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The effect of the EMD protocol for urge compared to care as usual on dermatology-specific quality of life

The effect of the EMD protocol for urge compared to care as usual on dermatology-specific quality of life - EMD-U vs CAU

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56030
Enrollment
96
Registered
2023-08-16
Start date
2024-03-11
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prurigo nodularis (nodular prurigo)

Interventions

&nbsp
EMD-U:&nbsp
The EMD protocol for urge has recently been developed and applied and clinical&nbsp
results so far have been positive [11, 14]. Working-memory theory offers an&nbsp
explanation for how EMDR might work [15, 16]. The theory states that the&nbsp
short-term or working memory can perform various tasks at the same time.&nbsp
However, the working memory has a limited attention capacity. As a result, by&nbsp
performing one task, performance on another task comes under pressure. In&nbsp
EMD-U, the patient is asked to focus on the distracting stimulus, but at the&nbsp
same time also to focus on the urge to scratch his/her skin. So, the attention,&nbsp
which is focused on the urge to scratch, is distracted by the eye movements.&nbsp
The hypothesis is that as a result, 'decay' (desensitization) of the urge to&nbsp
scratch takes place and the urge loses more and more of its urgency.&nbsp
EMD-U consists of two sessions of 60 minutes in the first three weeks. An&nbsp
important part of EMD-U consists of homework exercises. These homework&nbsp
exercises comprise to practice/apply the intervention as learned during the&nbsp
sessions with the therapist, in those situations wherein the urge to scratch&nbsp
their skin is present. In the text below, we will explain in more detail what&nbsp
the treatment protocol entails. Patients in this condition receive the EMD-U&nbsp
treatment in addition to the care as usual.&nbsp

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Public ContactR. Waalboer-Spuij

Erasmus MC, Universitair Medisch Centrum Rotterdam

dermaresearch@erasmusmc.nl010 704 01 10

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)