in healthcare providers and can reduce burnout and perceived stress while increasing empathy. The Benson-Henry Institute for Mind Body Medicine (BHI) has developed a clinical program for patients known as the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP or SMART Program for short). This study is to evaluate the effect of the SMART-3RP on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.
- Conditions
- Burnout, Professional, Stress
- Being tested
- SMART-3RP
- Keywords
- Resiliency
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART-3RPBehavioural
Also called Stress Management and Resiliency Training Relaxation Response Resiliency Program, Stress Management and Resiliency Training Program (SMART Program)
This is an 8-week, multimodal resiliency program that targets stress with 4 main components: mind-body skills (participants learn a variety of meditation techniques, mini relaxations, walking meditation, and yoga), traditional stress management techniques, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive reappraisal and adaptive coping skills (borrowed from cognitive behavioral therapy, acceptance and commitment therapy, and positive psychology). The program consists of 8, 1.5 hour sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive the 8-week SMART-3RP intervention within a few weeks of enrolling in the study. Receives: Behavioral: SMART-3RP |
| No Intervention | No intervention | Participants will not receive the SMART-3RP program and will only complete study questionnaires.. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived stress: pre-program vs. post-program
Change in score on the perceived stress scale - 10 item instrument (PSS-10) from baseline to completion of the group.
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start9 Jul 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
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, MD, PhD, Principal investigator, Benson-Henry Institute for Mind Body Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570853
- Sponsor's protocol ID
- 2018P000836
- Status last verified
- Feb 2021
- First submitted
- 18 Jun 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management and Resiliency Training for Physicians
- ClinicalTrials.gov ID
- NCT03570853
- Acronym / sponsor ID
- 2018P000836
- Conditions
- Burnout, Professional, Stress
- Keywords
- Resiliency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 27 Jun 2018 (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.
This study is to evaluate the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.
Detailed description
Burnout is a serious problem in healthcare, resulting in absenteeism, decreased job satisfaction, decreased empathy, anxiety, depression, increased medical errors and decreased patient satisfaction. A growing number of studies have demonstrated that programs incorporating mind-body practices increase resilience in healthcare providers and can reduce burnout and perceived stress while increasing empathy. The Benson-Henry Institute for Mind Body Medicine (BHI) has developed a clinical program for patients known as the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP or SMART Program for short). This study is to evaluate the effect of the SMART-3RP on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SMART-3RPParticipants will receive the 8-week SMART-3RP intervention within a few weeks of enrolling in the study. |
| No Intervention | No intervention | –Participants will not receive the SMART-3RP program and will only complete study questionnaires.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians and academic faculty of Brigham and Women's Hospital and Newton-Wellesley Hospital
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| SMART-3RPAlso: Stress Management and Resiliency Training Relaxation Response Resiliency Program, Stress Management and Resiliency Training Program (SMART Program)This is an 8-week, multimodal resiliency program that targets stress with 4 main components: mind-body skills (participants learn a variety of meditation techniques, mini relaxations, walking meditation, and yoga), traditional stress management techniques, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive reappraisal and adaptive coping skills (borrowed from cognitive behavioral therapy, acceptance and commitment therapy, and positive psychology). The program consists of 8, 1.5 hour sessions. | Behavioural | Intervention |
Primary outcome
Change in perceived stress: pre-program vs. post-program
Time frame: Approximately 2 months
Change in score on the perceived stress scale - 10 item instrument (PSS-10) from baseline to completion of the group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- 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.
John Denninger, MD, PhD principal investigator
Benson-Henry Institute for Mind Body Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART-3RP in people with Burnout, Professional and Stress, run by Massachusetts General Hospital at 2 sites 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 perceived stress: pre-program vs. post-program (time frame: Approximately 2 months). 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 24 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.