PT  - JOURNAL ARTICLE
AU  - David C. Mohr
AU  - Jesus Lovera
AU  - Ted Brown
AU  - Bruce Cohen
AU  - Thomas Neylan
AU  - Roland Henry
AU  - Juned Siddique
AU  - Ling Jin
AU  - David Daikh
AU  - Daniel Pelletier
TI  - A randomized trial of stress management for the prevention of new brain lesions in MS
AID  - 10.1212/WNL.0b013e3182616ff9
DP  - 2012 Jul 31
TA  - Neurology
PG  - 412--419
VI  - 79
IP  - 5
4099  - http://n.neurology.org/content/79/5/412.short
4100  - http://n.neurology.org/content/79/5/412.full
SO  - Neurology2012 Jul 31; 79
AB  - 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. 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.