Response of Urticaria to Stress Intervention

University of Mississippi

Status: Withdrawn

Conditions: Chronic Urticaria

Treatments: Behavioral: Psychological Stress Intervention; Behavioral: General Supportive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01047137

2009-0013

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: General Supportive Therapy

Intervention

Experimental group

Description:

Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques.

Treatment:

Behavioral: Psychological Stress Intervention