Clinical trial NCT06108869: Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)
Official title: Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single groups will be taken through the ABT programme, or the delayed control intervention
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Must have diagnosis of CSU

Exclusion Criteria:

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

Primary outcomes:
measure: Identify Psychosocial Baseline of CSU patents attending Urticaria clinics
timeFrame: 21 months from month 8
measure: Assess change in psychosocial measures of participants after completing an online 6 week ABT programme
timeFrame: 21 months from month 8
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St James's Hospital
Study officials:
affiliation: St. James's Hospital, Ireland
name: Niall Conlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: