Stress Intervention for Chronic Urticaria

Not Applicable

Completed

• Conditions: Chronic Urticaria
• Interventions: Behavioral: Stress intervention

• Registration Number: NCT01111136
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-23
• Last Update Posted: 2010-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stress intervention	Stress intervention	Stress intervention.

Primary Outcome Measures

Name	Time	Method
Urticaria Activity Score	7 weeks	Measures the daily level of skin itching and the number of hives as the study progresses.

Secondary Outcome Measures

Name	Time	Method
Level of stress.	7 weeks	A set of questionnaires done before the first session and after the sixth/final session will be done to compare level of stress.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States