Evaluation of Mind-body Educational Program to Enhance Resiliency and Reduce Burnout in First Year Residents

December 1, 2015 updated by: John W. Denninger, MD, PhD, Massachusetts General Hospital

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

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

Interventional

Enrollment (Actual)

85

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
      • Boston, Massachusetts, United States, 02114
        • MGH department of medicine and department of psychiatry

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Denninger, M.D./PhD, Massachusetts General Hospital

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

April 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 4, 2015

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

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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