Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05082870
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2021-09-16
Brief Title:
Using a Psychosocial Transitional Group to Improve Adaptation Coping and Mental Health Outcomes Following Limb Loss
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Using a Psychosocial Transitional Group to Improve Adaptation Coping and Mental Health Outcomes Following Limb Loss
Status:
COMPLETED
Status Verified Date:
2023-07
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:
People with limb loss receiving inpatient rehabilitation are at greater risk for depression and anxiety social isolation and generally have poor quality of life To proactively address the mental health needs of this population this study plans to test an innovative psychological group therapy program designed for limb loss inpatients to enhance coping skills address mental health challenges and better prepare them to integrate back into the community via a randomized blinded feasibility trial Since this is a novel intervention adapted specifically for limb loss this study will test the feasibility of delivering this inpatient group program to these at-risk individuals to see if they will participate in the program what they likedo not like about it and if there are some early findings suggesting it is effective Researchers will use these results to improve the psychosocial group program and to further test its effectiveness in a larger clinical study
Detailed Description:
Lower limb extremity amputation LEA is a debilitating event that negatively affects many aspects of an individuals life such as their mobility physical and mental health and ultimately quality of life QoL Due to the high rates of diabetes in Canada the most common type of limb loss is dysvascular due to complications of diabetesvascular disease
Compared to other limb loss populations trauma or tumor people with dysvascular LEA have been shown to have poorer QoL Premorbid comorbidities eg coronary heart disease etc and post-morbid complications such as depression anxiety and chronic pain further impact wellbeing Sequelae of these issues include impaired body image and high rates of suicidal ideation Rates of depression have been found to be as high as 60 comorbid depression is associated with lower prosthetic use higher perceived vulnerability and lower self-rated overall health Providers however often focus efforts on the patients physical recovery post-LEA and may not adequately address psychosocial functioning
There is some preliminary evidence on the efficacy of group therapy approaches for limb loss patients undergoing inpatient rehabilitation in India and outpatient rehabilitation in Canada but findings are limited and may not be fully generalizable to dysvascular LEA
Hence the planned innovative intervention will provide clarification on the feasibility of undertaking a larger scale trial to assess the efficacy of an inpatient group therapy approach to address the mental health concerns ie depression and anxiety and psychosocial needs ie coping skills of limb loss patients Based on available knowledge this would be the first of its kind in Canada
Compared to other limb loss populations trauma or tumor people with dysvascular LEA have been shown to have poorer QoL Premorbid comorbidities eg coronary heart disease etc and post-morbid complications such as depression anxiety and chronic pain further impact wellbeing Sequelae of these issues include impaired body image and high rates of suicidal ideation Rates of depression have been found to be as high as 60 comorbid depression is associated with lower prosthetic use higher perceived vulnerability and lower self-rated overall health Providers however often focus efforts on the patients physical recovery post-LEA and may not adequately address psychosocial functioning
There is some preliminary evidence on the efficacy of group therapy approaches for limb loss patients undergoing inpatient rehabilitation in India and outpatient rehabilitation in Canada but findings are limited and may not be fully generalizable to dysvascular LEA
Hence the planned innovative intervention will provide clarification on the feasibility of undertaking a larger scale trial to assess the efficacy of an inpatient group therapy approach to address the mental health concerns ie depression and anxiety and psychosocial needs ie coping skills of limb loss patients Based on available knowledge this would be the first of its kind in Canada
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