StressNCT04682561
STEP: Building Trauma Resilience Among Nurses and Personal Support Workers During and Beyond COVID-19
A study testing Supportive Trauma Exposure Preparation Program in people with Stress and Trauma, run by Unity Health Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Trauma, Mental Health Issue
- What is being tested?
- Supportive Trauma Exposure Preparation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Trauma, Mental Health Issue, Healthcare Workers
- Being tested
- Supportive Trauma Exposure Preparation Program
- Keywords
- Stress Prevention, Trauma Coping, Psychotherapy, COVID-19, Nurse, Personal Support Worker
- Medical subject headings
- Wounds and Injuries, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Trauma Exposure Preparation ProgramBehavioural
Also called STEP 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.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Trauma Exposure Preparation (STEP) Program | Experimental | Nurses or personal support workers in Ontario will undergo the STEP Program Psychotherapy Receives: Behavioral: Supportive Trauma Exposure Preparation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to post-intervention in healthcare worker burnout using Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) burnout subscale
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.
Measured: Baseline, week 4, week 8 and 3 months
Secondary outcomes (7)
Changes in healthcare worker resilience using Connor-Davidson Resilience Scale 10 item (CD-RISC 10)
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.
Measured: Baseline, week 8, and 3 months
Changes in healthcare worker depression symptoms using Patient Health Questionnaire - 9 item (PHQ-9)
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.
Measured: Baseline, weeks 2-8, and 3 months
Changes in healthcare worker anxiety symptoms using Generalized Anxiety Disorder 7-item scale (GAD-7)
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.
Measured: 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)
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.
Measured: Baseline, week 4, week 8 and 3 months
Changes in healthcare worker perceived quality of patient care
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.
Measured: Baseline, weeks 2-8, and 3 months
Changes in Sheehan Disability Scale (SDS) score
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).
Measured: Baseline, week 4, week 8, and 3 months
Changes in The Lam Employment Absence and Productivity Scale (LEAPS) score
The LEAPS is a 10-item, self-rated scale that provides a measure of functioning at work.
Measured: Baseline, week 2, week 4, week 6, week 8 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Jan 2022
- Primary completion30 Aug 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 month, within-subjects longitudinal study, with each participant receiving 8 weekly sessions of the STEP psychotherapy intervention designed to help mitigate the effects of stress and trauma on their ability to provide patient care.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Healthcare
- Responsible party
- Sponsor
- Investigators
- Sakina Rizvi, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682561
- Sponsor's protocol ID
- STP-01
- Status last verified
- Aug 2024
- First submitted
- 22 Dec 2020
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lalovic A, Hyde M, Bergmans Y, Kiriakidis A, Ebegbare N, Verduyn A, Rizvi SJ. Enhancing Trauma Resilience in Nurses and Personal Support Workers: A Feasibility Study of an 8-Week Supportive Trauma Exposure Preparation Intervention. Can J Nurs Res. 2025 Dec;57(4):580-591. doi: 10.1177/08445621251354918. Epub 2025 Jun 30.
PubMed 40589165
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STEP Program: Building Trauma Resilience Among Nurses and Personal Support Workers Across Ontario During and Beyond the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04682561
- Acronym / sponsor ID
- STP-01
- Conditions
- Stress, Trauma, Mental Health Issue, Healthcare Workers
- Keywords
- Stress Prevention, Trauma Coping, Psychotherapy, COVID-19, Nurse, Personal Support Worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Providence Healthcare
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 month, within-subjects longitudinal study, with each participant receiving 8 weekly sessions of the STEP psychotherapy intervention designed to help mitigate the effects of stress and trauma on their ability to provide patient care.
| Arm | Type | Receives |
|---|---|---|
| Supportive Trauma Exposure Preparation (STEP) Program | Experimental | Behavioral: Supportive Trauma Exposure Preparation ProgramNurses or personal support workers in Ontario will undergo the STEP Program Psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive Trauma Exposure Preparation ProgramAlso: STEP ProgramThe 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. | Behavioural | Supportive Trauma Exposure Preparation (STEP) Program |
Primary outcome
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.
7 secondary outcomes
Changes in healthcare worker resilience using Connor-Davidson Resilience Scale 10 item (CD-RISC 10)
Time frame: 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
Changes in healthcare worker anxiety symptoms using Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: 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
Changes in healthcare worker perceived quality of patient care
Time frame: Baseline, weeks 2-8, and 3 months
Changes in Sheehan Disability Scale (SDS) score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Derived from this study: PubMed 40589165Lalovic A, Hyde M, Bergmans Y, Kiriakidis A, Ebegbare N, Verduyn A, Rizvi SJ. Enhancing Trauma Resilience in Nurses and Personal Support Workers: A Feasibility Study of an 8-Week Supportive Trauma Exposure Preparation Intervention. Can J Nurs Res. 2025 Dec;57(4):580-591. doi: 10.1177/08445621251354918. Epub 2025 Jun 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sakina Rizvi, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Trauma Exposure Preparation Program in people with Stress and Trauma, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.