- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02621788
Evaluation of Mind-body Educational Program to Enhance Resiliency and Reduce Burnout in First Year Residents
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- MGH department of medicine and department of psychiatry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: First Year Residents
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 between baseline (week 0) and post intervention (week 52)
|
|
Change in perceived stress post intervention
Time Frame: change between baseline (week 0) and post intervention (week 52)
|
Perceived Stress Scale (PSS-10)
|
change between baseline (week 0) and post intervention (week 52)
|
|
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 between baseline (week 0) and post intervention (week 52)
|
|
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)
|
change between baseline (week 0) and post intervention (week 52)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in self-reported anxiety and depression
Time Frame: change between baseline (week 0) and post intervention (week 52)
|
Beck Anxiety Inventory (BAI) and Patient Health Questionnaire 9-item
|
change between baseline (week 0) and post intervention (week 52)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Denninger, M.D./PhD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014P000234
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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