Stress Clinical Trial
Official title:
The STEP Program: Building Trauma Resilience Among Nurses and Personal Support Workers at Providence Healthcare During and Beyond the COVID-19 Pandemic
NCT number | NCT04682561 |
Other study ID # | STP-01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Employed as a nurse or personal support worker at Unity Health Toronto Providence Healthcare site - 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 at Unity Health Toronto - Providence Healthcare site 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto | Providence Healthcare |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Participant feedback on their experiences with specific aspects of the STEP program | 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 | |
Primary | Changes from baseline to post-intervention (8 weeks) 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 | 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. | Baseline, week 8, and 3 months | |
Secondary | 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. | Baseline, weeks 2-8, and 3 months | |
Secondary | 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. | Baseline, weeks 2-8, and 3 months | |
Secondary | 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. | Baseline, week 4, week 8 and 3 months | |
Secondary | 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. | Baseline, weeks 2-8, and 3 months | |
Secondary | 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). | Baseline, week 4, week 8, and 3 months | |
Secondary | 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. | Baseline, week 2, week 4, week 6, week 8 and 3 months |
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