Improving Psoriasis Through Health and Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin.
研究概览
简要总结
The purpose of the study is to examine and compare the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) program on adults with psoriasis in terms of how these programs may affect their psoriasis, immune function, physical and emotional health, and well-being.
详细描述
The study examines the effects of two eight-week programs (MBSR vs. LW) for disease processes in patients with psoriasis severity reporting moderate or higher perceived stress. The research will focus both on clinical measures of the disease state and overall well-being.
The Aims of our proposed intervention study are the following:
- To examine the effects of MBSR, versus the Living Well (LW) program, on (a) disease severity, immunological markers of inflammation, and keratinocyte proliferation, (b) psoriasis-related stress and perceived stress in general, and (c) anxiety and depression.
- To examine whether treatment effects of either program are moderated by personality traits, mindfulness, and age.
- To examine the effects of behavioral and psychological mediators on immune outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 and older
- •English speaking
- •Clinical diagnosis of psoriasis (active at initial visit)
排除标准
- •currently receiving immunosuppressive therapy for cancer or for diseases unrelated to psoriasis (or < 6 months post-chemo or radiation)
- •major, uncorrected sensory impairments
- •cognitive deficits (MMSE <25, or deficits deemed significant enough to interfere)
- •severe cardiovascular disease
- •current alcohol abuse or non-alcohol psychoactive substance use disorders, psychotic disorders (current and lifetime), and current mood disorder with psychotic features.
结局指标
主要结局
Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin.
时间窗: 8 weeks
Psoriasis is assessed for keratinocyte proliferation including immunohistochemistry (for CD3, neutrophil elastase, keratin 6 and S100A7 markers) and quantitative real time polymerase chain reaction (qRT-PCR) to examine expression of mRNA for IFN-γ, TNF-α, IL-17A, and the shared p40 subunit of IL-12 and IL-23 (assessed pre \& post intervention).
次要结局
- Immunological markers of inflammation measured from blood samples.(16 weeks)
- Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983))(16 weeks)
- State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970))(16 weeks)
研究者
Jan Moynihan
Director, The Rochester Center for Mind-Body Research
University of Rochester