Response of Urticaria to Stress Intervention

Chronic Urticaria Clinical Trial

Official title:

Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01047137
• Other study ID #: 2009-0013
• Status: Withdrawn
• Phase: N/A
• First received: January 11, 2010
• Last updated: February 16, 2018
• Start date: July 2010
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Intervention

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.
• General Supportive Therapy
There is no focus on stress intervention.

Locations

Country	Name	City	State
United States	University of Mississippi	Jackson	Mississippi
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

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. — View Citation

Marshall GD. Neuroendocrine mechanisms of immune dysregulation: applications to allergy and asthma. Ann Allergy Asthma Immunol. 2004 Aug;93(2 Suppl 1):S11-7. Review. — View Citation

Ozkan M, Oflaz SB, Kocaman N, Ozseker F, Gelincik A, Büyüköztürk 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. — View Citation

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. — View Citation

Powell RJ, Du Toit GL, Siddique N, Leech SC, Dixon TA, Clark AT, Mirakian R, Walker SM, Huber PA, Nasser SM; British Society for Allergy and Clinical Immunology (BSACI). BSACI guidelines for the management of chronic urticaria and angio-oedema. Clin Exp Allergy. 2007 May;37(5):631-50. — View Citation

Silvares MR, Coelho KI, Dalben I, Lastória 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Zuberbier T, Bindslev-Jensen C, Canonica W, Grattan CE, Greaves MW, Henz BM, Kapp A, Kozel MM, Maurer M, Merk HF, Schäfer 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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score		6 weeks
Secondary	Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.		6 weeks
Secondary	Evaluate pre- and post-intervention cytokine and stress hormone levels.		6 weeks
Secondary	The number of as-needed antihistamines used as the study progresses.		6 weeks