Stress Intervention for Chronic Urticaria

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Psychological Stress Intervention for Patients With Chronic Urticaria

Conditions
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Chronic Urticaria

Intervention / Treatment
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* Behavioral: Stress intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Urticaria secondary to vasculitis. Urticaria as part of an anaphylactic response. Use of Omalizumab within 3 months preceding enrollment period.

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
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stress intervention<br>Stress intervention. | Behavioral: Stress intervention<br>* To evaluate psychological stress, participants will complete the Perceived Stress Scale, Beck Depression Inventory-Fast Screen, Anxiety Sensitivity Index-III, Posttraumatic Stress Diagnostic Scale and the Depression Anxiety Stress Scales; to evaluate cognitive and behavioral aspects of emotional avoidance, participants will complete the Emotional Avoidance Questionnaire as well as the Acceptance and Action Questionnaire, Difficulties in Emotion Regulation Scale, Illness Attitudes Scale and the Five Facet Mindfulness Questionnaire; and to evaluate quality of life in regards to his/her skin condition, participants will complete the Dermatology Life Quality Index questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urticaria Activity Score | Measures the daily level of skin itching and the number of hives as the study progresses. | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of stress. | A set of questionnaires done before the first session and after the sixth/final session will be done to compare level of stress. | 7 weeks | 

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