NCT02621801

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

November 23, 2015

Last Update Submit

December 1, 2015

Conditions

Resident Burnout

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Change in perceived stress post intervention

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

  • Change in continuous physiologic data throughout intervention

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

  • change in mindfulness post intervention

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Waitlist Control

ACTIVE COMPARATOR

The control group will receive the same intervention (SMART-R) after the experimental group.

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

Interventions

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

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.

InterventionWaitlist Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Not a resident in the participating departments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Benson-Henry Institute for Mind Body Medicine

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Chaukos D, Zebrowski JP, Benson NM, Celik A, Chad-Friedman E, Teitelbaum A, Bernstein C, Cook R, Genfi A, Denninger JW. "One size does not fit all" - lessons learned from a multiple-methods study of a resident wellness curriculum across sites and specialties. BMC Med Educ. 2021 Nov 13;21(1):576. doi: 10.1186/s12909-021-02995-z.

    PMID: 34774057DERIVED

Study Officials

  • John W Denninger, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 23, 2015

First Posted

December 4, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

US(1)