Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428006
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-13
Brief Title:
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-08
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:
CALM
Brief Summary:
The incidence of insomnia is estimated to be as high as 90 in individuals with MS due to insomnia being underdiagnosed Sleep disturbances in people with MS have been associated with reduced cognitive performance physical function psychological well-being quality of life and occupational function as well as increased prevalence of fatigue pain depression and anxiety The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia CBT-I to improve insomnia symptoms Aim 1 fatigue and health-related quality of life Aim 2 in individuals with multiple sclerosis compared to an active control group and to determine the characteristics of participants that predict improvement in sleep outcomes Exploratory Aim 3
Detailed Description:
None
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