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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Musculoskeletal Injury, Traumatic Injury

Intervention / Treatment
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* Behavioral: Supportive Expressive Group Therapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive-expressive group therapy<br>The SEGT is a six-module program where each session is approximately one hour, and is held twice a week over a three-week period. It is framed within social cognitive theory, whereby resilience to adversity (NMSK trauma in this instance) relies on personal enablement. Enablement serves to equip the individual with the personal resources to cultivate their self-efficacy and mastery and to select and construct environments that promote successful adaption. | Behavioral: Supportive Expressive Group Therapy<br>* The SEGT is a six-module program where each session is approximately one hour, and is held twice a week over a three-week period. It is framed within social cognitive theory, whereby resilience to adversity (NMSK trauma in this instance) relies on personal enablement. Enablement serves to equip the individual with the personal resources to cultivate their self-efficacy and mastery and to select and construct environments that promote successful adaption.<br>|
| No Intervention: Treatment as usual<br>The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant recruitment | Number of participants who are recruited into the study and are contacted for assessments at set time intervals. | Through study completion, an average of 1 year. | 
| Questionnaire completion rates | Number of completed assessments | Through study completion, an average of 1 year. | 
| Treatment adherence | Number of participants who complete all 6 SEGT sessions | Through study completion, an average of 1 year. | 
| Number of participants contacted for follow up interview | Number of participants contacted for follow up interview | At 1 month-post discharge for SEGT group] | 
| Participant retention | Number of participants who complete the 3 month post-discharge assessments | At three months post-discharge for SEGT and control group | 
| Participant Retention | Number of participants who complete 1 month post-discharge interview | At one month post-discharge for SEGT group] | 
| Barriers and Facilitators to Group Participation | As discussed in qualitative interviews | At one month post-discharge for SEGT group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health-related quality of life | Short Form-36 Survey (SF-36): The SF-36 is the most widely used generic health-related QoL tool. The tool measures 8 domains including physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, social functioning, general mental health, role limitations due to emotional problems, and vitality. The minimum score is 0, and the maximum is 100. Higher scores on the measure are indicative of less disability. | 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 | Coping Self-Efficacy Scale (CSES): The CSES is a measures perceived self-efficacy for coping with challenges and threats. It is a 26-item measure rated using an 11-point scale with the anchors 0 (cannot do at), 5 (moderately certain can do), and 10 (certain can do). Total scores (ranging from 0-260) are calculated by summing the item scores and a higher score indicates higher 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 impact of traumatic life event | Impact Event Scale Revised (IES-R): The IES44 is a 15-item scale that assesses the impact of a traumatic life event, and has two subscales assessing the frequency of intrusive and avoidant cognitions associated with a specific stressor. It uses a 4-point scale, not at all to often to assess how often a respondent experienced specific symptoms during the past week. The IES was revised 45 to assess the three cluster symptoms of PTSD: intrusions, avoidance, and hyperarousal. Scores range from 0-88, with higher scores indicating more severe impact. | 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 | Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C): The PCL-C47 is a standardized 17-item self-report rating scale for PTSD. 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, and it is a well-validated measure across different populations. Scores range from a minimum of 0, to a maximum of 80. | 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 | Post-Traumatic Growth Inventory (PTGI): The PTGI is a 21-item scale assessing positive outcomes reported by those who have experienced traumatic events.48 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). | A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group Therapy, Neuromusculoskeletal Traumatic Injury, Feasibility