ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress Intervention for Chronic Urticaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01111136
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : November 25, 2010
Sponsor:
Information provided by:
University of Mississippi Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Urticaria Behavioral: Stress intervention Not Applicable

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  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Effect of Psychological Stress Intervention for Patients With Chronic Urticaria
Study Start Date : March 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Urticaria Activity Score [ Time Frame: 7 weeks ]
    Measures the daily level of skin itching and the number of hives as the study progresses.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: November 25, 2010
Last Verified: November 2010

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

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