At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of multiple sclerosis
- ✓New gadolinium-enhancing MRI brain lesion or clinically diagnosed exacerbation within the past 12 months
- ✓Age 18 or older
- ✓Able to speak English
- ✕Dementia (scoring below 5th percentile in 3 or more of 6 neuropsychological domains)
- ✕Severe psychiatric pathology including schizophrenia, bipolar disorder, current alcoholism/substance abuse, or other severe psychiatric disorder
- ✕Active and severe suicidal ideation
- ✕Endocrine or metabolic disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of the Effects of Stress Management on Neuroimaging, Clinical, Immune and Psychosocial Outcomes
In Brief
A Phase 2 clinical trial evaluating Individual Stress Management and Wait List Control for Multiple Sclerosis. Completed, enrolled 121 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Stress management therapy for multiple sclerosis (SMT-MS) is a manualized, validated, published stress management program designed for patients with MS. Participants met with a therapist for 16 individual 50-minute sessions conducted over 20-24 weeks. The first 6 sessions focused on teaching problem solving skills, relaxation, increasing positive activities, cognitive restructuring, and enhancement of social support. Participants were able to tailor the treatment to meet their needs using optional treatment modules including communication and assertiveness training, fatigue management, anxiety reduction, pain management, management of cognitive problems, insomnia treatment, and management of sexual dysfunction.
Wait List Control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluation that were not contaminated by the workshop.