Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05320445
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2022-04-01
Brief Title:
A Psychosocial Transitional Group to Improve Adaptation Coping and Mental Health Outcomes Following Trauma
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
A Psychosocial Transitional Group to Improve Adaptation Coping and Mental Health Outcomes Following Trauma
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons belief that they can cope with lifes challenges Interventions that enhance coping self-efficacy post-injury are most likely to optimize recovery However these interventions are not standard approaches in rehabilitation settingsOur 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 Johns Rehab will be randomized to either supportive-expressive group therapy n30 or to standard rehabilitation n30 Additionally up to 12 staff participants will be recruitedThe 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 Johns Rehab SJR Sixty patients with an NMSK injury admitted to SJR will be randomized to either SEGT n30 or to standard rehabilitation n30 Additionally up to 12 staff participants will be recruited to complete qualitative interviewsfocus 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
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 Johns Rehab SJR Sixty patients with an NMSK injury admitted to SJR will be randomized to either SEGT n30 or to standard rehabilitation n30 Additionally up to 12 staff participants will be recruited to complete qualitative interviewsfocus 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None