RT Journal Article
SR Electronic
T1 A randomized trial of stress management for the prevention of new brain lesions in MS
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP 412
OP 419
DO 10.1212/WNL.0b013e3182616ff9
VO 79
IS 5
A1 David C. Mohr
A1 Jesus Lovera
A1 Ted Brown
A1 Bruce Cohen
A1 Thomas Neylan
A1 Roland Henry
A1 Juned Siddique
A1 Ling Jin
A1 David Daikh
A1 Daniel Pelletier
YR 2012
UL http://n.neurology.org/content/79/5/412.abstract
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.