Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT06108869
Status:
SUSPENDED
Last Update Posted:
2023-10-31
First Post:
2023-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single groups will be taken through the ABT programme, or the delayed control intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'Recruitment has been suspended, as we realised the university still had to finish a contract to provide insurance for myself. Therefore, the recruitment was stopped until this is secured.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify Psychosocial Baseline of CSU patents attending Urticaria clinics', 'timeFrame': '21 months from month 8', 'description': '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).'}, {'measure': 'Assess change in psychosocial measures of participants after completing an online 6 week ABT programme', 'timeFrame': '21 months from month 8', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Spontaneous Urticaria']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00841-z', 'label': '1\\. Feasibility assessment of an 8-week attention-based training programme in the management of chronic spontaneous urticaria'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': '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.\n\nList 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have diagnosis of CSU\n\nExclusion Criteria:\n\n* Classified as a vulnerable adult Cannot communicate online, in English'}, 'identificationModule': {'nctId': 'NCT06108869', 'briefTitle': 'Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Surgeons, Ireland'}, 'officialTitle': 'Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)', 'orgStudyIdInfo': {'id': '23-151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '6 Week ABT intervention as described.', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '6 Week ABT intervention as described.', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '6 Week ABT intervention as described.', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '6 Week ABT intervention as described.', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': '6 Week ABT intervention as described.', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6', 'description': 'Delayed intervention group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7', 'description': 'Delayed intervention group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '8', 'description': 'Delayed intervention group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '9', 'description': 'Delayed intervention group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10', 'description': 'Delayed intervention group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'EXPERIMENTAL', 'label': '11', 'description': 'ABT intervention as described', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'EXPERIMENTAL', 'label': '12', 'description': 'ABT intervention as described', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'EXPERIMENTAL', 'label': '13', 'description': 'ABT intervention as described', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'EXPERIMENTAL', 'label': '14', 'description': 'ABT intervention as described', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'EXPERIMENTAL', 'label': '15', 'description': 'ABT intervention as described', 'interventionNames': ['Other: ABT Online Programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': '16', 'description': 'Delayed Control group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '17', 'description': 'Delayed Control group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '18', 'description': 'Delayed Control group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '19', 'description': 'Delayed Control group', 'interventionNames': ['Other: Delayed Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '20', 'description': 'Delayed Control group', 'interventionNames': ['Other: Delayed Control group']}], 'interventions': [{'name': 'ABT Online Programme', 'type': 'OTHER', 'description': "When the study begins, participants meet each week on Microsoft teams for a 6 week period. Each session will last approximately 1 hour. There will be a maximum of six other participants and two facilitators present at each session. Each session will consist of:\n\n* A short ABT practice\n* An educational component related to the development of our ABT practice\n* A group discussion on the week's topic and how it relates to you and your diagnosis", 'armGroupLabels': ['1', '11', '12', '13', '14', '15', '2', '3', '4', '5']}, {'name': 'Delayed Control group', 'type': 'OTHER', 'description': 'Participants will still meet as a group for first two weeks, before beginning with the ABT practice.', 'armGroupLabels': ['10', '16', '17', '18', '19', '20', '6', '7', '8', '9']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'country': 'Ireland', 'facility': "St James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Niall Conlon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. James's Hospital, Ireland"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}