Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
研究概览
简要总结
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.
详细描述
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: General Supportive Therapy (Behavioral)
Intervention
Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques.
干预措施: Psychological Stress Intervention (Behavioral)
结局指标
主要结局
Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
时间窗: 6 weeks
次要结局
- Evaluate pre- and post-intervention cytokine and stress hormone levels.(6 weeks)
- The number of as-needed antihistamines used as the study progresses.(6 weeks)
- Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.(6 weeks)