Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-29 @ 5:55 PM
Study NCT ID:
NCT04682561
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2020-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STEP: Building Trauma Resilience Among Nurses and Personal Support Workers During and Beyond COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant feedback on their experiences with specific aspects of the STEP program', 'timeFrame': '3 months', 'description': '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'}], 'primaryOutcomes': [{'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', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in healthcare worker resilience using Connor-Davidson Resilience Scale 10 item (CD-RISC 10)', 'timeFrame': 'Baseline, week 8, and 3 months', 'description': '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.'}, {'measure': 'Changes in healthcare worker depression symptoms using Patient Health Questionnaire - 9 item (PHQ-9)', 'timeFrame': 'Baseline, weeks 2-8, and 3 months', 'description': '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.'}, {'measure': 'Changes in healthcare worker anxiety symptoms using Generalized Anxiety Disorder 7-item scale (GAD-7)', 'timeFrame': 'Baseline, weeks 2-8, and 3 months', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Changes in healthcare worker perceived quality of patient care', 'timeFrame': 'Baseline, weeks 2-8, and 3 months', 'description': '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.'}, {'measure': 'Changes in Sheehan Disability Scale (SDS) score', 'timeFrame': 'Baseline, week 4, week 8, and 3 months', 'description': '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).'}, {'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', 'description': 'The LEAPS is a 10-item, self-rated scale that provides a measure of functioning at work.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress Prevention', 'Trauma Coping', 'Psychotherapy', 'COVID-19', 'Nurse', 'Personal Support Worker'], 'conditions': ['Stress', 'Trauma', 'Mental Health Issue', 'Healthcare Workers']}, 'referencesModule': {'references': [{'pmid': '40589165', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Employed as a nurse or personal support worker in Ontario\n* 18 years or older\n* Access to a computer with a camera or a mobile phone with a camera\n* Access to internet\n* Not receiving other psychotherapy concurrently\n* 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.\n* Able to undergo psychotherapy in English\n* Working a minimum of 1 shift per week in a hospital setting or community long term care home\n\nExclusion Criteria:\n\n* Unable to commit to 1-hour weekly psychotherapy session for the 8 weeks duration of the study\n* 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.\n* The presence of cognitive impairment (based on clinical judgment) that would limit consent or understanding of STEP'}, 'identificationModule': {'nctId': 'NCT04682561', 'briefTitle': 'STEP: Building Trauma Resilience Among Nurses and Personal Support Workers During and Beyond COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'The STEP Program: Building Trauma Resilience Among Nurses and Personal Support Workers Across Ontario During and Beyond the COVID-19 Pandemic', 'orgStudyIdInfo': {'id': 'STP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive Trauma Exposure Preparation (STEP) Program', 'description': 'Nurses or personal support workers in Ontario will undergo the STEP Program Psychotherapy', 'interventionNames': ['Behavioral: Supportive Trauma Exposure Preparation Program']}], 'interventions': [{'name': 'Supportive Trauma Exposure Preparation Program', 'type': 'BEHAVIORAL', 'otherNames': ['STEP Program'], 'description': '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.', 'armGroupLabels': ['Supportive Trauma Exposure Preparation (STEP) Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1M8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Sakina Rizvi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Providence Healthcare', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}