Response of Urticaria to Stress Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation

Conditions
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Chronic Urticaria

Intervention / Treatment
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* Behavioral: Psychological Stress Intervention
* Behavioral: General Supportive Therapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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. | Behavioral: General Supportive Therapy<br>* There is no focus on stress intervention.<br>|
| Experimental: Intervention<br>Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques. | Behavioral: Psychological Stress Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires. |  | 6 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urticaria, Hives, Stress, Immune dysregulation