Stress Intervention for Chronic Urticaria

NCT01111136 | Completed

• 1 other identifier: 2010-0052
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Stress and chronic urticaria has been linked. The purpose of the study is to evaluate a patients chronic urticaria and stress levels before and after he/she goes through six sessions designed to help that participant manage his/her stress.

Conditions

Chronic Urticaria

Keywords

Urticaria; Hives; Stress

Outcome Measures

Primary Outcomes (1)

• Urticaria Activity Score

  Measures the daily level of skin itching and the number of hives as the study progresses.

  7 weeks

Secondary Outcomes (1)

• Level of stress.

  7 weeks

Study Arms (1)

stress intervention

EXPERIMENTAL

Stress intervention.

Behavioral: Stress intervention

Interventions

Stress intervention BEHAVIORAL

To evaluate psychological stress, participants will complete the Perceived Stress Scale, Beck Depression Inventory-Fast Screen, Anxiety Sensitivity Index-III, Posttraumatic Stress Diagnostic Scale and the Depression Anxiety Stress Scales; to evaluate cognitive and behavioral aspects of emotional avoidance, participants will complete the Emotional Avoidance Questionnaire as well as the Acceptance and Action Questionnaire, Difficulties in Emotion Regulation Scale, Illness Attitudes Scale and the Five Facet Mindfulness Questionnaire; and to evaluate quality of life in regards to his/her skin condition, participants will complete the Dermatology Life Quality Index questionnaire.

stress intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females age 18-64 years old who have had hives for longer than 6 weeks.
• Hives persist despite medical therapy.
• Minimum Urticaria Activity Score of 2 (one point from each of the two categories: number of hives and severity of pruritus).

You may not qualify if:

• Urticaria secondary to vasculitis.
• Urticaria as part of an anaphylactic response.
• Use of Omalizumab within 3 months preceding enrollment period.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (8)

• 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. doi: 10.1111/j.1365-2222.2007.02678.x.

  PMID: 17456211 BACKGROUND

• 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.

  PMID: 2636418 BACKGROUND

• 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.

  PMID: 16297195 BACKGROUND

• 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.

  PMID: 15909063 BACKGROUND

• 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.

  PMID: 17650826 BACKGROUND

• 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.

  PMID: 18094895 BACKGROUND

• 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.

  PMID: 17058846 BACKGROUND

• 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.

  PMID: 16704645 BACKGROUND

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John W. Tole, D.O.

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

• Gailen D. Marshall, MD, PhD

  University of Mississippi Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 25, 2010

Record last verified: 2010-11

Locations

US (1)