Status:
COMPLETED
Stress Management for Patients With Multiple Sclerosis
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 th...
Detailed Description
MS is a frequently disabling autoimmune disease affecting approximately 350,000 people in the United States. More than two decades of research has consistently shown a relationship between stressful l...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of MS
- New Gd+ MRI brain lesion or clinically diagnosed exacerbation within the previous 12 months.
- Able to speak english.
- Age 18 or over.
- Able to give informed consent.
- Patients taking the drug glatiramer acetate must have been on the drug for at least 6 months prior to their Gd+ MRI brain lesion and/or exacerbation.
- Patients taking an interferon beta drug must have been on the drug for at least 1 month prior to their Gd+ MRI brain lesion and/or exacerbation.
- Patients not on disease modifying treatment are not planning to initiate treatment.
Exclusion
- Meets criteria for dementia by scoring below the 5th percentile in 3 or more of 6 areas of neuropsychological functioning or as determined by study neuropsychologist.
- Severe psychiatric pathology, including schizophrenia, bipolar disorder, current alcoholism or substance abuse, or other severe psychiatric disorder for which this intervention would be inappropriate.
- Active and severe suicidal ideation.
- Endocrine or metabolic disorder.
- Currently in psychotherapy.
- Initiated antidepressant therapy within the past 4 weeks.
- Received corticosteroid treatment within the past 28 days.
- Pregnant or planning pregnancy in the next 12 months.
- Has any non-removable metal or medical device in the body for which an MRI could pose a danger.
- Has any risk factors for developing nephrogenic systemic fibrosis (NSF) or is allergic to Gadolinium.
- Currently uses a Baclofen pump.
- Has an Expanded Disability Status Scale score greater than 6.5.
- Recently begun relaxation, meditation, yoga, or similar form of disease management course within the past 3 months.
- Treatment with Chemotherapy.
- Treatment with Tysabri.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00147446
Start Date
May 1 2005
End Date
January 1 2009
Last Update
September 10 2013
Active Locations (3)
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1
UCSF Behavioral Medicine Research Center
San Francisco, California, United States, 94121
2
Northwestern University, Department of Preventive Medicine
Chicago, Illinois, United States, 60611
3
MS Center at Evergreen Medical Center
Kirkland, Washington, United States, 98034