Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04306952
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2020-02-28
Brief Title:
Awareness and Self-Compassion Enhancing Narcolepsy Treatment
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Mind-Body Approach to Improve Health-Related Quality of Life for People With Narcolepsy
Status:
COMPLETED
Status Verified Date:
2024-07
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:
ASCENT
Brief Summary:
The overall goal of this research is to test the effectiveness of a mindfulness-based intervention MBI for improving health-related quality of life as a complementary practice to standard care for narcolepsy This study is a feasibility trial in which 60 adults with narcolepsy will be randomized to receive either a 4-week brief 8-week standard or 12-week extended MBI Each MBI will be delivered in small groups using a live videoconferencing platform and teaches mindfulness practices to help cope with narcolepsy symptoms By developing a scalable mind-body intervention this project can addresses a major research gap on improving psychosocial functioning in people with narcolepsy
Detailed Description:
Narcolepsy is a serious and debilitating condition involving persistent and excessive sleepiness that affects 1 in 2000 Americans and 3 million people worldwide Although wake-promoting pharmacotherapy can reduce sleepiness there is no cure and people with narcolepsy experience significantly poor health-related quality of life particularly in the domains of mental and social health Therefore the overarching goal of this research is to test the effectiveness of a mindfulness-based intervention MBI for improving health-related quality of life as a complementary practice to standard care for narcolepsy The purpose of this study is to conduct a feasibility trial to determine the optimal parameters for adapting and delivering MBI to people with narcolepsy The specific aims are to 1 Determine the feasibility and acceptability of MBI delivered using videoconferencing for the purpose of improving psychosocial functioning in people with narcolepsy and 2 Determine the feasibility of recruitment and assessment methods for delivering MBI using videoconferencing The feasibility trial includes 60 adults with narcolepsy who will be randomized to receive either a 4-week brief 8-week standard or 12-week extended MBI Each MBI will be similar in content which includes mindfulness practices and group discussions with adaptations for working with narcolepsy symptoms All MBIs will be delivered in small groups using a live videoconferencing platform to enhance accessibility If the findings of this project support the feasibility of further testing the next project would be aimed at enhancing rigor and reproducibility eg designing appropriate control refining outcome measures and eligibility criteria in preparation for a large-scale pragmatic trial The overall significance of this research is to develop a scalable mind-body intervention that addresses a major research gap on improving psychosocial functioning in people with narcolepsy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34AT009551 | NIH | None | httpsreporternihgovquickSearchR34AT009551 |