Response of Urticaria to Stress Intervention

Not Applicable

Withdrawn

• Conditions: Chronic Urticaria
• Interventions: Behavioral: General Supportive Therapy; Behavioral: Psychological Stress Intervention

• Registration Number: NCT01047137
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Study Start: 2010-07
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-08
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	General Supportive Therapy	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.
Intervention	Psychological Stress Intervention	Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques.

Primary Outcome Measures

Name	Time	Method
Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score	6 weeks

Secondary Outcome Measures

Name	Time	Method
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
Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.	6 weeks

Trial Locations

Locations (2)

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

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