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.

Condition	Intervention	Phase
Multiple Sclerosis	Behavior: Cognitive Behavioral Stress Management for MS	Phase II

Further Study Details: 

Primary Outcomes: MRI - acquired at baseline, and months 2, 4, 6, 8, 10, 12; Exacerbation rate based on patient report and verification by neurologist.; EDSS & MSFC at baseline, month 4, month 8 and month 12
Secondary Outcomes: Quality of Life at baseline, month 4, month 8 and month 12
Expected Total Enrollment:  120

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 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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 the and interferon beta drug must have been on the drug for at least 1 month prior to their Gd+ MRI brain lesion and/or exacerbation

Exclusion Criteria:

• 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 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00147446

Shiela Rosenthal, BA      800-923-1033    bmrc@itsa.ucsf.edu
Claudine Catledge, MA      415-221-4810  Ext. 4954    claudine.catledge@med.va.gov

California
      UCSF Behavioral Medicine Research Center, San Francisco,  California,  94121,  United States; Recruiting
Washington
      MS Hub, Seattle,  Washington,  United States; Recruiting

Study chairs or principal investigators

David C. Mohr, Ph.D.,  Principal Investigator,  University of California, San Francisco   
Claudine Catledge, MA,  Study Director,  San Francisco VAMC & Northern California Institute of Research and Education   

Study ID Numbers:  SIMS; R01 HD043323
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00147446
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13