Chronic spontaneous urticaria and angioedema Skin and Connective Tissue Diseases Urticaria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Ireland