Clinical trial NCT01047137: Response of Urticaria to Stress Intervention
Official title: Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Urticaria
Keywords: Urticaria
Hives
Stress
Immune dysregulation
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.
timeFrame: 6 weeks
measure: Evaluate pre- and post-intervention cytokine and stress hormone levels.
timeFrame: 6 weeks
measure: The number of as-needed antihistamines used as the study progresses.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center Div of Allergy and Immunology
name: John W Tole, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center Div of Allergy and Immunology
name: Gailen D Marshall, M.D.
role: STUDY_DIRECTOR
affiliation: University of Mississippi Medical Center Div of Psychiatry
name: Kim L Gratz, Ph.D.
role: STUDY_DIRECTOR
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