Response of Urticaria to Stress Intervention

University of Mississippi Medical Center

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Chronic Urticaria

Interventions

Psychological Stress InterventionBEHAVIORAL

Intervention group participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques focusing on relaxation, mindfulness, emotion regulation and acceptance and willingness.

General Supportive TherapyBEHAVIORAL

There is no focus on stress intervention.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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).

Locations (2)

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Mississippi

Jackson, Mississippi, United States

Outcomes

Primary Outcomes

Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score

Time frame: 6 weeks

Secondary Outcomes

Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.

Time frame: 6 weeks

Evaluate pre- and post-intervention cytokine and stress hormone levels.

Time frame: 6 weeks

The number of as-needed antihistamines used as the study progresses.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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