Chronic Spontaneous UrticariaNCT06108869
Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)
A study testing ABT Online Programme in people with Chronic Spontaneous Urticaria, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- ABT Online Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jun 2022to 1 Jul 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have diagnosis of CSU
Who cannot join
- Classified as a vulnerable adult Cannot communicate online, in English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- ABT Online Programme, Delayed Control group
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT Online ProgrammeOther
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
Delayed Control groupOther
Participants will still meet as a group for first two weeks, before beginning with the ABT practice.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6 Week ABT intervention as described. Receives: Other: ABT Online Programme |
| 2 | Experimental | 6 Week ABT intervention as described. Receives: Other: ABT Online Programme |
| 3 | Experimental | 6 Week ABT intervention as described. Receives: Other: ABT Online Programme |
| 4 | Experimental | 6 Week ABT intervention as described. Receives: Other: ABT Online Programme |
| 5 | Experimental | 6 Week ABT intervention as described. Receives: Other: ABT Online Programme |
| 6 | Active comparator | Delayed intervention group Receives: Other: Delayed Control group |
| 7 | Active comparator | Delayed intervention group Receives: Other: Delayed Control group |
| 8 | Active comparator | Delayed intervention group Receives: Other: Delayed Control group |
| 9 | Active comparator | Delayed intervention group Receives: Other: Delayed Control group |
| 10 | Active comparator | Delayed intervention group Receives: Other: Delayed Control group |
| 11 | Experimental | ABT intervention as described Receives: Other: ABT Online Programme |
| 12 | Experimental | ABT intervention as described Receives: Other: ABT Online Programme |
| 13 | Experimental | ABT intervention as described Receives: Other: ABT Online Programme |
| 14 | Experimental | ABT intervention as described Receives: Other: ABT Online Programme |
| 15 | Experimental | ABT intervention as described Receives: Other: ABT Online Programme |
| 16 | Active comparator | Delayed Control group Receives: Other: Delayed Control group |
| 17 | Active comparator | Delayed Control group Receives: Other: Delayed Control group |
| 18 | Active comparator | Delayed Control group Receives: Other: Delayed Control group |
| 19 | Active comparator | Delayed Control group Receives: Other: Delayed Control group |
| 20 | Active comparator | Delayed Control group Receives: Other: Delayed Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Psychosocial Baseline of CSU patents attending Urticaria clinics
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).
Measured: 21 months from month 8
Assess change in psychosocial measures of participants after completing an online 6 week ABT programme
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.
Measured: 21 months from month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jun 2022
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Why it stopped: Recruitment has been suspended, as we realised the university still had to finish a contract to provide insurance for myself. Therefore, the recruitment was stopped until this is secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single groups will be taken through the ABT programme, or the delayed control intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niall Conlon, PhD, Principal investigator, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108869
- Sponsor's protocol ID
- 23-151
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)
- ClinicalTrials.gov ID
- NCT06108869
- Acronym / sponsor ID
- 23-151
- Conditions
- Chronic Spontaneous Urticaria
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment has been suspended, as we realised the university still had to finish a contract to provide insurance for myself. Therefore, the recruitment was stopped until this is secured.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 20
- Model description
- Single groups will be taken through the ABT programme, or the delayed control intervention
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: ABT Online Programme6 Week ABT intervention as described. |
| 2 | Experimental | Other: ABT Online Programme6 Week ABT intervention as described. |
| 3 | Experimental | Other: ABT Online Programme6 Week ABT intervention as described. |
| 4 | Experimental | Other: ABT Online Programme6 Week ABT intervention as described. |
| 5 | Experimental | Other: ABT Online Programme6 Week ABT intervention as described. |
| 6 | Active comparator | Other: Delayed Control groupDelayed intervention group |
| 7 | Active comparator | Other: Delayed Control groupDelayed intervention group |
| 8 | Active comparator | Other: Delayed Control groupDelayed intervention group |
| 9 | Active comparator | Other: Delayed Control groupDelayed intervention group |
| 10 | Active comparator | Other: Delayed Control groupDelayed intervention group |
| 11 | Experimental | Other: ABT Online ProgrammeABT intervention as described |
| 12 | Experimental | Other: ABT Online ProgrammeABT intervention as described |
| 13 | Experimental | Other: ABT Online ProgrammeABT intervention as described |
| 14 | Experimental | Other: ABT Online ProgrammeABT intervention as described |
| 15 | Experimental | Other: ABT Online ProgrammeABT intervention as described |
| 16 | Active comparator | Other: Delayed Control groupDelayed Control group |
| 17 | Active comparator | Other: Delayed Control groupDelayed Control group |
| 18 | Active comparator | Other: Delayed Control groupDelayed Control group |
| 19 | Active comparator | Other: Delayed Control groupDelayed Control group |
| 20 | Active comparator | Other: Delayed Control groupDelayed Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have diagnosis of CSU
Key exclusion criteria (1 listed)
- Classified as a vulnerable adult Cannot communicate online, in English
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 |
|---|---|---|
| ABT Online ProgrammeWhen 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 | Other | 1, 11, 12, 13, 14, 15, 2, 3, 4, 5 |
| Delayed Control groupParticipants will still meet as a group for first two weeks, before beginning with the ABT practice. | Other | 10, 16, 17, 18, 19, 20, 6, 7, 8, 9 |
Primary outcome
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- 1\. Feasibility assessment of an 8-week attention-based training programme in the management of chronic spontaneous urticariaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Niall Conlon, PhD principal investigator
St. James's Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABT Online Programme in people with Chronic Spontaneous Urticaria, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 1 inclusion and 1 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: paused, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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. 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?
Results are not available in the source record.
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?
Identify Psychosocial Baseline of CSU patents attending Urticaria clinics (time frame: 21 months from month 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2023.