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Traumatic InjuryNCT07275892

Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors

A study testing Cross-continuum Peer Support Program in people with Traumatic Injury and Burns, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Injury, Burns, Amputation
What is being tested?
Cross-continuum Peer Support Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesCanada
Study dates
1 Jan 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • must be able to communicate in English

Who cannot join

  • 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)
  • 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)
  • 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).
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Canada2 sites
  • St. John's Rehab at Sunnybrook

    Toronto, Ontario, M2M 2G1

    Marina Wasilewski, PhD, 416-226-6780 ext. 57957, Marina.Wasilewski@sunnybrook.ca

    Logan Reis, MSc, 416-226-6780 ext. 57897, Logan.Reis@sunnybrook.ca

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Marina Wasilewski, PhD, 416-226-6780 ext. 57957, Marina.Wasilewski@sunnybrook.ca

    Marina Wasilewski, PhD

Other trials in Canada

About this study

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.

Peer 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.

The 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.

Being tested
Cross-continuum Peer Support Program
Keywords
Peer Support, Traumatic Injury
Medical subject headings
Wounds and Injuries, Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cross-continuum Peer Support ProgramBehavioural

    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.

Study groups in NCT07275892
Study groupRoleWhat they receive
Single-arm pilot feasibility studyExperimentalTo evaluate implementation and preliminary impact prior to a future RCT.
Receives: Behavioral: Cross-continuum Peer Support Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of implementing the Peer Support Program

    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.

    • RECRUITMENT (proportion of eligible participants approached who consent-GOAL: ≥50%),
    • WITHDRAWAL (proportion of study participants who withdraw from the study before the end of Phase II (Inpatient Rehabilitation)-GOAL: ≤ 25%)
    • ADHERENCE (proportion of PSP sessions attended by participants-GOAL: ≥60%),
    • RETENTION (proportion of participants who complete the program-GOAL: ≥60%);
    • BASELINE SURVEYS (proportion of surveys completed-GOAL: ≥70%).
    • POST-INTERVENTION SURVEY (proportion of surveys completed-GOAL: ≥60%):
    • SURVEY AT 3 MONTH FOLLOW UP (proportion of surveys completed-GOAL: ≥50%):

    Measured: From recruitment to 3 months post intervention

Secondary outcomes (7)
  1. Community Reintegration - Normal Living Index (RNL) Index

    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.

    Measured: Baseline, up to 2 weeks post intervention, and 3-months post intervention

  2. Coping Self-Efficacy (CSE) - 20-item CSE Scale

    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

    Measured: Baseline, up to 2 weeks post intervention, and 3-months post intervention

  3. Health-Related Quality of Life - The Short-Form 36 (SF-36)

    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.

    Measured: Baseline, up to 2 weeks post intervention, and 3-months post intervention

  4. Post-Traumatic Stress Disorder (PTSD) - The PTSD Checklist-Civilian Version (PCL-C)

    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.

    Measured: Baseline, up to 2 weeks post intervention, and 3-months post intervention

  5. Post-Traumatic Growth - The Post-Traumatic Growth Inventory (PTGI)

    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).

    Measured: Baseline, up to 2 weeks post intervention, and 3-months post intervention

  6. Social Support - The Medical Outcomes Study Social Support Survey (MOS-SS)

    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.

    Measured: Baseline, up to 2 weeks post intervention, and 3-months post intervention

  7. Loneliness and Social Isolation -The UCLA 3-Item Loneliness Scale

    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.

    Measured: Baseline, up to 2 weeks post intervention, and 3-months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Trauma survivors.
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07275892
Sponsor's protocol ID
6905
Status last verified
Dec 2025
First submitted
4 Sep 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To maintain patient confidentiality.

Publications

  • 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.

    PubMed 12605954
  • Braun V, Clarke V. Reflecting on reflexive thematic analysis. Qualitative research in sport, exercise and health. 2019;11(4):589-597

  • Braun V, Clarke V. One size fits all? What counts as quality practice in (reflexive) thematic analysis? Qualitative research in psychology. 2021;18(3):328-352

  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006/01/01 2006;3(2):77-101. doi:10.1191/1478088706qp063oa

  • Hitzig SL, Gotlib Conn L, Guilcher SJT, Cimino SR, Robinson LR. Understanding the role of the physiatrist and how to improve the continuum of care for trauma patients: a qualitative study. Disabil Rehabil. 2021 Oct;43(20):2846-2853. doi: 10.1080/09638288.2020.1719215. Epub 2020 Feb 4.

    PubMed 32017865
  • Wasilewski MB, Stinson JN, Webster F, Cameron JI. Using Twitter to recruit participants for health research: An example from a caregiving study. Health Informatics J. 2019 Dec;25(4):1485-1497. doi: 10.1177/1460458218775158. Epub 2018 May 30.

    PubMed 29843545
  • Thorogood N, Green J. Qualitative Methods for Health Research. SAGE Publications Ltd.; 2009

  • Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.

    PubMed 34812790
  • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

    PubMed 27777223
  • Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

    PubMed 18504506
  • Ljungvall H, Ekselius L, Asenlof P. Reliability, construct validity, and factorial structure of a Swedish version of the medical outcomes study social support survey (MOS-SSS) in patients with chronic pain. Scand J Pain. 2023 Sep 18;24(1). doi: 10.1515/sjpain-2023-0002. eCollection 2024 Jan 1.

    PubMed 37712773
  • Merino-Soto C, Nunez Benitez MA, Dominguez-Guedea MT, Toledano-Toledano F, Moral de la Rubia J, Astudillo-Garcia CI, Rivera-Rivera L, Leyva-Lopez A, Angulo-Ramos M, Flores Laguna OA, Hernandez-Salinas G, Rodriguez Castro JH, Gonzalez Pena OI, Garduno Espinosa J. Medical outcomes study social support survey (MOS-SSS) in patients with chronic disease: A psychometric assessment. Front Psychiatry. 2023 Jan 11;13:1028342. doi: 10.3389/fpsyt.2022.1028342. eCollection 2022.

    PubMed 36713918
  • Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.

    PubMed 8827649
  • Wilkins KC, Lang AJ, Norman SB. Synthesis of the psychometric properties of the PTSD checklist (PCL) military, civilian, and specific versions. Depress Anxiety. 2011 Jul;28(7):596-606. doi: 10.1002/da.20837. Epub 2011 Jun 16.

    PubMed 21681864
  • Pan SL, Liang HW, Hou WH, Yeh TS. Responsiveness of SF-36 and Lower Extremity Functional Scale for assessing outcomes in traumatic injuries of lower extremities. Injury. 2014 Nov;45(11):1759-63. doi: 10.1016/j.injury.2014.05.022. Epub 2014 May 28.

    PubMed 24938677

Questions about this trial

What is this clinical trial studying?

A study testing Cross-continuum Peer Support Program in people with Traumatic Injury and Burns, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marina Wasilewski, PhD (416-226-6780 ext. 57957, Marina.Wasilewski@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of implementing the Peer Support Program (time frame: From recruitment to 3 months post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07275892, which also lists 81 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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