Chronic UrticariaNCT01047137
Response of Urticaria to Stress Intervention
A study testing Psychological Stress Intervention and General Supportive Therapy in people with Chronic Urticaria, run by University of Mississippi Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- Psychological Stress Intervention and General Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Mississippi
Jackson, Mississippi, 39216
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Urticaria
- Being tested
- Psychological Stress Intervention, General Supportive Therapy
- Keywords
- Urticaria, Hives, Stress, Immune dysregulation
- Medical subject headings
- Chronic Urticaria, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Stress InterventionBehavioural
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.
General Supportive TherapyBehavioural
There is no focus on stress intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Behavioral: General Supportive Therapy |
| Intervention | Experimental | Participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques. Receives: Behavioral: Psychological Stress Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
Measured: 6 weeks
Secondary outcomes (3)
Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.
Measured: 6 weeks
Evaluate pre- and post-intervention cytokine and stress hormone levels.
Measured: 6 weeks
The number of as-needed antihistamines used as the study progresses.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: No patients enrolled. A pilot study variation of this study was done instead.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W Tole, D.O., Principal investigator, University of Mississippi Medical Center Div of Allergy and ImmunologyGailen D Marshall, M.D., Study director, University of Mississippi Medical Center Div of Allergy and ImmunologyKim L Gratz, Ph.D., Study director, University of Mississippi Medical Center Div of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047137
- Sponsor's protocol ID
- 2009-0013
- Status last verified
- Aug 2011
- First submitted
- 11 Jan 2010
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Powell RJ, Du Toit GL, Siddique N, Leech SC, Dixon TA, Clark AT, Mirakian R, Walker SM, Huber PA, Nasser SM; British Society for Allergy and Clinical Immunology (BSACI). BSACI guidelines for the management of chronic urticaria and angio-oedema. Clin Exp Allergy. 2007 May;37(5):631-50. doi: 10.1111/j.1365-2222.2007.02678.x.
PubMed 17456211Sperber J, Shaw J, Bruce S. Psychological components and the role of adjunct interventions in chronic idiopathic urticaria. Psychother Psychosom. 1989;51(3):135-41. doi: 10.1159/000288147.
PubMed 2636418Papadopoulou N, Kalogeromitros D, Staurianeas NG, Tiblalexi D, Theoharides TC. Corticotropin-releasing hormone receptor-1 and histidine decarboxylase expression in chronic urticaria. J Invest Dermatol. 2005 Nov;125(5):952-5. doi: 10.1111/j.0022-202X.2005.23913.x.
PubMed 16297195Yang HY, Sun CC, Wu YC, Wang JD. Stress, insomnia, and chronic idiopathic urticaria--a case-control study. J Formos Med Assoc. 2005 Apr;104(4):254-63.
PubMed 15909063Ozkan M, Oflaz SB, Kocaman N, Ozseker F, Gelincik A, Buyukozturk S, Ozkan S, Colakoglu B. Psychiatric morbidity and quality of life in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2007 Jul;99(1):29-33. doi: 10.1016/S1081-1206(10)60617-5.
PubMed 17650826Silvares MR, Coelho KI, Dalben I, Lastoria JC, Abbade LP. Sociodemographic and clinical characteristics, causal factors and evolution of a group of patients with chronic urticaria-angioedema. Sao Paulo Med J. 2007 Sep 6;125(5):281-5. doi: 10.1590/s1516-31802007000500006.
PubMed 18094895Berrino AM, Voltolini S, Fiaschi D, Pellegrini S, Bignardi D, Minale P, Troise C, Maura E. Chronic urticaria: importance of a medical-psychological approach. Eur Ann Allergy Clin Immunol. 2006 May;38(5):149-52.
PubMed 17058846Annesi-Maesano I, Beyer A, Marmouz F, Mathelier-Fusade P, Vervloet D, Bauchau V. Do patients with skin allergies have higher levels of anxiety than patients with allergic respiratory diseases? Results of a large-scale cross-sectional study in a French population. Br J Dermatol. 2006 Jun;154(6):1128-36. doi: 10.1111/j.1365-2133.2006.07186.x.
PubMed 16704645Marshall GD. Neuroendocrine mechanisms of immune dysregulation: applications to allergy and asthma. Ann Allergy Asthma Immunol. 2004 Aug;93(2 Suppl 1):S11-7. doi: 10.1016/s1081-1206(10)61482-2.
PubMed 15330008Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
PubMed 3393032Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PubMed 8033378Zuberbier T, Bindslev-Jensen C, Canonica W, Grattan CE, Greaves MW, Henz BM, Kapp A, Kozel MM, Maurer M, Merk HF, Schafer T, Simon D, Vena GA, Wedi B; EAACI/GA2LEN/EDF. EAACI/GA2LEN/EDF guideline: definition, classification and diagnosis of urticaria. Allergy. 2006 Mar;61(3):316-20. doi: 10.1111/j.1398-9995.2005.00964.x.
PubMed 16436140
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation
- ClinicalTrials.gov ID
- NCT01047137
- Acronym / sponsor ID
- 2009-0013
- Conditions
- Chronic Urticaria
- Keywords
- Urticaria, Hives, Stress, Immune dysregulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled. A pilot study variation of this study was done instead.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: General Supportive TherapyParticipants will meet with a psychiatry resident once a week for six consecutive weeks for general supportive therapy, which will not provide psychological stress intervention. |
| Intervention | Experimental | Behavioral: Psychological Stress InterventionParticipants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Stress InterventionIntervention 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. | Behavioural | Intervention |
| General Supportive TherapyThere is no focus on stress intervention. | Behavioural | Control |
Primary outcome
Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score
Time frame: 6 weeks
3 secondary outcomes
Comparison of the pre-intervention and post-intervention symptoms as determined by a packet of psychological and dermatological questionnaires.
Time frame: 6 weeks
Evaluate pre- and post-intervention cytokine and stress hormone levels.
Time frame: 6 weeks
The number of as-needed antihistamines used as the study progresses.
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Background: PubMed 17456211Powell RJ, Du Toit GL, Siddique N, Leech SC, Dixon TA, Clark AT, Mirakian R, Walker SM, Huber PA, Nasser SM; British Society for Allergy and Clinical Immunology (BSACI). BSACI guidelines for the management of chronic urticaria and angio-oedema. Clin Exp Allergy. 2007 May;37(5):631-50. doi: 10.1111/j.1365-2222.2007.02678.x.
- Background: PubMed 2636418Sperber J, Shaw J, Bruce S. Psychological components and the role of adjunct interventions in chronic idiopathic urticaria. Psychother Psychosom. 1989;51(3):135-41. doi: 10.1159/000288147.
- Background: PubMed 16297195Papadopoulou N, Kalogeromitros D, Staurianeas NG, Tiblalexi D, Theoharides TC. Corticotropin-releasing hormone receptor-1 and histidine decarboxylase expression in chronic urticaria. J Invest Dermatol. 2005 Nov;125(5):952-5. doi: 10.1111/j.0022-202X.2005.23913.x.
- Background: PubMed 15909063Yang HY, Sun CC, Wu YC, Wang JD. Stress, insomnia, and chronic idiopathic urticaria--a case-control study. J Formos Med Assoc. 2005 Apr;104(4):254-63.
- Background: PubMed 17650826Ozkan M, Oflaz SB, Kocaman N, Ozseker F, Gelincik A, Buyukozturk S, Ozkan S, Colakoglu B. Psychiatric morbidity and quality of life in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2007 Jul;99(1):29-33. doi: 10.1016/S1081-1206(10)60617-5.
- Background: PubMed 18094895Silvares MR, Coelho KI, Dalben I, Lastoria JC, Abbade LP. Sociodemographic and clinical characteristics, causal factors and evolution of a group of patients with chronic urticaria-angioedema. Sao Paulo Med J. 2007 Sep 6;125(5):281-5. doi: 10.1590/s1516-31802007000500006.
- Background: PubMed 17058846Berrino AM, Voltolini S, Fiaschi D, Pellegrini S, Bignardi D, Minale P, Troise C, Maura E. Chronic urticaria: importance of a medical-psychological approach. Eur Ann Allergy Clin Immunol. 2006 May;38(5):149-52.
- Background: PubMed 16704645Annesi-Maesano I, Beyer A, Marmouz F, Mathelier-Fusade P, Vervloet D, Bauchau V. Do patients with skin allergies have higher levels of anxiety than patients with allergic respiratory diseases? Results of a large-scale cross-sectional study in a French population. Br J Dermatol. 2006 Jun;154(6):1128-36. doi: 10.1111/j.1365-2133.2006.07186.x.
- Background: PubMed 15330008Marshall GD. Neuroendocrine mechanisms of immune dysregulation: applications to allergy and asthma. Ann Allergy Asthma Immunol. 2004 Aug;93(2 Suppl 1):S11-7. doi: 10.1016/s1081-1206(10)61482-2.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 3393032Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
- Background: PubMed 8033378Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Tole, D.O. principal investigator
University of Mississippi Medical Center Div of Allergy and Immunology
Gailen D Marshall, M.D. study director
University of Mississippi Medical Center Div of Allergy and Immunology
Kim L Gratz, Ph.D. study director
University of Mississippi Medical Center Div of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Stress Intervention and General Supportive Therapy in people with Chronic Urticaria, run by University of Mississippi Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect psychological stress intervention has on chronic urticaria as measured by the Urticaria Activity Score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047137, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.