atopic dermatitis eczema
Conditions
Interventions
Eye Movement and Desensitization Reprocessing (EMDR) therapy an evidence-based
psychological treatment that is recommended by national guidelines for the
treatment of PTSD (8). Since then, it has be
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18 > - A confirmed diagnosis of AD - Systemic treatment for AD with stable disease activity - Suffering from persistent scratching behavior, no successful response to care as usual - Sufficiently motivated to take part in a new intervention aimed at behavior change
Exclusion criteria
Exclusion criteria: - Insufficient understanding of Dutch language - Severe psychiatric disorders that require treatment first - If medication is changed during the course of the study, the participant will be considered a drop-out from the moment the medication has changed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within a multiple baseline design across subjects, the primary endpoints are the so called target-measures. These are frequent measures that target the behavior that is to be altered by the intervention. Within this study, daily measure is: Scratching behavior. The frequency and duration of both actual scratching and, after the start of the treatment also imaginary scratching are measured. These daily registrations are standardized and are administered automatically via the mobile phone of participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Within this study, secondary endpoints are the standardized measures. Standardized measures are administered to compare study participants to existing norm groups to see whether the intervention has resulted in clinical relevant changes. Standardized measures in this study are aimed at 1. Disease activity, 2. Quality of life and 3. Self-control. These measures are administered at three timepoints: at baseline (T0), directly after the end of the treatment phase (T1) and after the last follow-up measurement, that is, after 6 weeks (T2). Standardised measures employed in this study are: Disease activity, measures to be filled out by dermatologist, at T0 and T2 only: - Eczema Area and Severity Index (EASI). A validated scoring system that grades the physical signs of atopic dermatitis/eczema. EASI is the core outcome for measuring the clinical signs of eczema in all trials. - Investigator*s Global Assessment (IGA) scale. A 5-point tool to measure disease severity. Quality of Life, measures to be filled out by the patient at T0, T1 and T2: - Patient-Oriented Eczema Measure (POEM). The POEM is a Patient-Oriented Eczema Measure consisting of 7 items to be scored on a 4-point scale. - SKINDEX-17. The Skindex-17 is a dermatology-specific health-related quality of life (HRQOL) instrument. It consists of 17 items to be scored on a 5-pointy scale. The instrument has two subscales: psychosocial impact and impact of symptoms. - EQ-5D-5L. The EQ-5D measures health-related quality of life. It is a generic instrument that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient*s self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient*s own ju | — |
Countries
Netherlands
Outcome results
None listed