Response of Urticaria to Stress Intervention

This study has been withdrawn prior to enrollment.
(No patients enrolled. A pilot study variation of this study was done instead.)
Sponsor:
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01047137
First received: January 11, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Chronic Urticaria
Behavioral: Psychological Stress Intervention
Behavioral: General Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluate pre- and post-intervention cytokine and stress hormone levels. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • The number of as-needed antihistamines used as the study progresses. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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 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).
  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: NCT01047137

Locations
United States, Massachusetts
University of Mississippi Medical Center
Jackson, Massachusetts, United States, 39216
United States, Mississippi
University of Mississippi
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 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
  More Information

Publications:

Responsible Party: John W. Tole, D.O., University of Mississippi Medical Center Division of Allergy and Immunology
ClinicalTrials.gov Identifier: NCT01047137     History of Changes
Other Study ID Numbers: 2009-0013
Study First Received: January 11, 2010
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014