A randomized trial of stress management for the prevention of new brain lesions in MS.
OBJECTIVE
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.


METHODS
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.


BACKGROUND
ClinicalTrials.gov, number NCT00147446.
Northwestern University Feinberg School of Medicine, Chicago, IL, USA. d-mohr@northwestern.edu
David C
DC
Mohr
Jesus
J
Lovera
Ted
T
Brown
Bruce
B
Cohen
Thomas
T
Neylan
Roland
R
Henry
Juned
J
Siddique
Ling
L
Jin
David
D
Daikh
Daniel
D
Pelletier
D000328:Adult; D001930:Brain Injuries / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D016009:Chi-Square Distribution; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D005682:Gadolinium; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000534:rehabilitation*; D012189:Retrospective Studies; D016037:Single-Blind Method; D013312:Stress, Physiological / Q000502:physiology*; D013997:Time Factors; D016896:Treatment Outcome
D005682:Gadolinium