Stress Management for Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Individual Stress Management; Wait List Control
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stress; Stress Management; Behavioral Medicine; Multiple Sclerosis; Psychoneuroimmunology

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.