NCT06108869|Suspended

Study Stopped

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.

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

Royal College of Surgeons, Ireland ClinicalTrials.gov

Compare

1 other identifier

23-151

Study Type

interventional

Target

100

Locations

1 country

Sites

Timeline

RegisteredOct 2023

StartedJun 2022

CompletionJul 2026

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

2mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

Study Progress96%

Jun 2022Jul 2026

Study Start

First participant enrolled

June 1, 2022

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed

15 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected

Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

3.8 years

First QC Date

October 16, 2023

Last Update Submit

October 25, 2023

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (2)

Identify Psychosocial Baseline of CSU patents attending Urticaria clinics
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).
21 months from month 8
Assess change in psychosocial measures of participants after completing an online 6 week ABT programme
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.
21 months from month 8