Stress Management for Patients With Multiple Sclerosis

Completed · Phase 2

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00147446

Run by

Northwestern University

People needed

121

Starts

2005-05-01

Expected to finish

2009-01-01

Last updated by the study team

2013-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSF Behavioral Medicine Research Center — San Francisco, California, United States
• Northwestern University, Department of Preventive Medicine — Chicago, Illinois, United States
• MS Center at Evergreen Medical Center — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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