Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life (EMD-U vs CAU)

Tamar Nijsten

Status: Enrolling

Conditions: Atopic Dermatitis; Prurigo Nodularis

Treatments: Behavioral: EMD Protocol for Urge; Other: Care as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06427122

NL84417.078.23 (Other Identifier)

11074

Details and patient eligibility

About

The primary objective of this open randomised controlled trial is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour.

The main study parameter is the difference in treatment effect between EMD-U and CAU at T2, measured with the Skindex-29 symptoms scale. There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months.

Patients are randomly allocated to either the EMD-U or CAU condition.

Full description

Rationale: The EMD protocol for urge (EMD-U) is a recently developed treatment that combines elements of Eye Movement Desensitization and Reprocessing (EMDR) therapy, Cognitive Behaviour therapy, and hypnotherapy. EMD-U aims to reduce the urge for scratching behaviour through desensitization techniques, self-registration of behaviour, and homework assignments. The EMD-U treatment has shown promising results in reducing scratching behaviour in patients with atopic dermatitis and is currently being investigated in patients with prurigo nodularis. Yet, the added value of the brief EMD-U intervention in addition to the care as usual (CAU) in improving dermatology-specific quality of life is unknown.

Objective: The primary objective of the study is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour.

Study design: An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control). There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months.

Study population: Patients with atopic dermatitis or prurigo nodularis who suffer from substantial scratching behaviour.

Intervention (if applicable): Patients are randomly allocated to either the EMD-U or CAU condition.

The EMD-U treatment lasts eight weeks, in which two EMD-U sessions and two phone calls take place in the first three weeks. After the first EMD-U session, patients are instructed to apply the learned technique at home until the end of the study. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

EMD-U

Experimental group

Description:

The EMD-U treatment lasts eight weeks, in which two EMD-U sessions of 60 minutes and two phone calls take place in the first three weeks. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home. An important part of EMD-U consists of homework exercises. These homework exercises comprise to practice/apply the intervention as learned during the sessions with the therapist, in those situations wherein the urge to scratch their skin is present. In the text below, we will explain in more detail what the treatment protocol entails. Patients in this condition receive the EMD-U treatment in addition to the care as usual.

Treatment:

Behavioral: EMD Protocol for Urge

Other: Care as Usual

Care as Usual

Active Comparator group

Description:

Patients in the control group receive care as usual (CAU), which is the standard care of the dermatologist. In addition to completing the questionnaires at T0, 1, 2, 3, and 4 these patients are not offered any additional treatment or support aimed at their scratching behaviour.

Treatment:

Other: Care as Usual