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

Not Applicable

Active, not recruiting

• Conditions: Traumatic Injury; Musculoskeletal Injury
• Interventions: Behavioral: Supportive Expressive Group Therapy

• Registration Number: NCT05320445
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-11
• Study Start: 2023-01-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive-expressive group therapy	Supportive Expressive Group Therapy	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.

Primary Outcome Measures

Name	Time	Method
Questionnaire completion rates	Through study completion, an average of 1 year.	Number of completed assessments
Treatment adherence	Through study completion, an average of 1 year.	Number of participants who complete all 6 SEGT sessions
Participant recruitment	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	At 1 month-post discharge for SEGT group]	Number of participants contacted for follow up interview
Participant retention	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	At one month post-discharge for SEGT group	As discussed in qualitative interviews
Participant Retention	At one month post-discharge for SEGT group]	Number of participants who complete 1 month post-discharge interview

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.
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	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.
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	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).

Trial Locations

Locations (1)

Sunnybrook Research Institute; 🇨🇦 Toronto, Ontario, Canada