Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)

October 25, 2023 updated by: Royal College of Surgeons, Ireland

This study aims to investigate the influence of psychosocial factors on Chronic Spontaneous Urticaria (CSU). Preliminary research suggests a potential link between stress and the experience of CSU symptoms. In light of these findings, our study offers a stress management intervention for individuals diagnosed with CSU.

The intervention consists of a 6-week online course designed to cultivate effective stress management techniques, referred to as 'attention-based training (ABT).' The course asks each participant to develop their own ABT practice, along with a one-hour session per week, providing techniques that participants can use to combat stressors related to their condition.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Chronic Spontaneous Urticaria (CSU) is a common disorder that is poorly understood and frequently misdiagnosed. The burden of the disease can include stress, anxiety, sleep disturbances, and difficulty with activities of daily living. Furthermore, psychological difficulties such as stress, may also aggravate the symptomatic burden of CSU. Holistic interventions are used as a complementary approach to alleviate symptoms in chronic diseases and may represent a valuable non-pharmacological approach in CSU. In 2021, Dr Padraic Dunne and colleagues published a feasibility assessment of an 8 week attention-based training programme to aid in the management of CSU [1]. Whilst this trial was deemed feasible and valuable for participants involved, further research was required with a wider sample to determine the role ABT may have in the management of the condition.

List of Aims and Objectives This current research aims to expand on their pilot study, and provide an evidence based non-pharmacological intervention to aid those in their management of CSU. This project will be the one of the first to provide CSU patients with a psychological intervention in conjunction with their clinical treatment. We believe that a combination of non-pharmacological and pharmacological solutions will ease the suffering caused by this condition and reduce the physical and fiscal burden on the Irish Health service and related clinics.

This study will 1.) Aim to identify the current psychosocial baseline of CSU patients attending urticarial clinics in Ireland and Scotland, to further highlight the psychosocial experience of this population. 2.) Provide and assess the effectiveness of an 6 week ABT programme for CSU management and patient wellbeing.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • St James's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have diagnosis of CSU

Exclusion Criteria:

  • Classified as a vulnerable adult Cannot communicate online, in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
6 Week ABT intervention as described.
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Experimental: 2
6 Week ABT intervention as described.
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Experimental: 3
6 Week ABT intervention as described.
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Experimental: 4
6 Week ABT intervention as described.
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Experimental: 5
6 Week ABT intervention as described.
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Active Comparator: 6
Delayed intervention group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Active Comparator: 7
Delayed intervention group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Active Comparator: 8
Delayed intervention group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Active Comparator: 9
Delayed intervention group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Active Comparator: 10
Delayed intervention group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Experimental: 11
ABT intervention as described
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Experimental: 12
ABT intervention as described
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Experimental: 13
ABT intervention as described
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Experimental: 14
ABT intervention as described
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Experimental: 15
ABT intervention as described
Other: ABT Online Programme

When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:

  • A short ABT practice
  • An educational component related to the development of our ABT practice
  • A group discussion on the week's topic and how it relates to you and your diagnosis
Active Comparator: 16
Delayed Control group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Active Comparator: 17
Delayed Control group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Active Comparator: 18
Delayed Control group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Active Comparator: 19
Delayed Control group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
Active Comparator: 20
Delayed Control group
Other: Delayed Control group
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify Psychosocial Baseline of CSU patents attending Urticaria clinics
Time Frame: 21 months from month 8
Identify the incidence of abnormal stress/wellbeing scores of CSU patients attending urticarial clinics in Ireland and Scotland, using a baseline questionnaire made up of the Short Stress Overload Scale (10 questions), Five Facet Mindfulness Questionnaire (FFMQ) (39 questions), PERMA Profiler for wellbeing (23 questions), The Urticaria Control Test (4 questions) and Dermatology Life Quality Index (10 questions).
21 months from month 8
Assess change in psychosocial measures of participants after completing an online 6 week ABT programme
Time Frame: 21 months from month 8
A psychosocial questionnaire made up of the Short Stress Overload Scale (10 questions), Five Facet Mindfulness Questionnaire (FFMQ) (39 questions), PERMA Profiler for wellbeing (23 questions), The Urticaria Control Test (4 questions) and Dermatology Life Quality Index (10 questions) will be provided to patients pre and post participation in the 6 week online ABT intervention.
21 months from month 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Investigators

  • Principal Investigator: Niall Conlon, PhD, St. James's Hospital, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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