Comparison of the Effects of Stress Management Combined with Pharmacotherapy versus Pharmacotherapy as Sole Treatment on Quality of Life in Patients with Chronic Urticaria
Evaluating the Effect of Combined Stress-Management Therapy and Pharmacotherapy Compared to Pharmacotherapy Alone on the Quality of Life of Patients with Chronic Urticaria.
Design
Patients who had been referred for treatment of chronic urticaria within a few weeks before the start of the study and who currently had active disease were invited to participate in the study. Patients were divided into two groups, case and control, based on personal preference. In addition to drug therapy, the case group received 8 weeks of psychotherapy. The chronic urticaria questionnaire was completed for both groups before and after the intervention. After that, statistical analysis was performed on the two groups..
Settings and conduct
Two non-blinded groups of 50 patients each, selected from recent visitors to Dr. Pourvali’s clinic who had not responded clinically to previous pharmacotherapy. In the control group, only the treatment stage was escalated, while in the intervention group, in addition to the escalated treatment stage, eight weeks of psychotherapy were provided.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age over 12 years
Absence of severe chronic physical or psychological illnesses
Diagnosis of chronic spontaneous urticaria
Willingness and consent to participate in the study
Exclusion Criteria:
Incomplete questionnaire data or failure to attend the scheduled sessions.
Intervention groups
Intervention: Patients with chronic urticaria who receive both psychotherapy and pharmacological treatment for chronic urticaria.
Control: Patients with chronic urticaria who receive only pharmacological treatment for chronic urticaria
Main outcome variables
Quality of life of patients with chronic urticaria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250912067222N1
Registration date:2025-12-07, 1404/09/16
Registration timing:retrospective
Last update:2025-12-07, 1404/09/16
Update count:0
Registration date
2025-12-07, 1404/09/16
Registrant information
Name
Saeed Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8869 6323
Email address
dr.saeed.sadeghi@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-06, 1404/04/15
Expected recruitment end date
2025-09-06, 1404/06/15
Actual recruitment start date
2025-07-06, 1404/04/15
Actual recruitment end date
2025-09-06, 1404/06/15
Trial completion date
2025-09-11, 1404/06/20
Scientific title
Comparison of the Effects of Stress Management Combined with Pharmacotherapy versus Pharmacotherapy as Sole Treatment on Quality of Life in Patients with Chronic Urticaria
Public title
Effectiveness of stress management on the quality of life of patients with chronic diseases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of chronic spontaneous urticaria
Age 12 years and older
Absence of severe chronic physical or psychological illnesses
Ability to read and write in Persian
Willingness and informed consent to participate in the study
Exclusion criteria:
Failure to complete the questionnaires or absence from the scheduled sessions
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization at the individual level will be performed to assign participants into two groups: intervention and control. Since demographic characteristics are not expected to significantly affect the outcomes, stratification will not be applied. Assignment to the intervention group will be based on participants’ willingness to receive psychotherapy; those who wish to participate in the study without undergoing psychotherapy will be assigned to the control group. This study will not implement allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Tehran North Branch
Street address
Shahrak-e Gharb, Darya Boulevard, North Motahari Street, Shaghayegh 2 Alley, No. 8, Unit 10
City
Tehran
Province
Tehran
Postal code
1998879359
Approval date
2025-07-02, 1404/04/11
Ethics committee reference number
IR.IAU.TNB.REC.1404.113
Health conditions studied
1
Description of health condition studied
chronic urticaria
ICD-10 code
L50.1
ICD-10 code description
Idiopathic urticaria
Primary outcomes
1
Description
Quality of Life in Patients with Chronic Urticaria
Timepoint
Before the intervention and 8 weeks after treatment
Method of measurement
Chronic Urticaria Quality of Life Questionnaire
Secondary outcomes
1
Description
Urticaria Severity
Timepoint
Before the intervention and 8 weeks after
Method of measurement
Urticaria Activity Score in 7 days
Intervention groups
1
Description
Intervention group: Stress management, including mindfulness and relaxation exercises over 8 sessions, alongside standard treatment for chronic urticaria
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy Clinic
Full name of responsible person
Ali Pourvali
Street address
Allergy Clinic, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1997998394
Phone
+98 21 2208 3617
Email
a_pourvali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vice President for Research and Technology
Street address
Islamic Azad University, Chaman Ara Street, Hakimiyeh, Babayi Highway
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7700 9838
Email
ravabet-omomi@iau-tnb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data that researchers may need after de-identifying individuals.
When the data will become available and for how long
Possibility of access after publication in the journal and use by other researchers
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
Allowed for use for retrospective analyses or other purposes that contribute to the production of knowledge.
From where data/document is obtainable
Contact information: The email address of the corresponding author or the first author of the article.
What processes are involved for a request to access data/document
After the article is published, new researchers can send their application via their academic email, describing the research objectives and how the research will be conducted, and within 2 weeks after verification, the data will be sent via email.