Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-01 @ 1:50 PM
Study NCT ID:
NCT07275892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002056', 'term': 'Burns'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Trauma survivors.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of implementing the Peer Support Program', 'timeFrame': 'From recruitment to 3 months post intervention', 'description': 'To determine the feasibility of implementing the Peer Support Program (PSP) for trauma survivors. We will measure the criteria below to establish feasibility. These feasibility goals were established with reference to another study our group conducted aimed at assessing the feasibility of a novel psychosocial group intervention for amputees.\n\n* RECRUITMENT (proportion of eligible participants approached who consent-GOAL: ≥50%),\n* WITHDRAWAL (proportion of study participants who withdraw from the study before the end of Phase II (Inpatient Rehabilitation)-GOAL: ≤ 25%)\n* ADHERENCE (proportion of PSP sessions attended by participants-GOAL: ≥60%),\n* RETENTION (proportion of participants who complete the program-GOAL: ≥60%);\n* BASELINE SURVEYS (proportion of surveys completed-GOAL: ≥70%).\n* POST-INTERVENTION SURVEY (proportion of surveys completed-GOAL: ≥60%):\n* SURVEY AT 3 MONTH FOLLOW UP (proportion of surveys completed-GOAL: ≥50%):'}], 'secondaryOutcomes': [{'measure': 'Community Reintegration - Normal Living Index (RNL) Index', 'timeFrame': 'Baseline, up to 2 weeks post intervention, and 3-months post intervention', 'description': 'The 11-item Reintegration to Normal Living Index (RNL) Index covers areas such as involvement in recreational and social activities, perceived ability to move within the community, and the degree of comfort people have with their relationships. It is a valid and reliable tool for assessing participation in various populations. Scores range from 0 to 110, with a higher score indicating a higher level of community reintegration.'}, {'measure': 'Coping Self-Efficacy (CSE) - 20-item CSE Scale', 'timeFrame': 'Baseline, up to 2 weeks post intervention, and 3-months post intervention', 'description': "The 20-item CSE Scale66 is a coping self-efficacy scale that has a robust factor structure across different types of post-traumatic events, making it especially suitable for use in various trauma populations. For each item, respondents rate their perceived efficacy on dealing with different consequences of trauma on a 7-point scale (e.g. 'resuming normal life'; 'being optimistic since the event'). Scores range from 20 (low self-efficacy) to 140 (high self-efficacy). The internal consistency of the scale has been found to be excellent across three panel waves of data in persons who had experienced a traumatic event in the previous two years"}, {'measure': 'Health-Related Quality of Life - The Short-Form 36 (SF-36)', 'timeFrame': 'Baseline, up to 2 weeks post intervention, and 3-months post intervention', 'description': 'The Short-Form 36 (SF-36) is the most widely used generic health-related QoL instrument, including Neuro-musculoskeletal injuries, which measures 8 multi-item dimensions of health: physical functioning, social functioning, role limitations due to physical and emotional problems, mental health, energy/vitality, pain, and general health perception. Scores range from 0 to 100 on each domain, with lower scores indicating poorer function. These eight dimensions are summarized into a physical and mental health summary score. The SF-36 is sensitive to changes in functioning over time, and has demonstrated clinically meaningful, albeit modest, change in trauma patients.'}, {'measure': 'Post-Traumatic Stress Disorder (PTSD) - The PTSD Checklist-Civilian Version (PCL-C)', 'timeFrame': 'Baseline, up to 2 weeks post intervention, and 3-months post intervention', 'description': 'The PTSD Checklist-Civilian Version (PCL-C) is a standardized 17-item self-report rating scale for PTSD that is well-validated across different populations. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point scale, with higher scores indicating more severe levels of PTSD.'}, {'measure': 'Post-Traumatic Growth - The Post-Traumatic Growth Inventory (PTGI)', 'timeFrame': 'Baseline, up to 2 weeks post intervention, and 3-months post intervention', 'description': 'The Post-Traumatic Growth Inventory (PTGI) is a 21-item scale assessing positive outcomes reported by those who have experienced traumatic events. Items are scored on a 6-point scale and scores range from 0 to 105, with higher scores indicating greater levels of growth. It has good levels of internal consistency reliability (α=.90) and 2-month test-retest stability (r =.71).'}, {'measure': 'Social Support - The Medical Outcomes Study Social Support Survey (MOS-SS)', 'timeFrame': 'Baseline, up to 2 weeks post intervention, and 3-months post intervention', 'description': 'The Medical Outcomes Study Social Support Survey (MOS-SS) is a 19-item measure of perceived social support across four subscales: emotional/information support; tangible support; affectionate support; and positive social interaction. Questions are answered on a 5-point scale ranging from "none of the time" to "all of the time", with higher scores indicating more support. The MOS-SS has very good internal consistency across populations including chronic disease and chronic pain.'}, {'measure': 'Loneliness and Social Isolation -The UCLA 3-Item Loneliness Scale', 'timeFrame': 'Baseline, up to 2 weeks post intervention, and 3-months post intervention', 'description': 'The UCLA 3-Item Loneliness Scale measures three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation. Items are scored from 1 (hardly ever) to 3 (often), with higher scores indicating greater loneliness and isolation. It has satisfactory reliability and both concurrent and discriminant validity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peer Support', 'Traumatic Injury'], 'conditions': ['Traumatic Injury', 'Burns', 'Amputation', 'Mental Health Outcomes']}, 'referencesModule': {'references': [{'pmid': '12605954', 'type': 'BACKGROUND', 'citation': 'Dennis CL. Peer support within a health care context: a concept analysis. Int J Nurs Stud. 2003 Mar;40(3):321-32. doi: 10.1016/s0020-7489(02)00092-5.'}, {'type': 'BACKGROUND', 'citation': 'Braun V, Clarke V. Reflecting on reflexive thematic analysis. Qualitative research in sport, exercise and health. 2019;11(4):589-597'}, {'type': 'BACKGROUND', 'citation': 'Braun V, Clarke V. One size fits all? What counts as quality practice in (reflexive) thematic analysis? 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The global burden of injury: incidence, mortality, disability-adjusted life years and time trends from the Global Burden of Disease study 2013. Inj Prev. 2016 Feb;22(1):3-18. doi: 10.1136/injuryprev-2015-041616. Epub 2015 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'Traumatic injuries from events like car crashes, falls, or fires are a leading cause of disability. Survivors often face not only physical challenges but also long-lasting pain, mental health challenges and difficulty returning to work and family life. Although medical care focuses on physical recovery, survivors frequently report that their emotional and social needs are overlooked and unmet.\n\nPeer support-guidance from people who have lived through similar injuries-can reduce distress and improve coping. However, no programs in Canada currently provide peer support to trauma survivors across their recovery journey, from hospital to rehabilitation to community living.\n\nThe investigators worked with trauma survivors, caregivers, and healthcare providers to co-design a Peer Support Program (PSP) that offers support throughout these stages. This pilot study will test whether the program is feasible and acceptable, and explore its early impact on recovery. Results will guide a future larger trial to expand peer support in trauma care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult patients (18 years+) who have experienced an unintentional traumatic injury resulting in hospitalization at Sunnybrook and who will be discharged to inpatient rehabilitation at St. John's Rehab after acute care.\n* must be able to communicate in English\n\nExclusion Criteria:\n\n* patients who experienced: a) an intentional self-harm injury (because self-harm suggests a history of mental health issues prior to the trauma requiring specific psychiatric supports)\n* patients who experienced: an injury caused by an intimate partner (because these injuries are typically underpinned by chronic exposure to domestic violence which requires interventions that promote patient safety and interrupt the pattern of violence)\n* patients who experienced: a violently-acquired injury (as this patient population already receives specific clinical and social support through Sunnybrook's BReAking the Cycle of Violence with Empathy (BRAVE) program).\n* patients with substantial cognitive impairment and a history of substance misuse if their HCPs indicate that either condition will impede the their ability to provide informed consent and/or participate safely in the trial"}, 'identificationModule': {'nctId': 'NCT07275892', 'briefTitle': 'Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors', 'orgStudyIdInfo': {'id': '6905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-arm pilot feasibility study', 'description': 'To evaluate implementation and preliminary impact prior to a future RCT.', 'interventionNames': ['Behavioral: Cross-continuum Peer Support Program']}], 'interventions': [{'name': 'Cross-continuum Peer Support Program', 'type': 'BEHAVIORAL', 'description': 'Trained trauma-survivor peer supporters (n=4), supported by a research team member; peers complete a 5-session training covering trauma-informed communication, boundaries, crisis de-escalation, self-care, and secondary trauma. Trauma survivors will be recruited in acute care and have the option to meeting once with a trained peer supporter prior to discharge to inpatient rehabilitation. In in-patient rehab they will attend 1 hour peer support group sessions facilitated by the trained peer supporters twice a week for a total of 3 weeks. Once discharged the community, they will attend 1 hour peer support group sessions facilitated by the trained peer supporters once a week for a total of 12 weeks.', 'armGroupLabels': ['Single-arm pilot feasibility study']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M2M 2G1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Marina Wasilewski, PhD', 'role': 'CONTACT', 'email': 'Marina.Wasilewski@sunnybrook.ca', 'phone': '416-226-6780', 'phoneExt': '57957'}, {'name': 'Logan Reis, MSc', 'role': 'CONTACT', 'email': 'Logan.Reis@sunnybrook.ca', 'phone': '416-226-6780', 'phoneExt': '57897'}, {'name': 'Marina Wasilewski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. John's Rehab at Sunnybrook", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Marina Wasilewski, PhD', 'role': 'CONTACT', 'email': 'Marina.Wasilewski@sunnybrook.ca', 'phone': '416-226-6780', 'phoneExt': '57957'}, {'name': 'Marina Wasilewski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Marina Wasilewski, PhD', 'role': 'CONTACT', 'email': 'Marina.Wasilewski@sunnybrook.ca', 'phone': '416-226-6780', 'phoneExt': '57957'}, {'name': 'Logan Reis, MsC', 'role': 'CONTACT', 'email': 'Logan.Reis@sunnybrook.ca', 'phone': '416-226-6780', 'phoneExt': '57897'}], 'overallOfficials': [{'name': 'Marina Wasilewski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. John's Rehab Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To maintain patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Marina Wasilewski', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}