Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life

Last updated: May 21, 2024
Sponsor: Tamar Nijsten
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atopic Dermatitis

Eczema (Atopic Dermatitis)

Warts

Treatment

Care as Usual

EMD Protocol for Urge

Clinical Study ID

NCT06427122
11074
NL84417.078.23
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 medicationchange, etc.)

  • Sufficiently motivated to take part in a new intervention aimed at behaviour change

Exclusion

Exclusion Criteria:

  • Insufficient understanding of Dutch language

  • Severe psychiatric disorders that require treatment first, such as delusionaldisorder or major depression

  • If medication is changed during the course of the study, the participant will beconsidered a drop-out from the moment the medication has changed.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Care as Usual
Phase:
Study Start date:
March 11, 2024
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Erasmus University Medical Center

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

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