Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04300816
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2020-03-04
Brief Title:
Coping and Adjusting to Living With Multiple Sclerosis
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Efficacy of a Psychosocial Intervention to Improve Ability to Cope With Uncertainty in MS
Status:
COMPLETED
Status Verified Date:
2023-06
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:
CALMS
Brief Summary:
The purpose of this project is to test a brief telephone-based psychological intervention CBT-UT to improve the ability to tolerate uncertainty-and thereby to reduce distress-in people with a recent diagnosis of Multiple Sclerosis MS There are three treatment arms for this study Participants will receive either 1 CBT for Uncertainty Tolerance 2 Traditional CBT or 3 treatment as usual
Detailed Description:
Despite substantial improvements in diagnosis and treatment Multiple Sclerosis MS remains an unpredictable disease Although some physicians can make some predictions about expected progression the variable course of exacerbations makes it almost impossible to predict how MS will develop or affect function over time As a result people with MS must learn to live in a state of chronic uncertainty and the ability to tolerate and cope with this kind of uncertainty is central to quality of life with MS Individuals who require certainty about the future and are not able to tolerate ambiguity are said to be high in a personality trait known as intolerance of uncertainty IU There is a significant gap in MS clinical intervention that necessitates attention An intervention that specifically targets IU is developed for people recently diagnosed with MS and can be provided remotely via telehealth can make a significant impact for this population Study aims include 1 to determine the efficacy of CBT-UT relative to traditional cognitive behavioral therapy tCBT or treatment as usual TAU in people diagnosed with MS in the past 3 years and 2 To increase our understanding of the mechanisms underlying the intervention effects
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