Clinical trial NCT01111136: Stress Intervention for Chronic Urticaria
Official title: Effect of Psychological Stress Intervention for Patients With Chronic Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Urticaria
Keywords: Urticaria
Hives
Stress
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2010-04-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urticaria Activity Score
timeFrame: 7 weeks
Secondary outcomes:
measure: Level of stress.
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: John W. Tole, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center
name: Gailen D. Marshall, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: Berrino AM, Voltolini S, Fiaschi D, Pellegrini S, Bignardi D, Minale P, Troise C, Maura E. Chronic urticaria: importance of a medical-psychological approach. Eur Ann Allergy Clin Immunol. 2006 May;38(5):149-52.
citation: Annesi-Maesano I, Beyer A, Marmouz F, Mathelier-Fusade P, Vervloet D, Bauchau V. Do patients with skin allergies have higher levels of anxiety than patients with allergic respiratory diseases? Results of a large-scale cross-sectional study in a French population. Br J Dermatol. 2006 Jun;154(6):1128-36. doi: 10.1111/j.1365-2133.2006.07186.x.