Response of Urticaria to Stress Intervention

NCT01047137 | Withdrawn

• 1 other identifier: 2009-0013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Urticaria

Keywords

Urticaria; Hives; Stress; Immune dysregulation

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score

  6 weeks

Secondary Outcomes (3)

• Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.

  6 weeks

• Evaluate pre- and post-intervention cytokine and stress hormone levels.

  6 weeks

• The number of as-needed antihistamines used as the study progresses.

  6 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Intervention

EXPERIMENTAL

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

Interventions

Psychological Stress Intervention BEHAVIORAL

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.

Intervention

General Supportive Therapy BEHAVIORAL

There is no focus on stress intervention.

Control

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 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (2)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Related Publications (13)

• 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

• 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.

  PMID: 15330008 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 3393032 BACKGROUND

• 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.

  PMID: 8033378 BACKGROUND

• 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.

  PMID: 16436140 BACKGROUND

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

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

Study Officials

• John W Tole, D.O.

  University of Mississippi Medical Center Div of Allergy and Immunology

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 20, 2018

Record last verified: 2011-08

Locations

US (2)