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

R

Royal College of Surgeons, Ireland

Status

Suspended

Conditions

Chronic Spontaneous Urticaria

Treatments

Other: Delayed Control group
Other: ABT Online Programme

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Must have diagnosis of CSU

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 20 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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