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Stress Intervention for Chronic Urticaria

This study has been completed.
Sponsor:
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01111136
First received: April 23, 2010
Last updated: November 23, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Chronic Urticaria
Behavioral: Stress intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Effect of Psychological Stress Intervention for Patients With Chronic Urticaria

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Urticaria Activity Score [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Measures the daily level of skin itching and the number of hives as the study progresses.


Secondary Outcome Measures:
  • Level of stress. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    A set of questionnaires done before the first session and after the sixth/final session will be done to compare level of stress.


Enrollment: 4
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stress intervention
Stress intervention.
Behavioral: Stress intervention
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.

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111136

Locations
United States, Mississippi
University of Mississippi Medical Center
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
Study Director: Gailen D. Marshall, MD, PhD University of Mississippi Medical Center
  More Information

Publications:

Responsible Party: John W. Tole, D.O., University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01111136     History of Changes
Other Study ID Numbers: 2010-0052
Study First Received: April 23, 2010
Last Updated: November 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Urticaria
Hives
Stress

Additional relevant MeSH terms:
Urticaria
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Vascular

ClinicalTrials.gov processed this record on November 25, 2014