nodular prurigo. Prurigo nodularis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age 18 >= - A confirmed diagnosis of PN - Stable disease activity - Suffering from persistent and frequent scratching behaviour, no successful response to care as usual - Sufficiently motivated to take part in a new intervention aimed at behaviour change
Exclusion criteria
Exclusion criteria: - Insufficient understanding of Dutch language - Severe psychiatric disorders that require treatment first, such as delusional disorder or major depression - 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 daily measure is the frequency and duration of scratching behaviour. These daily registrations are administered via the mobile phone of participants. They will take 2 minutes daily at maximum to fill out. Scratching duration is categorized in 5 intervals: 4min. | — |
Secondary
| Measure | Time frame |
|---|---|
| Every evening, patient are administered a short questionnaire containing a Likert scale wherein patients rate the amount of itch and the severity of the scratching that day on a scale from 0 to 10. Moreover, secondary outcomes are several common used questionnaires about disease activity; quality of life, self-control, and sleep quality. All standardized measures are administered at two time points: at baseline (T0) and after the end of the treatment phase (T1), that is the end of the study . The standardized measures used are: Disease activity, measures to be filled out by dermatologist or dermatology resident: The Investigator Global Assessment (IGA) is a tool for the objective assessment of chronic prurigo. The IGA for stage of chronic nodular prurigo (CNPG) and signs of activity in chronic prurigo are used. Both stage and activity are scored on a scale from 0 (clear) to 4 (severe) [24]. Two Quality of Life measures, to be filled out by the patient: 1) 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-point Likert scale. The instrument has two subscales: psychosocial impact and impact of symptoms [25]; 2) The EQ-5D-5L 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 [26]. Self-Control, measures to be filled out by the patient: The Self-Control Cognition Questionnaire, Dutch: Zelfcontrole Cognitie Vragenlijst (ZCCL). The ZCCL is an 11-item self-report questionnaire measuring perceived self-control . There are two subscales: *positive reward* (of the unwanted behaviour) and *difficulty resistin | — |
Countries
Netherlands