Stress Intervention for 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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Effect of Psychological Stress Intervention for Patients With Chronic Urticaria|
- Urticaria Activity Score [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]Measures the daily level of skin itching and the number of hives as the study progresses.
- Level of stress. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]A set of questionnaires done before the first session and after the sixth/final session will be done to compare level of stress.
|Study Start Date:||March 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111136
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||John W. Tole, D.O.||University of Mississippi Medical Center|
|Study Director:||Gailen D. Marshall, MD, PhD||University of Mississippi Medical Center|