STEP: Building Trauma Resilience Among Nurses and Personal Support Workers During and Beyond COVID-19

April 22, 2025 updated by: Unity Health Toronto

The STEP Program: Building Trauma Resilience Among Nurses and Personal Support Workers Across Ontario During and Beyond the COVID-19 Pandemic

The COVID-19 pandemic has amplified the need for skills training and mental health support for healthcare workers who are exposed to the numerous stressors and potential trauma of a high-risk environment. This context is associated with significant impacts on mental health, including depression, anxiety, and post-traumatic stress, with nurses and personal support workers (PSWs) being disproportionately impacted. The proposed STEP program is an intervention that aims to equip nurses and PSWs with the skills and support needed to promote their wellness and navigate the challenges of experiencing trauma in a high-risk, high-stress environment, which has been exacerbated by the pandemic. As such, the STEP intervention has the potential to improve trauma resilience and mental health among nurses and PSW, which may ultimately improve patient care and benefit the hospital system during and even beyond the pandemic. The results from this study will also provide vital insight into promising interventions for healthcare workers that are accessible and scalable.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Conducting work where exposure to trauma occurs requires specific resources and skillsets to manage the immense mental and emotional side effects that can arise. Notably, some nurses and personal support workers (PSWs) deal with trauma on a regular basis, yet often do not have access to such training. It is not surprising, then, that estimates of compassion fatigue and burnout are a staggering 40-60% among healthcare workers, This has been shown to have direct negative effects on personal wellness, patient care, workplace functioning, and the hospital system. Factors that contribute to compassion fatigue include being exposed to another's suffering and stressful work environments. Notably, the COVID-19 pandemic has exacerbated these factors. Furthermore, reduced staffing, increased exposure to trauma, and enhanced perceptions of workplace threat during a pandemic are additional factors that have been shown to significantly impact the mental health and wellness of frontline workers. The need for adequate supports for these frontline workers is essential during and beyond the COVID-19 pandemic. The vast majority of workplace-based organizational interventions for mental health concerns among healthcare workers are delivered in a group setting, primarily focused on psychoeducation and stress reduction techniques.Very few programs include a component involving one-on-one psychotherapy with a licensed therapist, and when offered, it is typically an event-triggered counselling session (i.e., a therapist is made available to a participant in the case where they experience a traumatic stressor at work, such as a bereavement case or managing a patient with traumatic injury. Numerous editorials have been published since the start of the pandemic calling for mental health support for healthcare workers. Among the supportive measures that have been consistently recommended in these reports are the following: provide education on stress and mental health to validate experience; offer stress management, resilience and coping skills training; incorporate debriefing practices; facilitate morale boosting; and offer psychological support through a licensed therapist. We have developed the Supportive Trauma Exposure Preparation (STEP) program to address these unmet critical needs and suggested recommendations. The STEP program is an 8-week psychotherapy intervention designed to teach concepts, skills and coping strategies to healthcare workers with the aim of improving mental health and building resilience in the face of trauma/stress exposure in the healthcare workplace setting. This is a pilot study exploring the effectiveness and feasibility/acceptability of the STEP intervention in reducing burnout, building resilience and improving mental health outcomes for nurses and personal support workers in Ontario. The STEP program has the potential to be widely accessible and fit the demanding work schedule of healthcare workers. Such a program would be useful even beyond the pandemic, given the nature of the healthcare providers' work and what is known about the high prevalence and consequences of stress and compassion fatigue in the pre-COVID-19 pandemic context.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1M8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Employed as a nurse or personal support worker in Ontario
  • 18 years or older
  • Access to a computer with a camera or a mobile phone with a camera
  • Access to internet
  • Not receiving other psychotherapy concurrently
  • Follow-up visits with a psychiatrist or family doctor where a psychotherapeutic modality (e.g. cognitive-behavioural therapy, etc.) is not being used are allowable.
  • Able to undergo psychotherapy in English
  • Working a minimum of 1 shift per week in a hospital setting or community long term care home

Exclusion Criteria:

  • Unable to commit to 1-hour weekly psychotherapy session for the 8 weeks duration of the study
  • Individuals with current high risk for suicide, alcohol or substance use, or active psychosis at the time of screening will not be eligible. Recommendations will be made to appropriate mental health services (e.g., Employee Assistance Program, physician referral to psychiatrist, Ontario COVID-19 Mental Health Network) in order to connect the individual to more targeted support and intervention.
  • The presence of cognitive impairment (based on clinical judgment) that would limit consent or understanding of STEP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supportive Trauma Exposure Preparation (STEP) Program
Nurses or personal support workers in Ontario will undergo the STEP Program Psychotherapy
Behavioral: Supportive Trauma Exposure Preparation Program
The Supportive Trauma Exposure Preparation Program is based on the theory that the ability to set compassionate boundaries will enhance acceptance of the reality of trauma in the workplace, and will also increase the cognitive/emotional/physical energy needed to engage in adaptive emotional strategies in response to trauma exposure. Therefore, the goal of therapy is to learn to set compassionate boundaries and engage with oneself and others from a perspective of self-empowerment and acceptance of life events. Concepts and skills will be addressed through the following modules: 1) understanding of trauma and its effects, 2) personal rights and boundaries, 3) emotional literacy, 4) distress tolerance and emotion regulation skills building, 5) communication skills building, 6) self-compassion and acceptance, and 7) enhancing self-care.
Other Names:
  • STEP Program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from baseline to post-intervention in healthcare worker burnout using Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) burnout subscale
Time Frame: Baseline, week 4, week 8 and 3 months
The ProQOL is a 30-item self-report questionnaire assessing negative and positive effects of helping others who experience suffering and trauma, with subscales for compassion satisfaction, burnout and compassion fatigue. Focus will be paid to the burnout subscale score.
Baseline, week 4, week 8 and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in healthcare worker resilience using Connor-Davidson Resilience Scale 10 item (CD-RISC 10)
Time Frame: Baseline, week 8, and 3 months
The CD-RISC 10 is a 10-item self-report scale used to measure ability to cope with stress and adversity as an indicator of resilience.
Baseline, week 8, and 3 months
Changes in healthcare worker depression symptoms using Patient Health Questionnaire - 9 item (PHQ-9)
Time Frame: Baseline, weeks 2-8, and 3 months
The PHQ-9 is a 9-item self-report scale assessing depression symptoms.Total scores range from 0 to 27, with higher scores reflecting more severe anxiety. Focus will be paid to changes in depression symptom severity.
Baseline, weeks 2-8, and 3 months
Changes in healthcare worker anxiety symptoms using Generalized Anxiety Disorder 7-item scale (GAD-7)
Time Frame: Baseline, weeks 2-8, and 3 months
The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety. Focus will be paid to changes in anxiety severity.
Baseline, weeks 2-8, and 3 months
Changes in healthcare worker compassion satisfaction and secondary traumatic stress subscales of the Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL)
Time Frame: Baseline, week 4, week 8 and 3 months
The ProQOL is a 30-item self-report questionnaire assessing negative and positive effects of helping others who experience suffering and trauma, with subscales for compassion satisfaction, burnout and compassion fatigue.
Baseline, week 4, week 8 and 3 months
Changes in healthcare worker perceived quality of patient care
Time Frame: Baseline, weeks 2-8, and 3 months
This will be assessed by asking participants to rate their perception of the quality of patient care they provided on their last shift, using a 4-point Likert scale.
Baseline, weeks 2-8, and 3 months
Changes in Sheehan Disability Scale (SDS) score
Time Frame: Baseline, week 4, week 8, and 3 months
The SDS is a brief 3-item self-report scale that probes work/school, social, and family/home functioning. Each item is scored from 0 to 10. Total scores range from 0 (unimpaired) to 30 (highly impaired).
Baseline, week 4, week 8, and 3 months
Changes in The Lam Employment Absence and Productivity Scale (LEAPS) score
Time Frame: Baseline, week 2, week 4, week 6, week 8 and 3 months
The LEAPS is a 10-item, self-rated scale that provides a measure of functioning at work.
Baseline, week 2, week 4, week 6, week 8 and 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant feedback on their experiences with specific aspects of the STEP program
Time Frame: 3 months
Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the STEP Program
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Providence Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sakina Rizvi, PhD, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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