Phase II Study of the Effects of Stress Management on Neuroimaging, Clinical, Immune and Psychosocial Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 6
- 主要终点
- No.of Gd+ Lesions From Week 8 to Week 24
研究概览
简要总结
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.
详细描述
MS is a frequently disabling autoimmune disease affecting approximately 350,000 people in the United States. More than two decades of research has consistently shown a relationship between stressful life events (SLEs), in particular non-traumatic family and work stressors, and subsequent clinical exacerbation. Furthermore, we have shown that non-traumatic SLEs increase the risk of the subsequent appearance of new gadolinium enhancing (Gd+) magnetic resonance imaging (MRI) brain lesions, an early marker of MS inflammation and blood-brain barrier (BBB) breakdown. The purpose of this study is to determine the efficacy of cognitive behavioral stress management for MS (CBSM-MS) in reducing the occurrence of new brain lesions in people with relapsing forms of MS. Patients must have a documented new Gd+ MRI brain lesion or clinical exacerbation within the previous 12 months to be enrolled. One hundred and twelve patients will be enrolled for 12 months. Patients will be randomly assigned to either an intensive CBSM-MS program, consisting of 16 individual meetings with a behavioral medicine specialist, or a condensed CBSM-MS program, consisting of a one-day workshop offered after the 10th month of participation. Outcomes include MRI, clinical neurological end-points, and psychosocial functioning. We will also enhance our understanding of mechanisms by examining potential psychosocial, immune, and endocrine mediators of the relationship between SLEs and clinical and neuroimaging markers of MS inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Recently begun relaxation, meditation, yoga, or similar form of disease management course within the past 3 months.
- •Treatment with Chemotherapy.
- •Treatment with Tysabri.
结局指标
主要结局
No.of Gd+ Lesions From Week 8 to Week 24
时间窗: week 8 to week 24
Gd+ is Gadolinium-enhancing MRI brain lesion, A marker of the opening of the blood-brain barrier and is typically used as a primary endpoints in phase II trials because of its high sensitivity to ongoing MS disease activity and its association with clinical exacerbation. The single value was calculated by summing up the lesions from week 8 to week 24.
次要结局
- No.of New or Enlarged T2 Lesions From Week 8 to Week 24(week 8 to week 24)
研究者
David Mohr
Professor
Northwestern University