Response of Urticaria to Stress Intervention - Full Text View

Purpose

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.

Condition	Intervention
Chronic Urticaria	Behavioral: Psychological Stress Intervention Behavioral: General Supportive Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation

Resource links provided by NLM:

MedlinePlus related topics: Hives Stress

U.S. FDA Resources

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:

Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evaluate pre- and post-intervention cytokine and stress hormone levels. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The number of as-needed antihistamines used as the study progresses. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2010
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Behavioral: General Supportive Therapy There is no focus on 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.	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.

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

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047137

Locations

United States, Massachusetts
University of Mississippi Medical Center
Jackson, Massachusetts, United States, 39216
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39216

Sponsors and Collaborators

University of Mississippi Medical Center

Investigators

Principal Investigator:	John W Tole, D.O.	University of Mississippi Medical Center Div of Allergy and Immunology
Study Director:	Gailen D Marshall, M.D.	University of Mississippi Medical Center Div of Allergy and Immunology
Study Director:	Kim L Gratz, Ph.D.	University of Mississippi Medical Center Div of Psychiatry

More Information

Publications:

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.

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.

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.

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, Büyüköztürk S, Ozkan S, Colako?lu B. Psychiatric morbidity and quality of life in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2007 Jul;99(1):29-33.

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.

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.

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.

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. 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.

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.

Responsible Party:	John W. Tole, D.O., University of Mississippi Medical Center Division of Allergy and Immunology
ClinicalTrials.gov Identifier:	NCT01047137 History of Changes
Other Study ID Numbers:	2009-0013
Study First Received:	January 11, 2010
Last Updated:	August 2, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:

Urticaria
Hives
Stress
Immune dysregulation

Additional relevant MeSH terms:

Stress, Psychological
Urticaria
Behavioral Symptoms
Skin Diseases, Vascular

Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013