Clinical trial NCT04682561: STEP: Building Trauma Resilience Among Nurses and Personal Support Workers During and Beyond COVID-19
Official title: The STEP Program: Building Trauma Resilience Among Nurses and Personal Support Workers Across Ontario During and Beyond the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Trauma
Mental Health Issue
Healthcare Workers
Keywords: Stress Prevention
Trauma Coping
Psychotherapy
COVID-19
Nurse
Personal Support Worker
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Providence Healthcare
First posted: 2020-12-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Baseline, week 4, week 8 and 3 months
Secondary outcomes:
measure: Changes in healthcare worker resilience using Connor-Davidson Resilience Scale 10 item (CD-RISC 10)
timeFrame: Baseline, week 8, and 3 months
measure: Changes in healthcare worker depression symptoms using Patient Health Questionnaire - 9 item (PHQ-9)
timeFrame: Baseline, weeks 2-8, and 3 months
measure: Changes in healthcare worker anxiety symptoms using Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Baseline, weeks 2-8, and 3 months
measure: Changes in healthcare worker compassion satisfaction and secondary traumatic stress subscales of the Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL)
timeFrame: Baseline, week 4, week 8 and 3 months
measure: Changes in healthcare worker perceived quality of patient care
timeFrame: Baseline, weeks 2-8, and 3 months
measure: Changes in Sheehan Disability Scale (SDS) score
timeFrame: Baseline, week 4, week 8, and 3 months
measure: Changes in The Lam Employment Absence and Productivity Scale (LEAPS) score
timeFrame: Baseline, week 2, week 4, week 6, week 8 and 3 months
Other outcomes:
measure: Participant feedback on their experiences with specific aspects of the STEP program
timeFrame: 3 months
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Sakina Rizvi, PhD
role: PRINCIPAL_INVESTIGATOR
References: