Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147446
Status:
COMPLETED
Last Update Posted:
2013-09-10
First Post:
2005-09-02
Brief Title:
Stress Management for Patients With Multiple Sclerosis
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study of the Effects of Stress Management on Neuroimaging Clinical Immune and Psychosocial Outcomes
Status:
COMPLETED
Status Verified Date:
2013-09
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:
There is a growing body of literature showing that stressful life events can increase the risk of developing exacerbations and new brain lesions among people with multiple sclerosis The purpose of this study is to examine the hypothesis that stress management programs can reduce the occurrence of new brain lesions and exacerbations We will also examine potential immune and neuroendocrine pathways
Detailed Description:
MS is a frequently disabling autoimmune disease affecting approximately 350000 people in the United States More than two decades of research has consistently shown a relationship between stressful life events SLEs in particular non-traumatic family and work stressors and subsequent clinical exacerbation Furthermore we have shown that non-traumatic SLEs increase the risk of the subsequent appearance of new gadolinium enhancing Gd magnetic resonance imaging MRI brain lesions an early marker of MS inflammation and blood-brain barrier BBB breakdown The purpose of this study is to determine the efficacy of cognitive behavioral stress management for MS CBSM-MS in reducing the occurrence of new brain lesions in people with relapsing forms of MS Patients must have a documented new Gd MRI brain lesion or clinical exacerbation within the previous 12 months to be enrolled One hundred and twelve patients will be enrolled for 12 months Patients will be randomly assigned to either an intensive CBSM-MS program consisting of 16 individual meetings with a behavioral medicine specialist or a condensed CBSM-MS program consisting of a one-day workshop offered after the 10th month of participation Outcomes include MRI clinical neurological end-points and psychosocial functioning We will also enhance our understanding of mechanisms by examining potential psychosocial immune and endocrine mediators of the relationship between SLEs and clinical and neuroimaging markers of MS inflammation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| R01HD043323 | NIH | None | httpsreporternihgovquickSearchR01HD043323 |