- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570853
Stress Management and Resiliency Training for Physicians
February 22, 2021 updated by: John W. Denninger, MD, PhD, Massachusetts General Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Newton, Massachusetts, United States, 02462
- Newton Wellesley Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physicians and academic faculty of Brigham and Women's Hospital and Newton-Wellesley Hospital
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention
Participants will receive the 8-week SMART-3RP intervention within a few weeks of enrolling in the study.
|
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.
Other Names:
|
|
NO_INTERVENTION: No Intervention
Participants will not receive the SMART-3RP program and will only complete study questionnaires..
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Approximately 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Denninger, MD, PhD, Benson-Henry Institute for Mind Body Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 9, 2018
Primary Completion (ANTICIPATED)
June 30, 2021
Study Completion (ANTICIPATED)
June 30, 2021
Study Registration Dates
First Submitted
June 18, 2018
First Submitted That Met QC Criteria
June 18, 2018
First Posted (ACTUAL)
June 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P000836
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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