Response of Urticaria to Stress Intervention

February 16, 2018 updated by: University of Mississippi Medical Center

Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

As many patients with chronic urticaria display heightened levels of stress before and/or after the onset of the urticaria, the purpose of this study is to evaluate the effect of psychological stress intervention on chronic urticaria. Intervention group participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques. Control group 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. 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 antihistamines taken. Blood and saliva samples will be collected before the first session and one week after completion of the final session to compare the levels of stress hormones and cytokines in order to evaluate an effect on immune dysregulation.

Study Type

Interventional

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

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 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).

Exclusion Criteria:

  • 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).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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
There is no focus on stress intervention.
Experimental: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.
Time Frame: 6 weeks
6 weeks
Evaluate pre- and post-intervention cytokine and stress hormone levels.
Time Frame: 6 weeks
6 weeks
The number of as-needed antihistamines used as the study progresses.
Time Frame: 6 weeks
6 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 Div of Allergy and Immunology
  • Study Director: 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

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

July 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0013

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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