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Abstract
Objectives: This trial examined the efficacy of a stress management program in reducing neuroimaging markers of multiple sclerosis (MS) disease activity.
Methods: A total of 121 patients with relapsing forms of MS were randomized to receive stress management therapy for MS (SMT-MS) or a wait-list control condition. SMT-MS provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up. The primary outcome was the cumulative number of new gadolinium-enhancing (Gd+) brain lesions on MRI at weeks 8, 16, and 24. Secondary outcomes included new or enlarging T2 MRI lesions, brain volume change, clinical exacerbation, and stress.
Results: SMT-MS resulted in a reduction in cumulative Gd+ lesions (p = 0.04) and greater numbers of participants remained free of Gd+ lesions during the treatment (76.8% vs 54.7%, p = 0.02), compared to participants receiving the control treatment. SMT-MS also resulted in significantly reduced numbers of cumulative new T2 lesions (p = 0.005) and a greater number of participants remaining free of new T2 lesions (69.5% vs 42.7%, p = 0.006). These effects were no longer detectable during the 24-week post-treatment follow-up period.
Conclusions: This trial indicates that SMT-MS may be useful in reducing the development of new MRI brain lesions while patients are in treatment.
Classification of evidence: This study provides Class I evidence that SMT-MS, a manualized stress management therapy program, reduced the number of Gd+ lesions in patients with MS during a 24-week treatment period. This benefit was not sustained beyond 24 weeks, and there were no clinical benefits.
Trial registration: ClinicalTrials.gov, number NCT00147446.
GLOSSARY
- BIPS=
- Brief Inventory of Perceived Stress;
- DMT=
- disease-modifying therapy;
- EDSS=
- Expanded Disability Status Scale;
- Gd+=
- gadolinium-enhancing;
- ITT=
- intent-to-treat;
- LES=
- Life Events Scale;
- MS=
- multiple sclerosis;
- NNT=
- number needed to treat;
- RCT=
- randomized controlled clinical trial;
- SMT-MS=
- stress management therapy for multiple sclerosis;
- UCSF=
- University of California San Francisco.
Footnotes
Study funding: This study was funded by NICHD grant R01-HD043323.
Editorial, page 398
- Received August 11, 2011.
- Accepted January 17, 2012.
- Copyright © 2012 by AAN Enterprises, Inc.
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