Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors

December 8, 2025 updated by: Marina Wasilewski, Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Marina Wasilewski, PhD
      • Toronto, Ontario, Canada, M2M 2G1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-arm pilot feasibility study
To evaluate implementation and preliminary impact prior to a future RCT.
Behavioral: Cross-continuum Peer Support Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of implementing the Peer Support Program
Time Frame: From recruitment to 3 months post intervention

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%):
From recruitment to 3 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Community Reintegration - Normal Living Index (RNL) Index
Time Frame: Baseline, up to 2 weeks post intervention, and 3-months post intervention
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.
Baseline, up to 2 weeks post intervention, and 3-months post intervention
Coping Self-Efficacy (CSE) - 20-item CSE Scale
Time Frame: Baseline, up to 2 weeks post intervention, and 3-months post intervention
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
Baseline, up to 2 weeks post intervention, and 3-months post intervention
Health-Related Quality of Life - The Short-Form 36 (SF-36)
Time Frame: Baseline, up to 2 weeks post intervention, and 3-months post intervention
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.
Baseline, up to 2 weeks post intervention, and 3-months post intervention
Post-Traumatic Stress Disorder (PTSD) - The PTSD Checklist-Civilian Version (PCL-C)
Time Frame: Baseline, up to 2 weeks post intervention, and 3-months post intervention
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.
Baseline, up to 2 weeks post intervention, and 3-months post intervention
Post-Traumatic Growth - The Post-Traumatic Growth Inventory (PTGI)
Time Frame: Baseline, up to 2 weeks post intervention, and 3-months post intervention
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).
Baseline, up to 2 weeks post intervention, and 3-months post intervention
Social Support - The Medical Outcomes Study Social Support Survey (MOS-SS)
Time Frame: Baseline, up to 2 weeks post intervention, and 3-months post intervention
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.
Baseline, up to 2 weeks post intervention, and 3-months post intervention
Loneliness and Social Isolation -The UCLA 3-Item Loneliness Scale
Time Frame: Baseline, up to 2 weeks post intervention, and 3-months post intervention
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.
Baseline, up to 2 weeks post intervention, and 3-months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Marina Wasilewski, PhD, St. John's Rehab Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 4, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6905

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To maintain patient confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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