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Clinical Trials/NCT01111136
NCT01111136
Completed
Not Applicable

Effect of Psychological Stress Intervention for Patients With Chronic Urticaria

University of Mississippi Medical Center1 site in 1 country4 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Urticaria
Sponsor
University of Mississippi Medical Center
Enrollment
4
Locations
1
Primary Endpoint
Urticaria Activity Score
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
July 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

Urticaria Activity Score

Time Frame: 7 weeks

Measures the daily level of skin itching and the number of hives as the study progresses.

Secondary Outcomes

  • Level of stress.(7 weeks)

Study Sites (1)

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