NCT04682561

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

December 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 25, 2025

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

December 22, 2020

Last Update Submit

April 22, 2025

Conditions

Keywords

Stress PreventionTrauma CopingPsychotherapyCOVID-19NursePersonal Support Worker

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    Baseline, week 8, and 3 months

  • Changes in healthcare worker depression symptoms using Patient Health Questionnaire - 9 item (PHQ-9)

    Baseline, weeks 2-8, and 3 months

  • Changes in healthcare worker anxiety symptoms using Generalized Anxiety Disorder 7-item scale (GAD-7)

    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)

    Baseline, week 4, week 8 and 3 months

  • Changes in healthcare worker perceived quality of patient care

    Baseline, weeks 2-8, and 3 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Participant feedback on their experiences with specific aspects of the STEP program

    3 months

Study Arms (1)

Supportive Trauma Exposure Preparation (STEP) Program

EXPERIMENTAL

Nurses or personal support workers in Ontario will undergo the STEP Program Psychotherapy

Behavioral: Supportive Trauma Exposure Preparation Program

Interventions

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.

Also known as: STEP Program
Supportive Trauma Exposure Preparation (STEP) Program

Eligibility Criteria

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

You may qualify if:

  • Employed as a nurse or personal support worker in Ontario
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Wounds and InjuriesCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sakina Rizvi, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 23, 2020

Study Start

January 1, 2022

Primary Completion

August 30, 2024

Study Completion

December 20, 2024

Last Updated

April 25, 2025

Record last verified: 2024-08

Locations