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

Not Applicable

Suspended

• Conditions: Chronic Spontaneous Urticaria
• Interventions: Other: Delayed Control group; Other: ABT Online Programme

• Registration Number: NCT06108869
• Lead Sponsor: Royal College of Surgeons, Ireland

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.

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Primary Completion: 2026-04-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Must have diagnosis of CSU

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6	Delayed Control group	Delayed intervention group
1	ABT Online Programme	6 Week ABT intervention as described.
3	ABT Online Programme	6 Week ABT intervention as described.
4	ABT Online Programme	6 Week ABT intervention as described.
5	ABT Online Programme	6 Week ABT intervention as described.
19	Delayed Control group	Delayed Control group
2	ABT Online Programme	6 Week ABT intervention as described.
7	Delayed Control group	Delayed intervention group
10	Delayed Control group	Delayed intervention group
8	Delayed Control group	Delayed intervention group
14	ABT Online Programme	ABT intervention as described
15	ABT Online Programme	ABT intervention as described
18	Delayed Control group	Delayed Control group
9	Delayed Control group	Delayed intervention group
17	Delayed Control group	Delayed Control group
11	ABT Online Programme	ABT intervention as described
12	ABT Online Programme	ABT intervention as described
13	ABT Online Programme	ABT intervention as described
16	Delayed Control group	Delayed Control group
20	Delayed Control group	Delayed Control group

Primary Outcome Measures

Name	Time	Method
Assess change in psychosocial measures of participants after completing an online 6 week ABT programme	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.
Identify Psychosocial Baseline of CSU patents attending Urticaria clinics	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).

Trial Locations

Locations (1)

St James's Hospital; 🇮🇪 Dublin, Ireland