Stress Intervention for Chronic Urticaria

November 23, 2010 updated by: University of Mississippi Medical Center

Effect of Psychological Stress Intervention for Patients With Chronic Urticaria

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urticaria Activity Score
Time Frame: 7 weeks
Measures the daily level of skin itching and the number of hives as the study progresses.
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of stress.
Time Frame: 7 weeks
A set of questionnaires done before the first session and after the sixth/final session will be done to compare level of stress.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2010

Last Update Submitted That Met QC Criteria

November 23, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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