Response of Urticaria to Stress Intervention

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.

Full Title of Study: “Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2011

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.

Interventions

  • Behavioral: Psychological Stress Intervention
    • 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.
  • Behavioral: General Supportive Therapy
    • There is no focus on stress intervention.

Arms, Groups and Cohorts

  • Placebo Comparator: Control
    • 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.
  • Experimental: Intervention
    • Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques.

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
    • Time Frame: 6 weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Mississippi Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John W Tole, D.O., Principal Investigator, University of Mississippi Medical Center Div of Allergy and Immunology
    • Gailen D Marshall, M.D., Study Director, University of Mississippi Medical Center Div of Allergy and Immunology
    • Kim L Gratz, Ph.D., Study Director, University of Mississippi Medical Center Div of Psychiatry

References

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Sperber J, Shaw J, Bruce S. Psychological components and the role of adjunct interventions in chronic idiopathic urticaria. Psychother Psychosom. 1989;51(3):135-41. doi: 10.1159/000288147.

Papadopoulou N, Kalogeromitros D, Staurianeas NG, Tiblalexi D, Theoharides TC. Corticotropin-releasing hormone receptor-1 and histidine decarboxylase expression in chronic urticaria. J Invest Dermatol. 2005 Nov;125(5):952-5. doi: 10.1111/j.0022-202X.2005.23913.x.

Yang HY, Sun CC, Wu YC, Wang JD. Stress, insomnia, and chronic idiopathic urticaria–a case-control study. J Formos Med Assoc. 2005 Apr;104(4):254-63.

Ozkan M, Oflaz SB, Kocaman N, Ozseker F, Gelincik A, Buyukozturk S, Ozkan S, Colakoglu B. Psychiatric morbidity and quality of life in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2007 Jul;99(1):29-33. doi: 10.1016/S1081-1206(10)60617-5.

Silvares MR, Coelho KI, Dalben I, Lastoria JC, Abbade LP. Sociodemographic and clinical characteristics, causal factors and evolution of a group of patients with chronic urticaria-angioedema. Sao Paulo Med J. 2007 Sep 6;125(5):281-5. doi: 10.1590/s1516-31802007000500006.

Berrino AM, Voltolini S, Fiaschi D, Pellegrini S, Bignardi D, Minale P, Troise C, Maura E. Chronic urticaria: importance of a medical-psychological approach. Eur Ann Allergy Clin Immunol. 2006 May;38(5):149-52.

Annesi-Maesano I, Beyer A, Marmouz F, Mathelier-Fusade P, Vervloet D, Bauchau V. Do patients with skin allergies have higher levels of anxiety than patients with allergic respiratory diseases? Results of a large-scale cross-sectional study in a French population. Br J Dermatol. 2006 Jun;154(6):1128-36. doi: 10.1111/j.1365-2133.2006.07186.x.

Marshall GD. Neuroendocrine mechanisms of immune dysregulation: applications to allergy and asthma. Ann Allergy Asthma Immunol. 2004 Aug;93(2 Suppl 1):S11-7. doi: 10.1016/s1081-1206(10)61482-2.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

Zuberbier T, Bindslev-Jensen C, Canonica W, Grattan CE, Greaves MW, Henz BM, Kapp A, Kozel MM, Maurer M, Merk HF, Schafer T, Simon D, Vena GA, Wedi B; EAACI/GA2LEN/EDF. EAACI/GA2LEN/EDF guideline: definition, classification and diagnosis of urticaria. Allergy. 2006 Mar;61(3):316-20. doi: 10.1111/j.1398-9995.2005.00964.x.

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