Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05195320
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2021-11-15
Brief Title:
Reinventing Yourself With Multiple Sclerosis MS
Sponsor:
Kessler Foundation
Organization:
Kessler Foundation
Study Overview
Official Title:
Reinventing Yourself With Multiple Sclerosis MS An Intervention Aimed at Improving Self-Efficacy Coping Psychological Well-being and Quality of Life in MS
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
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:
Given the knowledge that detriments in QOL well-being and participation are common in MS and attributable in a large part to individual person-specific factors eg self-efficacy efforts to develop interventions aimed at addressing these factors is well needed and likely to have a significant impact The proposed investigation will consist of two phases involving participant recruitment and data collection Phase 1 will consist of a focus group aimed at identifying the unique needs of individuals with MS and findings will be used to adapt the Reinventing Yourself after Spinal Cord Injury SCI intervention to Reinventing Yourself with MS Phase 2 will consist of a randomized controlled trial RCT in which the feasibility and efficacy of the intervention in a new population can be examined
Detailed Description:
Multiple sclerosis MS is the leading cause of disability among middle-aged adults with recent estimates of nearly 1 million adults living with MS in the United States Multiple sclerosis affects women anywhere from two to three times as often as men with an age of diagnosis ranging from 20 to 50 years of age and a mean age of onset of 33 years of age A host of physical cognitive and behavioral changes are common following the onset of this most common non-traumatic neurological disorder of middle adulthood which greatly impacts quality of life QOL well-being and everyday functioning and participation Moreover given that individuals are typically diagnosed with MS in the prime of their lives many are making important life decisions regarding work family etc that are often hindered by their diagnosis In fact it has been found that men and women with MS aged 25-44 an age at which important early life decisions are often made experienced more depression than their age-matched healthy counterparts Again the course of the disease is variable and unpredictable with no known cure which can lead to great uncertainty and difficulty in adjusting to a chronic and often debilitating disease
The overarching aim of the proposed investigation is to adapt the Reinventing Yourself intervention for use with MS and examine the feasibility and efficacy in increasing MS-specific and general self-efficacy and resilience enhancing psychological well-being fostering new ways of perceiving and managing ones illness in more proactive and positive ways and improving participation in the community To achieve this the investigation has the following specific aims
Specific Aim 1 Conduct a focus group with individuals with MS to identify unique needs of individuals with MS with regard to MS symptoms barriers to well-being QOL and participation and the role that person-specific factors eg self-efficacy resilience and other psychological and social factors have contributed to success or failure in managing ones illness and living well
Specific Aim 2 With the knowledge gained from Aim 1 modify the Reinventing Yourself intervention with the specific needs of MS while maintaining the integrity and common principles of the Reinventing Yourself intervention
Specific Aim 3 Conduct a RCT among individuals with MS to determine the feasibility and efficacy of the Reinventing Yourself with MS intervention
The overarching aim of the proposed investigation is to adapt the Reinventing Yourself intervention for use with MS and examine the feasibility and efficacy in increasing MS-specific and general self-efficacy and resilience enhancing psychological well-being fostering new ways of perceiving and managing ones illness in more proactive and positive ways and improving participation in the community To achieve this the investigation has the following specific aims
Specific Aim 1 Conduct a focus group with individuals with MS to identify unique needs of individuals with MS with regard to MS symptoms barriers to well-being QOL and participation and the role that person-specific factors eg self-efficacy resilience and other psychological and social factors have contributed to success or failure in managing ones illness and living well
Specific Aim 2 With the knowledge gained from Aim 1 modify the Reinventing Yourself intervention with the specific needs of MS while maintaining the integrity and common principles of the Reinventing Yourself intervention
Specific Aim 3 Conduct a RCT among individuals with MS to determine the feasibility and efficacy of the Reinventing Yourself with MS intervention
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