Stress Management for Patients with Multiple Sclerosis - Article
Clinical Trial: Stress Management for Patients with Multiple Sclerosis
This study is currently recruiting patients.
Verified by National Institute of Child Health and Human Development (NICHD) September 2005
|Multiple Sclerosis || Behavior: Cognitive Behavioral Stress Management for MS ||Phase II |
MedlinePlus related topics: Multiple Sclerosis
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Phase II Study of the Effects of Stress Management on Neuroimaging, Clinical, Immune and Psychosocial Outcomes
Secondary Outcomes: Quality of Life at baseline, month 4, month 8 and month 12
Expected Total Enrollment: 120
Study start: May 2005
- 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
- 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.
Location and Contact Information
Claudine Catledge, MA 415-221-4810 Ext. 4954 email@example.com
UCSF Behavioral Medicine Research Center, San Francisco, California, 94121, United States; Recruiting
David C Mohr, Ph.D., Principal Investigator
MS Hub, Seattle, Washington, United States; Recruiting
Ted Brown, MD, Principal Investigator
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
Website for the UCSF Behavioral Medicine Research Center
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