Condition category
Skin and Connective Tissue Diseases
Date applied
09/09/2020
Date assigned
22/09/2020
Last edited
08/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Urticaria and angioedema are terms used to describe hives and swellings, which can be very distressing, recurrent and sometimes difficult to treat. While the exact cause of this condition is not known, it is known that a specialised cell called the ‘mast cell’ is important. Mast cells can be affected by many factors, one of which might be chemical signals released when the body is under stress. These signals might make the condition worse. It has been suggested that by controlling how the body responds to stress, mast cell activity and therefore hives and swelling can be limited. There is growing evidence to support the potential benefits of attention based training (ABT) on psychological and physiological wellbeing. Therefore, the aim of this study is to find out whether ABT could help to improve the wellbeing of urticaria patients attending St James’s’ hospital. Based on the results of the study, the researchers hope to develop an ABT programme that can be used to help reduce stress and improve wellbeing among urticaria patients throughout Ireland.

Who can participate?
Patients aged over 18 with chronic spontaneous urticaria that is poorly controlled

What does the study involve?
The study involves a preliminary appointment with a researcher where participants fill out questionnaires and have a blood sample taken. They will then attend eight sessions of attention based training. These sessions aim to teach skills in meditation. It is hoped that these skills might improve symptoms of urticaria. Participants then attend a follow-up appointment with a researcher where they again complete questionnaires and have a blood sample taken.

What are the possible benefits and risks of participating?
The researchers do not anticipate any risks from taking part. There will be no direct benefit from taking part although it is hoped that participants might find the skills taught in the programme useful and informative.

Where is the study run from?
St James's Hospital (Ireland)

When is the study starting and how long is it expected to run for?
September 2017 to January 2022

Who is funding the study?
St James's Hospital (Ireland)

Who is the main contact?
Dr Katie Ridge
kridge@stjames.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katie Ridge

ORCID ID

https://orcid.org/0000-0003-4276-7050

Contact details

Immunology Department
St James’s Hospital
Dublin
D08X 4RX
Ireland
+353 (0)851814611
kridge@stjames.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Attention-based training programme in the management of chronic spontaneous urticaria and angioedema

Acronym

ABT in the management of CSUA

Study hypothesis

It is hypothesised that an attention-based training programme based on meditation will reduce individual perceived symptoms in patients with chronic spontaneous urticaria and angioedema.

Ethics approval

Approved 12/01/2018, SJH/AMNCH Research Ethics Committee Secretariat (Tallaght University Hospital/St James’s Hospital Joint Research Ethics Committee, Tallaght University Hospital, Tallaght, Dublin 24, D24 NR0A, Ireland; +353 (0)1 414 2199; ResearchEthics@tuh.ie/ Sadhbh.ONeill@tuh.ie), REC ref: 2019-11 List 41 (8), Previous REC Ref: 2018-01 Chairman’s Action (5)

Study design

Prospective single-arm single-site study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Chronic spontaneous urticaria and angioedema

Intervention

This study has one arm, which is attendance at an attention-based training programme based on meditation for patients with chronic spontaneous urticaria. The attention-based training programme consists of 8 x 90-minute sessions that are delivered by a qualified psychologist.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Barriers to implementation of the intervention identified through convergent interviewing techniques at baseline and 1-week post completion of the intervention
2. Recruitment and retention of participants measured by recording participant attendance throughout the intervention over an 8-week period
3. Adherence to daily practice using individual biofeedback tools (HeartMath software) throughout the intervention over an 8- week period
4. Feasibility of collecting outcome assessment data measured by assessing the return of data from participants at baseline and 1-week post completion of the intervention
5. Qualitative assessment of participant experiences of the programme collected via interview 1-week post completion of the intervention

Secondary outcome measures

1. Perceived individual symptoms measured using the urticaria control test (UCT) at baseline, 1 week before and 1 week after completion of the ABT programme
2. Depression, anxiety and stress measured using the depression-anxiety-stress score (DASS) at baseline and post 8-week ABT programme
3. Bio-psycho-social health measured using the PERMA-profiler at baseline, 1 week before and 1 week after completion of the ABT programme
4. Traits associated with sustained meditation practice (attention, observational skills, non-reactivity and non-judgemental skills) measured using the five-facet mindfulness questionnaire (FFMQ) at baseline, 1 week before and 1 week after completion of the ABT programme

Overall trial start date

01/09/2017

Overall trial end date

01/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults with a clinical diagnosis of chronic spontaneous urticaria (CSU) with or without angioedema
2. Symptoms on at least one day per week
3. Urticaria control test score of <12 indicative of poorly controlled symptoms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Patients who had started an anti-depressant medication in the past 3 months
2. Diagnosis of an Axis I mental health disorder

Recruitment start date

01/01/2020

Recruitment end date

01/01/2021

Locations

Countries of recruitment

Ireland

Trial participating centre

St. James's Hospital
James's Street
Dublin
D08 X4RX
Ireland

Sponsor information

Organisation

St. James's Hospital

Sponsor details

James's Street
Dublin 8
Dublin
D08X 4RX
Ireland
+353 (0)14103000
info@stjames.ie

Sponsor type

Hospital/treatment centre

Website

http://www.stjames.ie/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The researchers are also preparing a protocol for submission to a peer-reviewed journal.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/10/2020: The participant information sheet has been uploaded. 15/09/2020: Trial's existence confirmed by Tallaght University Hospital/St James’s Hospital Joint Research Ethics Committee.