Response of Urticaria to Stress Intervention
2018年2月16日 更新者：University of Mississippi Medical Center
Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation
Several studies have shown a relationship between psychological stress and chronic urticaria (hives).
The primary objective of this study is to evaluate the effect psychological stress intervention has on chronic urticaria.
研究概览
详细说明
As many patients with chronic urticaria display heightened levels of stress before and/or after the onset of the urticaria, the purpose of this study is to evaluate the effect of psychological stress intervention on chronic urticaria.
Intervention group participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques.
Control group participants will meet with a psychiatry resident once a week for six consecutive weeks for general supportive therapy, which will not provide psychological stress intervention.
All participants will complete a packet of psychological and dermatological questionnaires before the first session with the psychiatry resident and one week after the final session.
All participants will record daily 1) their urticaria symptoms and 2) the type and number of antihistamines taken.
Blood and saliva samples will be collected before the first session and one week after completion of the final session to compare the levels of stress hormones and cytokines in order to evaluate an effect on immune dysregulation.
研究类型
介入性
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Mississippi
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Jackson、Mississippi、美国、39216
- University of Mississippi Medical Center
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Jackson、Mississippi、美国、39216
- University of Mississippi
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 64年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males and females age 18-64 years who are inadequately controlled on H1 and/or H2-blocker therapy for chronic urticaria
- The Urticaria Activity Score must have a score of at least 2 (one point from each of the two categories: number of hives and severity of pruritus).
Exclusion Criteria:
- Urticaria secondary to vasculitis
- Use of prednisone, hydroxychloroquine, cyclosporine, or a tricyclic antidepressant (except Doxepin) within the 30 days prior to enrollment
- A history of anaphylaxis
- Non-controlled or debilitating chronic diseases (poorly controlled diabetes or congestive heart failure)
- An immune system disorder
- Deranged stress hormone level (for example, Cushing's disease)
- Ongoing omalizumab therapy
- Nocturnal employment (which would effect study measures, such as cortisol levels).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Control
Participants will meet with a psychiatry resident once a week for six consecutive weeks for general supportive therapy, which will not provide psychological stress intervention.
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There is no focus on stress intervention.
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实验性的：Intervention
Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques.
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Intervention group participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques focusing on relaxation, mindfulness, emotion regulation and acceptance and willingness.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
大体时间：6 weeks
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6 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.
大体时间：6 weeks
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6 weeks
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Evaluate pre- and post-intervention cytokine and stress hormone levels.
大体时间：6 weeks
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6 weeks
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The number of as-needed antihistamines used as the study progresses.
大体时间：6 weeks
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6 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：John W Tole, D.O.、University of Mississippi Medical Center Div of Allergy and Immunology
- 研究主任：Gailen D Marshall, M.D.、University of Mississippi Medical Center Div of Allergy and Immunology
- 研究主任：Kim L Gratz, Ph.D.、University of Mississippi Medical Center Div of Psychiatry
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
- Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
- Powell RJ, Du Toit GL, Siddique N, Leech SC, Dixon TA, Clark AT, Mirakian R, Walker SM, Huber PA, Nasser SM; British Society for Allergy and Clinical Immunology (BSACI). BSACI guidelines for the management of chronic urticaria and angio-oedema. Clin Exp Allergy. 2007 May;37(5):631-50. doi: 10.1111/j.1365-2222.2007.02678.x.
- Sperber J, Shaw J, Bruce S. Psychological components and the role of adjunct interventions in chronic idiopathic urticaria. Psychother Psychosom. 1989;51(3):135-41. doi: 10.1159/000288147.
- Papadopoulou N, Kalogeromitros D, Staurianeas NG, Tiblalexi D, Theoharides TC. Corticotropin-releasing hormone receptor-1 and histidine decarboxylase expression in chronic urticaria. J Invest Dermatol. 2005 Nov;125(5):952-5. doi: 10.1111/j.0022-202X.2005.23913.x.
- Yang HY, Sun CC, Wu YC, Wang JD. Stress, insomnia, and chronic idiopathic urticaria--a case-control study. J Formos Med Assoc. 2005 Apr;104(4):254-63.
- Ozkan M, Oflaz SB, Kocaman N, Ozseker F, Gelincik A, Buyukozturk S, Ozkan S, Colakoglu B. Psychiatric morbidity and quality of life in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2007 Jul;99(1):29-33. doi: 10.1016/S1081-1206(10)60617-5.
- Silvares MR, Coelho KI, Dalben I, Lastoria JC, Abbade LP. Sociodemographic and clinical characteristics, causal factors and evolution of a group of patients with chronic urticaria-angioedema. Sao Paulo Med J. 2007 Sep 6;125(5):281-5. doi: 10.1590/s1516-31802007000500006.
- Berrino AM, Voltolini S, Fiaschi D, Pellegrini S, Bignardi D, Minale P, Troise C, Maura E. Chronic urticaria: importance of a medical-psychological approach. Eur Ann Allergy Clin Immunol. 2006 May;38(5):149-52.
- Annesi-Maesano I, Beyer A, Marmouz F, Mathelier-Fusade P, Vervloet D, Bauchau V. Do patients with skin allergies have higher levels of anxiety than patients with allergic respiratory diseases? Results of a large-scale cross-sectional study in a French population. Br J Dermatol. 2006 Jun;154(6):1128-36. doi: 10.1111/j.1365-2133.2006.07186.x.
- Marshall GD. Neuroendocrine mechanisms of immune dysregulation: applications to allergy and asthma. Ann Allergy Asthma Immunol. 2004 Aug;93(2 Suppl 1):S11-7. doi: 10.1016/s1081-1206(10)61482-2.
- Zuberbier T, Bindslev-Jensen C, Canonica W, Grattan CE, Greaves MW, Henz BM, Kapp A, Kozel MM, Maurer M, Merk HF, Schafer T, Simon D, Vena GA, Wedi B; EAACI/GA2LEN/EDF. EAACI/GA2LEN/EDF guideline: definition, classification and diagnosis of urticaria. Allergy. 2006 Mar;61(3):316-20. doi: 10.1111/j.1398-9995.2005.00964.x.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年7月1日
初级完成 (实际的)
2011年3月1日
研究完成 (实际的)
2011年3月1日
研究注册日期
首次提交
2010年1月11日
首先提交符合 QC 标准的
2010年1月11日
首次发布 (估计)
2010年1月12日
研究记录更新
最后更新发布 (实际的)
2018年2月20日
上次提交的符合 QC 标准的更新
2018年2月16日
最后验证
2011年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.