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临床试验/NCT01111136
NCT01111136已完成不适用

Effect of Psychological Stress Intervention for Patients With Chronic Urticaria

University of Mississippi Medical Center2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Urticaria Activity Score

研究概览

简要总结

Stress and chronic urticaria has been linked. The purpose of the study is to evaluate a patients chronic urticaria and stress levels before and after he/she goes through six sessions designed to help that participant manage his/her stress.

详细描述

The purpose of this single-arm, interventional pilot study is to evaluate the effect of psychological stress intervention for patients with chronic urticaria, as many of these patients report heightened levels of stress before and/or after the onset of the urticaria. Participants will meet individually with a University of Mississippi Medical Center psychiatry resident for one hour once a week for six consecutive weeks to be educated on psychological stress intervention techniques. There is no control group for this pilot study. 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 medications taken for his/her chronic hives. If psychological stress intervention proves to be effective, then this therapeutic modality would benefit patients with chronic urticaria, while avoiding addition and/or continuation of medications that may have significant adverse side effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females age 18-64 years old who have had hives for longer than 6 weeks.
  • Hives persist despite medical therapy.
  • Minimum Urticaria Activity Score of 2 (one point from each of the two categories: number of hives and severity of pruritus).

排除标准

  • Urticaria secondary to vasculitis.
  • Urticaria as part of an anaphylactic response.
  • Use of Omalizumab within 3 months preceding enrollment period.

结局指标

主要结局

Urticaria Activity Score

时间窗: 7 weeks

Measures the daily level of skin itching and the number of hives as the study progresses.

次要结局

  • Level of stress.(7 weeks)

研究者

申办方类型
Other

研究点 (2)

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