NCT04384861

Brief Summary

Background Definitions of resilience vary according to the context in which it is discussed. It is often considered from the perspective of the individual. Connor \& Davidsondescribe it as "the personal qualities that enable an individual to thrive in the face of adversity". Various studies have now shown a link between individual resilience and various mental health outcomes such as burnout, secondary traumatic stress, depression, and anxiety. In a systematic review by Fox et al., 22 studies explicitly stated an aim of improving physician resilience. However, there was a lack of consensus concerning the conceptual understanding of resilience with low methodological rigour of the included studies. Research Questions

  1. 1.What effect will an evidence-based resilience building intervention have on levels of resilience, stress and subjective happiness in Department of Medicine Faculty at the University of Ottawa?
  2. 2.How might implementation of an evidence-based resilience building intervention on Department of Medicine faculty, lead to the development of a community of practice for physician wellness in the Department of Medicine at The Ottawa Hospital/University of Ottawa?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

April 28, 2020

Last Update Submit

May 8, 2023

Conditions

Keywords

Professional BurnoutWellnessEmotional StressResilience

Outcome Measures

Primary Outcomes (4)

  • Change in Connor-Davidson Resilience Scale (CD-RISC) scores

    * utilized for the assessment of the self-reported measures of resilience and the ability to cope with adversity * 25 questions; responses from 0 to 4 * minimum total score: 0; maximum total score 100; higher scores indicative of greater levels of resilience.

    Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

  • Change in Perceived Stress Scale (PSS) scores

    * utilized to assess participant's level of perceived stress * 10 questions; responses from 0 to 4 * minimum total score: 0; maximum total score: 40; higher scores indicative of higher perceived chronic levels of stress

    Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

  • Change in Generalized Anxiety Disorder-7 (GAD-7) scale scores

    * utilized in the assessment of anxiety * 7 questions; responses from 0 to 3 * minimum total score: 0; maximum total score 21; higher scores indicative of severe anxiety symptoms

    Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

  • Change in Subjective Happiness Scale (SHS) scores

    * utilized to assess participant's level of global subjective happiness * 4 questions; responses from 1 to 7 * minimum total score: 4; maximum total score 28; higher scores indicative of higher levels of subjective happiness

    Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

Study Arms (2)

ACTIVE

EXPERIMENTAL

The ACTIVE arm of the project received the Mayo Clinic SMART training (1 two-hour in-person workshop) and access to the Mayo Clinic's SMART eLearning Support study modules (4 x 45 minute modules in weeks 1-4; 20 x 10 minute modules weeks 5-24)

Behavioral: Mayo Clinic SMART program (Stress Management and Resilience Training)

CONTROL

NO INTERVENTION

The CONTROL did not receive any interventions.

Interventions

The SMART program included a workshop and ongoing eLearning Support. The learning objectives of the workshop are: (1) learn the neuroscience and behavioural aspects of human experience, particularly with respect to stress, resiliency, performance and wellness and (2) learn practical approaches to enhance engagement and emotional intelligence and thereby decrease stress and anxiety, increase resilience, enhance performance, and improve relationships. The goal of the eLearning support is to support and reinforce the messages and techniques delivered in the 2-hour workshop.

Also known as: Mayo Clinic SMART eLearning Support
ACTIVE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a full-time physician within the Department of Medicine at the Ottawa Hospital

You may not qualify if:

  • part-time physicians; those external to the department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (9)

  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

    PMID: 12964174BACKGROUND
  • Mak WW, Ng IS, Wong CC. Resilience: enhancing well-being through the positive cognitive triad. J Couns Psychol. 2011 Oct;58(4):610-7. doi: 10.1037/a0025195.

    PMID: 21895357BACKGROUND
  • Mealer M, Jones J, Newman J, McFann KK, Rothbaum B, Moss M. The presence of resilience is associated with a healthier psychological profile in intensive care unit (ICU) nurses: results of a national survey. Int J Nurs Stud. 2012 Mar;49(3):292-9. doi: 10.1016/j.ijnurstu.2011.09.015. Epub 2011 Oct 5.

    PMID: 21974793BACKGROUND
  • McGarry S, Girdler S, McDonald A, Valentine J, Lee SL, Blair E, Wood F, Elliott C. Paediatric health-care professionals: relationships between psychological distress, resilience and coping skills. J Paediatr Child Health. 2013 Sep;49(9):725-32. doi: 10.1111/jpc.12260. Epub 2013 Jul 1.

    PMID: 23808920BACKGROUND
  • Lü W, Wang Z, Liu Y, Zhang H. Resilience as a mediator between extraversion, neuroticism and happiness, PA and NA. Personal Individ Differ. 2014;63:128-133

    BACKGROUND
  • Fox S, Lydon S, Byrne D, Madden C, Connolly F, O'Connor P. A systematic review of interventions to foster physician resilience. Postgrad Med J. 2018 Mar;94(1109):162-170. doi: 10.1136/postgradmedj-2017-135212. Epub 2017 Oct 10.

    PMID: 29018095BACKGROUND
  • Sood A, Sharma V, Schroeder DR, Gorman B. Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial. Explore (NY). 2014 Nov-Dec;10(6):358-63. doi: 10.1016/j.explore.2014.08.002. Epub 2014 Aug 21.

    PMID: 25443423BACKGROUND
  • Charmaz K. Constructing Grounded Theory. Sage; 2014. https://us.sagepub.com/en-us/nam/constructing-grounded-theory/book235960. Accessed December 21, 2017

    BACKGROUND
  • Spilg EG, Kuk H, Ananny L, McNeill K, LeBlanc V, Bauer BA, Sood A, Wells PS. The impact of Stress Management and Resilience Training (SMART) on academic physicians during the implementation of a new Health Information System: An exploratory randomized controlled trial. PLoS One. 2022 Apr 22;17(4):e0267240. doi: 10.1371/journal.pone.0267240. eCollection 2022. Erratum In: PLoS One. 2024 Apr 11;19(4):e0302288. doi: 10.1371/journal.pone.0302288.

MeSH Terms

Conditions

Burnout, ProfessionalStress, Psychological

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Edward Spilg, MD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Because the SMART training \& Focus Groups were done in groups, ACTIVE participants were not masked from each other or the Investigators. Because the CONTROL participants did not attend any in-person meetings, they were masked from each other, the ACTIVE participants and the Investigator.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Physician volunteers were first divided by gender and then randomly assigned to either the CONTROL (no SMART Wellness training) or ACTIVE (received SMART Wellness training) arms of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Research Chair in Physician Wellness

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 12, 2020

Study Start

July 31, 2018

Primary Completion

September 16, 2019

Study Completion

December 13, 2019

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations