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

NCT ID: NCT06427122

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2025-09-15

Brief 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.

Detailed 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.

Conditions

Atopic Dermatitis; Prurigo Nodularis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMD-U

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.

Group Type: EXPERIMENTAL

EMD Protocol for Urge

Intervention Type: BEHAVIORAL

During the EMD-U sessions, the patient is asked to focus on the spot on his/her skin where the urge to scratch is highest. The patient is asked to rate the level of urge to scratch this spot on a 10-point scale and to imagine that they scratch this spot as they would like. At the same time eye movements are offered for 30 seconds. This procedure is repeated until the level of urge to scratch has become nihil. This procedure is repeated for all other skin parts where the patient experiences an urge to scratch, until there are no skin parts left. As a homework assignment straight after the first session, the patient is instructed and encouraged to practice the same intervention at home. The two EMD-U sessions and two phone calls, take place in the first three weeks of the study. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home.

Care as Usual

Intervention Type: OTHER

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.

Care as Usual

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.

Group Type: ACTIVE_COMPARATOR

Care as Usual

Intervention Type: OTHER

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.

Interventions

EMD Protocol for Urge

During the EMD-U sessions, the patient is asked to focus on the spot on his/her skin where the urge to scratch is highest. The patient is asked to rate the level of urge to scratch this spot on a 10-point scale and to imagine that they scratch this spot as they would like. At the same time eye movements are offered for 30 seconds. This procedure is repeated until the level of urge to scratch has become nihil. This procedure is repeated for all other skin parts where the patient experiences an urge to scratch, until there are no skin parts left. As a homework assignment straight after the first session, the patient is instructed and encouraged to practice the same intervention at home. The two EMD-U sessions and two phone calls, take place in the first three weeks of the study. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home.

Intervention Type: BEHAVIORAL

Care as Usual

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.

Intervention Type: OTHER

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tamar Nijsten

OTHER

Sponsor Role: lead

Responsible Party

Tamar Nijsten

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rick Waalboer-Spuij, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus University Medical Center, Department of Dermatology

Leonieke W Kranenburg, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus University Medical Center, Department of Psychiatry, Section Medical Psychology

Locations

Erasmus University Medical Center

Rotterdam, , Netherlands

Countries

Netherlands

References

de Veer MR, Waalboer-Spuij R, Hijnen DJ, Doeksen D, Busschbach JJ, Kranenburg LW. Reducing scratching behavior in atopic dermatitis patients using the EMDR treatment protocol for urge: A pilot study. Front Med (Lausanne). 2023 Apr 4;10:1101935. doi: 10.3389/fmed.2023.1101935. eCollection 2023.

Reference Type: BACKGROUND

PMID: 37081840 (View on PubMed)

Other Identifiers

NL84417.078.23

Identifier Type: OTHER

Identifier Source: secondary_id

11074

Identifier Type: -

Identifier Source: org_study_id