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Response of Urticaria to Stress Intervention

Primary Purpose

Chronic Urticaria

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychological Stress Intervention
General Supportive Therapy
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Urticaria focused on measuring Urticaria, Hives, Stress, Immune dysregulation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Mississippi Medical Center
  • University of Mississippi

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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.

Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques.

Outcomes

Primary Outcome Measures

Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score

Secondary Outcome Measures

Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.
Evaluate pre- and post-intervention cytokine and stress hormone levels.
The number of as-needed antihistamines used as the study progresses.

Full Information

First Posted
January 11, 2010
Last Updated
February 16, 2018
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01047137
Brief Title
Response of Urticaria to Stress Intervention
Official Title
Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled. A pilot study variation of this study was done instead.
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria
Keywords
Urticaria, Hives, Stress, Immune dysregulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques.
Intervention Type
Behavioral
Intervention Name(s)
Psychological Stress Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General Supportive Therapy
Intervention Description
There is no focus on stress intervention.
Primary Outcome Measure Information:
Title
Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.
Time Frame
6 weeks
Title
Evaluate pre- and post-intervention cytokine and stress hormone levels.
Time Frame
6 weeks
Title
The number of as-needed antihistamines used as the study progresses.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Tole, D.O.
Organizational Affiliation
University of Mississippi Medical Center Div of Allergy and Immunology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gailen D Marshall, M.D.
Organizational Affiliation
University of Mississippi Medical Center Div of Allergy and Immunology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kim L Gratz, Ph.D.
Organizational Affiliation
University of Mississippi Medical Center Div of Psychiatry
Official's Role
Study Director
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

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Response of Urticaria to Stress Intervention

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