CClinicalTrials.gg
CompletedNCT05122910Updated Jan 12, 2023

Assessing the Implementation and Feasibility of the SMART-MR

An interventional study of Stress Management and Resilience Training - Moral Resilience (SMART-MR) program in Moral Injury, sponsored by University of Ottawa. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-12.

Sponsored by University of Ottawa · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of the proposed pilot study is to assess the feasibility and implementation of the SMART-MR program, an integration of stress management, general resilience, and moral resilience skills, with frontline staff who provide direct patient care at The Ottawa Hospital (TOH).

Read the detailed description

Many of the sources of stress facing healthcare workers during the COVID-19 pandemic involve difficult ethical trade-offs that give rise to moral distress. Moral distress has personal consequences for healthcare workers, notably for their mental health, and wider consequences for the organization and health system as a whole as it negatively affects quality of care, patient satisfaction, and the recruitment, retention and satisfaction of staff. Moral resilience refers to the capacity of an individual to sustain or restore their integrity in response to moral adversity and has been raised as a potential way to mitigate moral distress.

The Stress Management and Resilience Training (SMART) program is one of the few evidence-based interventions designed to build resilience in healthcare workers. The SMART program is a brief, neuroscience-based intervention, typically delivered in a single 90-minute session. The structured program teaches self-care skills by developing intentional attention and the ability to reframe potentially stressful situations more quickly.

Recently, a modified version of the existing SMART program, SMART-Moral Resilience (SMART-MR), has been developed with an additional focus on reducing moral distress and building moral resilience for healthcare workers. The synergy of general resilience strategies with focus on the moral/ethical dimensions of clinical practice offer clinicians specific skills to address ethical challenges. We believe implementing the SMART-MR program with frontline staff during the COVID-19 pandemic is warranted. Therefore, we plan to pilot this innovative intervention at TOH to assess its feasibility and implementation.

02

Conditions studied

  • Moral Injury

Keywords

  • Moral Distress
  • Moral Resilience
  • Healthcare workers
  • COVID-19
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 98 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University of Ottawa is the lead sponsor of 123 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • full-time or part-time TOH staff who provide direct patient care, including: attending physicians, nurses, allied health, social workers and spiritual care providers

Exclusion criteria

Exclusion Criteria:

  • TOH staff members who do not provide direct patient care
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    SMART-MR Program

    Participants will participate in the Stress Management and Resilience Training - Moral Resilience (SMART-MR) program.

    Behavioral: Stress Management and Resilience Training - Moral Resilience (SMART-MR) program

Interventions

  • BehavioralStress Management and Resilience Training - Moral Resilience (SMART-MR) program

    All participants will attend an initial 2.5 hour workshop and a 1-hour follow-up workshop. The workshop will include general resilience strategies with a focus on the moral/ethical dimensions of clinical practice to offer participants specific skills to address ethical challenges. In addition to the workshops, there will be follow-up supplemental resources.

06

What researchers measure

Primary outcomes

  1. Change in the Measure of Moral Distress-Health Professionals (MMD-HP)

    27-item scale that measures healthcare professionals' current levels of moral distress. Respondents rate each item on two Likert scales to indicate: how often a situation occurs during their practice (frequency: 0 = never, 4= very frequent) and how distressing it is when it occurs (distressing: 0= none, 4= very distressing). The frequency score (f) is multiplied by the distress score (d) to receive a composite score ("fxd", range 0-16). These scores are summed to create the overall MMD-HP score (ranging from 0-432), with higher scores indicative of higher moral distress.

    Time frame: Baseline, 12 weeks follow-up

  2. Change in the Rushton Moral Resilience Scale (RMRS)

    17-item scale assessing moral resilience in healthcare workers. Respondents rate their level of agreement with each item on a Likert scale from 1 ("disagree") to 4 ("agree"). The items form 4 factors: 1) response to moral adversity; 2) personal integrity; 3) relational integrity; and 4) moral efficacy and a total summative score is calculated.

    Time frame: Baseline, 12 weeks follow-up

Secondary outcomes

  1. Change in the Maslach Burnout Inventory-2 item version (MBI-2 item)

    2 items that capture the emotional exhaustion (i.e., "I feel burned out from my work") and depersonalization (i.e., "I have become more callous toward people since I started this job") domains of burnout. Respondents rate their level of agreement with these items on a scale from 0 (never) to 6 (everyday). A score of \>3 on either item is considered indicative of burnout.

    Time frame: Baseline, 12 weeks follow-up

  2. Change in the Perceived Stress Scale-10 item (PSS-10)

    10-item scale that provides a global measure of perceived stress. Responses range on a 5-point scale from "never" to "very often." A higher score indicates greater stress.

    Time frame: Baseline, 12 weeks follow-up

  3. Change in the Generalized Anxiety Disorder 7-item (GAD-7) scale

    7-item questionnaire that assessed generalized anxiety. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Cut-off scores of 5, 10, and 15 delineate mild, moderate, and severe anxiety, respectively; scores ≤4 correspond to minimal anxiety.

    Time frame: Baseline, 12 weeks follow-up

07

Study locations

1 site
  • The Ottawa Hospital
    Ottawa, Ontario, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05122910
Lead sponsor
University of Ottawa
Responsible party
Edward Spilg (Assistant Professor, University of Ottawa) — Principal investigator
First posted
Nov 17, 2021
Start date
Jul 15, 2022
Primary completion
Dec 15, 2022
Completion
Dec 15, 2022
Last update
Jan 12, 2023

Study contacts

Edward Spilg, MBChB
principal investigator · University of Ottawa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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