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Clinical Trials/NCT05320445
NCT05320445
Active, not recruiting
Not Applicable

A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma

Sunnybrook Health Sciences Centre1 site in 1 country55 target enrollmentJanuary 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Musculoskeletal Injury
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
55
Locations
1
Primary Endpoint
Questionnaire completion rates
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

Traumatic physical injuries result in significant disability and a high proportion of survivors suffer from chronic pain and mental health disorders. A key predictor of good outcomes following trauma is "coping self-efficacy" - a person's belief that they can cope with life's challenges. Interventions that enhance coping self-efficacy post-injury are most likely to optimize recovery. However, these interventions are not standard approaches in rehabilitation settings.Our inter-disciplinary team will undertake a trial to assess the efficacy of supportive-expressive group therapy in rehabilitation inpatients who have had traumatic injuries. We wish to test whether persons who undergo the group therapy have significant improvements in coping self-efficacy compared to those receiving standard care. Sixty patients with traumatic injuries admitted to St. John's Rehab will be randomized to either supportive-expressive group therapy (n=30) or to standard rehabilitation (n=30). Additionally, up to 12 staff participants will be recruited.The goal of this project is to establish a gold standard for inpatient rehabilitation in the trauma NMSK injured population by widening the access to emotional wellbeing supports, which could translate into better physical, mental and social health in the community.

Detailed Description

Traumatic neuromusculoskeletal (NMSK) injuries result in significant disability and a high proportion of survivors suffer from chronic pain and mental health disorders. Inpatient acute care and rehabilitation are important treatments for patients after NMSK injury, however much of the work to ensure successful community participation occurs after discharge. A key mechanism for predicting outcomes following trauma is coping self-efficacy, therefore interventions that enhance coping self-efficacy post-NMSK injury are most likely to optimize recovery. However, these interventions are not standard approaches in rehabilitation settings. Our inter-disciplinary team will undertake a feasibility randomized control trial (RCT) to assess the efficacy of supportive-expressive group therapy (SEGT) in NMSK injury rehabilitation inpatients. It is hypothesized that persons who undergo the SEGT will yield significant improvements in coping self-efficacy compared to those receiving standard care. A prospective feasibility RCT design will be used to evaluate SEGT for NMSK injury rehabilitation inpatients compared to the standard rehabilitation for trauma patients at St John's Rehab (SJR). Sixty patients with an NMSK injury admitted to SJR will be randomized to either SEGT (n=30) or to standard rehabilitation (n=30). Additionally, up to 12 staff participants will be recruited to complete qualitative interviews/focus groups. A repeated measures ANOVA will be used to detect differences on the outcome measures, which will include a group, time, and groups by time interaction term. Linear regression will be used to adjust for potential covariates of interest. A thematic content analysis will be used to analyze the qualitative data. The long-term outcomes of this project is to establish a gold standard for inpatient rehabilitation in the trauma NMSK injured population by widening the access to emotional wellbeing supports, which could translate into better physical, mental and social health in the community.

Registry
clinicaltrials.gov
Start Date
January 23, 2023
End Date
March 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • English speaking adults aged 18 years and older.
  • Admitted to SJR for inpatient rehabilitation.
  • Trauma-related peripheral nerve injury, muscle injury, amputation, and/or fracture(s).
  • Are medically stable.
  • Have no clinical suspicion of cognitive impairment or unstable severe mental health diagnosis (e.g. moderate/severe brain injury, schizophrenia, dementia, etc.).

Exclusion Criteria

  • Are actively suicidal.
  • Are unable participate effectively in a group setting (e.g. actively using substances, exhibiting threatening behaviors).

Outcomes

Primary Outcomes

Questionnaire completion rates

Time Frame: Through study completion, an average of 1 year.

Number of completed assessments

Treatment adherence

Time Frame: Through study completion, an average of 1 year.

Number of participants who complete all 6 SEGT sessions

Participant recruitment

Time Frame: Through study completion, an average of 1 year.

Number of participants who are recruited into the study and are contacted for assessments at set time intervals.

Number of participants contacted for follow up interview

Time Frame: At 1 month-post discharge for SEGT group]

Number of participants contacted for follow up interview

Participant retention

Time Frame: At three months post-discharge for SEGT and control group

Number of participants who complete the 3 month post-discharge assessments

Barriers and Facilitators to Group Participation

Time Frame: At one month post-discharge for SEGT group

As discussed in qualitative interviews

Participant Retention

Time Frame: At one month post-discharge for SEGT group]

Number of participants who complete 1 month post-discharge interview

Secondary Outcomes

  • Change in impact of traumatic life event(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)
  • Change in coping self-efficacy(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)
  • Change in Health-related quality of life(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)
  • Change in post-traumatic stress disorder(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)
  • Change in post-traumatic growth(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)

Study Sites (1)

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