Prurigo nodularis (nodular prurigo)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age 18 >= - A confirmed diagnosis of atopic dermatitis or prurigo nodularis - Suffering from persistent and frequent scratching behaviour - IGA-CPG activity score >= 3 OR Skindex-29 symptoms subscale score >= 42 - Stable course of treatment in the two weeks prior to the study (no medication change, etc.) - 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 |
|---|---|
| The main study outcome is the dermatology-specific health-related quality of life (HRQOL), measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). The SKINDEX-29 is used to measure this outcome. It consists of 30 items to be scored on a 5-point response scale. The instrument has three subscales: symptoms, emotions, and functioning [17]. 17. Chren, M.-M., et al., Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Archives of dermatology, 1997. 133(11): p. 1433-1440. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are several commonly used measures for disease activity, health-related quality of life, self-control, depression and anxiety, and skin picking. All standardized measures are administered at four time points: at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). The standardized measures used are: Disease activity, measures to be filled out by dermatologist or dermatology resident: The disease activity of patients with atopic dermatitis is scored using the Eczema Area and Severity Index (EASI) [18]. This is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. For patients with prurigo nodularis and excoriation disorder, the Investigator Global Assessment (IGA) is used. The IGA is a 5-point 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 [19]. Health-related Quality of Life measure, to be filled out by the patient: 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 [20]. 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 resisting*. Each item is scored on a 5-point Likert scale [21]. Depression and anxiety, measures to be filled out by the patient: The four item Patient Health Questionnaire for | — |
Countries
Netherlands
Contacts
Erasmus MC, Universitair Medisch Centrum Rotterdam