NCT02621788

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

May 14, 2015

Last Update Submit

December 1, 2015

Conditions

Keywords

mind/body medicine3RPstress managementresident burnout

Outcome Measures

Primary Outcomes (4)

  • 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)

  • Change in perceived stress post intervention

    Perceived Stress Scale (PSS-10)

    change between baseline (week 0) and post intervention (week 52)

  • 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)

  • change in coping abilities post intervention

    Measure of Coping Status-Revised (MOCS-R)

    change between baseline (week 0) and post intervention (week 52)

Secondary Outcomes (1)

  • change in self-reported anxiety and depression

    change between baseline (week 0) and post intervention (week 52)

Study Arms (1)

First Year Residents

EXPERIMENTAL

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

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

Interventions

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.

First Year Residents

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Massachusetts General Hospital first year resident in Department of Medicine or Department of Psychiatry
  • years of age or older
  • consenting to participate in 3RP-1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH department of medicine and department of psychiatry

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • John Denninger, M.D./PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

May 14, 2015

First Posted

December 4, 2015

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations