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

Neurology. 2012 Jul 31;79(5):412-9. doi: 10.1212/WNL.0b013e3182616ff9. Epub 2012 Jul 11.


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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Brain Injuries / diagnosis
  • Brain Injuries / etiology
  • Brain Injuries / prevention & control*
  • Chi-Square Distribution
  • Cognitive Behavioral Therapy / methods*
  • Disability Evaluation
  • Female
  • Follow-Up Studies
  • Gadolinium
  • Humans
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Multiple Sclerosis / complications
  • Multiple Sclerosis / rehabilitation*
  • Retrospective Studies
  • Single-Blind Method
  • Stress, Physiological / physiology*
  • Time Factors
  • Treatment Outcome


  • Gadolinium

Associated data

  • ClinicalTrials.gov/NCT00147446