- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02621801
Evaluation of a Mind-body Education Program to Enhance Resiliency and Reduce Burnout in Residents
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- MGH Benson-Henry Institute for Mind Body Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Active Comparator: Waitlist Control
The control group will receive the same intervention (SMART-R) after the experimental group.
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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)
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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)
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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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 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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