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Stress Intervention for Chronic Urticaria

Primary Purpose

Chronic Urticaria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress intervention
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Urticaria focused on measuring Urticaria, Hives, Stress

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stress intervention

Arm Description

Stress intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Level of stress.
A set of questionnaires done before the first session and after the sixth/final session will be done to compare level of stress.

Full Information

First Posted
April 23, 2010
Last Updated
November 23, 2010
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01111136
Brief Title
Stress Intervention for Chronic Urticaria
Official Title
Effect of Psychological Stress Intervention for Patients With Chronic Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The purpose of this single-arm, interventional pilot study is to evaluate the effect of psychological stress intervention for patients with chronic urticaria, as many of these patients report heightened levels of stress before and/or after the onset of the urticaria. Participants will meet individually with a University of Mississippi Medical Center psychiatry resident for one hour once a week for six consecutive weeks to be educated on psychological stress intervention techniques. There is no control group for this pilot study. 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 medications taken for his/her chronic hives. If psychological stress intervention proves to be effective, then this therapeutic modality would benefit patients with chronic urticaria, while avoiding addition and/or continuation of medications that may have significant adverse side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria
Keywords
Urticaria, Hives, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stress intervention
Arm Type
Experimental
Arm Description
Stress intervention.
Intervention Type
Behavioral
Intervention Name(s)
Stress intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urticaria Activity Score
Description
Measures the daily level of skin itching and the number of hives as the study progresses.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Level of stress.
Description
A set of questionnaires done before the first session and after the sixth/final session will be done to compare level of stress.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Urticaria secondary to vasculitis. Urticaria as part of an anaphylactic response. Use of Omalizumab within 3 months preceding enrollment period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W. Tole, D.O.
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gailen D. Marshall, MD, PhD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17456211
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. doi: 10.1111/j.1365-2222.2007.02678.x.
Results Reference
background
PubMed Identifier
2636418
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. doi: 10.1159/000288147.
Results Reference
background
PubMed Identifier
16297195
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. doi: 10.1111/j.0022-202X.2005.23913.x.
Results Reference
background
PubMed Identifier
15909063
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.
Results Reference
background
PubMed Identifier
17650826
Citation
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.
Results Reference
background
PubMed Identifier
18094895
Citation
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.
Results Reference
background
PubMed Identifier
17058846
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.
Results Reference
background
PubMed Identifier
16704645
Citation
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.
Results Reference
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Stress Intervention for Chronic Urticaria

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