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
Study website
Contact information
Type
Scientific
Contact name
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/CTIS number
Nil known
IRAS number
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(s)
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
Study setting(s)
Hospital
Study 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
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 study start date
01/09/2017
Overall study 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(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
30
Total final enrolment
12
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
Study 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
ROR
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.
Intention to publish date
31/12/2020
Individual participant data (IPD) sharing plan
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.0 | 07/11/2017 | 08/10/2020 | No | Yes |
| Results article | 03/05/2021 | 13/08/2021 | Yes | No |
Additional files
- ISRCTN13672947_PIS_V1.0_07Nov17.pdf Uploaded 08/10/2020