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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621788
• Other study ID #: 2014P000234
• Status: Completed
• Phase: N/A
• First received: May 14, 2015
• Last updated: December 1, 2015
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Stress Management and Resiliency Training for Residents (SMART-R)
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.

Locations

Country	Name	City	State
United States	MGH department of medicine and department of psychiatry	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in burnout levels post intervention	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)	No
Primary	Change in perceived stress post intervention	Perceived Stress Scale (PSS-10)	change between baseline (week 0) and post intervention (week 52)	No
Primary	Change in continuous physiologic data throughout intervention	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)	No
Primary	change in coping abilities post intervention	Measure of Coping Status-Revised (MOCS-R)	change between baseline (week 0) and post intervention (week 52)	No
Secondary	change in self-reported anxiety and depression	Beck Anxiety Inventory (BAI) and Patient Health Questionnaire 9-item	change between baseline (week 0) and post intervention (week 52)	No