Phase 2
N=121
Stress Management for Patients With Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00147446 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: No.of Gd+ Lesions From Week 8 to Week 24 — 46; 33; 5; 13 participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Individual Stress Management (Behavioral); Wait List Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY No.of Gd+ Lesions From Week 8 to Week 24 |
46; 33; 5; 13; 2; 6 | 0.04 sig |
| SECONDARY No.of New or Enlarged T2 Lesions From Week 8 to Week 24 |
43; 26; 8; 9; 1; 9 | 0.005 sig |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00147446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.