Stress Management for Patients With Multiple Sclerosis
Phase II Study of the Effects of Stress Management on Neuroimaging, Clinical, Immune and Psychosocial Outcomes
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| No.of Gd+ Lesions From Week 8 to Week 24 | Odds Ratio (OR) 2.77 | 1.17–6.55 | 0.02 |
| No.of Gd+ Lesions From Week 8 to Week 24 | Wilcoxon two smaple test statistics 2.09 | 0.04 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Individual Stress Management
- Wait List Control
Results by group
No.of Gd+ Lesions From Week 8 to Week 24
week 8 to week 24
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Stress Management Therapy for Multiple Sclerosis | 46 participants | 60 | |
| Wait List Control Condition | 33 participants | 61 | |
| Stress Management Therapy for Multiple Sclerosis | 5 participants | 60 | |
| Wait List Control Condition | 13 participants | 61 | |
| Stress Management Therapy for Multiple Sclerosis | 2 participants | 60 | |
| Wait List Control Condition | 6 participants | 61 | |
| Stress Management Therapy for Multiple Sclerosis | 2 participants | 60 | |
| Wait List Control Condition | 6 participants | 61 | |
| Stress Management Therapy for Multiple Sclerosis | 5 participants | 60 | |
| Wait List Control Condition | 3 participants | 61 |
p = 0.04; Wilcoxon two smaple test statistics 2.09
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Stress Management Therapy for Multiple Sclerosis | 60 | 0 (0.0%) | |
| Wait List Control Condition | 61 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
No.of Gd+ Lesions From Week 8 to Week 24
week 8 to week 24
MRI lesions
Other measures (1)
No.of New or Enlarged T2 Lesions From Week 8 to Week 24
week 8 to week 24
MRI lesions
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Confirmed diagnosis of MS * New Gd+ MRI brain lesion or clinically diagnosed exacerbation within the previous 12 months. * Able to speak english. * Age 18 or over. * Able to give informed consent. * Patients taking the drug glatiramer acetate must have been on the drug for at least 6 months prior to their Gd+ MRI brain lesion and/or exacerbation. * Patients taking an interferon beta drug must have been on the drug for at least 1 month prior to their Gd+ MRI brain lesion and/or exacerbation. * Patients not on disease modifying treatment are not planning to initiate treatment.
Exclusion criteria
* Meets criteria for dementia by scoring below the 5th percentile in 3 or more of 6 areas of neuropsychological functioning or as determined by study neuropsychologist. * Severe psychiatric pathology, including schizophrenia, bipolar disorder, current alcoholism or substance abuse, or other severe psychiatric disorder for which this intervention would be inappropriate. * Active and severe suicidal ideation. * Endocrine or metabolic disorder. * Currently in psychotherapy. * Initiated antidepressant therapy within the past 4 weeks. * Received corticosteroid treatment within the past 28 days. * Pregnant or planning pregnancy in the next 12 months. * Has any non-removable metal or medical device in the body for which an MRI could pose a danger. * Has any risk factors for developing nephrogenic systemic fibrosis (NSF) or is allergic to Gadolinium. * Currently uses a Baclofen pump. * Has an Expanded Disability Status Scale score greater than 6.5. * Recently begun relaxation, meditation, yoga, or similar form of disease management course within the past 3 months. * Treatment with Chemotherapy. * Treatment with Tysabri.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
There is a growing body of literature showing that stressful life events can increase the risk of developing exacerbations and new brain lesions among people with multiple sclerosis. The purpose of this study is to examine the hypothesis that stress management programs can reduce the occurrence of new brain lesions and exacerbations. We will also examine potential immune and neuroendocrine pathways.
Papers
Results
Prospective examination of anxiety and depression before and during confirmed and pseudoexacerbations in patients with multiple sclerosis.Psychosom Med · 2013
Results
A randomized trial of stress management for the prevention of new brain lesions in MS.Neurology · 2012
Results
Burns MN, Nawacki E, Kwasny MJ, Pelletier D, Mohr DC. Do positive or negative stressful events predict the development of new brain lesions in people with multiple sclerosis? Psychol Med. 2014 Jan;44(2):349-59. doi: 10.1017/S0033291713000755. Epub 2013 May 17.
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History
Started
May 2005
Main results due
Jan 2009
Finished
Jan 2009
Results posted
Sept 2013