Stress Intervention for Chronic Urticaria
This study has been completed.
Sponsor:
University of Mississippi Medical Center
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01111136
First received: April 23, 2010
Last updated: November 23, 2010
Last verified: November 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 23, 2010 | ||||||||
| Last Updated Date | November 23, 2010 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01111136 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Stress Intervention for Chronic Urticaria | ||||||||
| Official Title ICMJE | Effect of Psychological Stress Intervention for Patients With Chronic Urticaria | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Urticaria | ||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: stress intervention
Stress intervention.
Intervention: Behavioral: Stress intervention |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 4 | ||||||||
| Completion Date | July 2010 | ||||||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 64 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01111136 | ||||||||
| Other Study ID Numbers ICMJE | 2010-0052 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | John W. Tole, D.O., University of Mississippi Medical Center | ||||||||
| Study Sponsor ICMJE | University of Mississippi Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Mississippi Medical Center | ||||||||
| Verification Date | November 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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