Evaluation of a Mind-body Education Program to Enhance Resiliency and Reduce Burnout in Residents

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

This prospective, waitlist-control study is evaluating the benefits of a stress management and resiliency training program for residents (SMART-R).

The primary aim of this study is to determine whether the SMART-R is effective at increasing coping skills and reducing stress among residents, reflected by changes in constructs such as emotional growth, perceived stress, optimism, and coping styles. 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.

Study Overview

Detailed Description

The investigators adapted the Benson-Henry Institute Stress Management and Resiliency Training Program -- Relaxation Response Resiliency Program (SMART-3RP) to create the SMART-R resident wellness curriculum. The actual SMART-3RP is both a clinical program and research intervention. The three prongs of the SMART-R include 1) elicitation of the relaxation response through mind-body techniques 2) reducing overall stress reactivity and 3) increasing connectedness to self and others.

In a waitlist-control design, the SMART-R was implemented into multiple residents programs at Mass General Hospital, NYU Langone Medical Center, and Weill Cornell Medical College. The primary aim is to evaluate the effectiveness of the SMART-R in increasing coping skills and reducing stress among residents in the participating programs. Participants enrolled will be invited to complete 1) a brief questionnaire before, during (q3months) and after participation in the program (5 questionnaires total). 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.

Additionally, objective indicators of daily workload (page frequency, and quantity of notes authored by a resident during a given period) will help control for residents' schedules and busyness, in evaluating perceived stress, wellbeing and other outcomes.

Study Type

Interventional

Enrollment (Actual)

173

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 Benson-Henry Institute for Mind Body Medicine

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:

  • Residents in the following participating departments: departments of psychiatry, pediatrics, or neurology at MGH, medicine or psychiatry at NYU, or medicine or psychiatry at Cornell

Exclusion Criteria:

  • Not a resident in the participating departments

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Stress Management and Resiliency Training for Residents (SMART-R)
The Stress Management and Resiliency Training Program for residents (SMART-R) is a six-hour intervention delivered over 2 or 3 sessions that teaches residents mind-body skills to reduce stress and enhance coping strategies.
Active Comparator: Waitlist Control
The control group will receive the same intervention (SMART-R) after the experimental group.
The Stress Management and Resiliency Training Program for residents (SMART-R) is a six-hour intervention delivered over 2 or 3 sessions that teaches residents mind-body skills to reduce stress and enhance coping strategies.

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 (July 2015), midpoint (week 25), to 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 (July 2015), midpoint (week 25), to post intervention (week 52)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perceived stress post intervention
Time Frame: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Perceived Stress Scale (PSS-10)
change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Change in continuous physiologic data throughout intervention
Time Frame: change between baseline (July 2015), midpoint (week 25), to 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 (July 2015), midpoint (week 25), to post intervention (week 52)
change in mindfulness post intervention
Time Frame: change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

November 23, 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

  • 2015P000916

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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