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

NCT06427122 | Completed

• 2 other identifiers: 11074NL84417.078.23
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Prurigo Nodularis

Keywords

EMD Protocol for Urge; Quality of Life; Itch; Scratching

Outcome Measures

Primary Outcomes (1)

• Skindex-29

  The main study outcome is the dermatology-specific health-related quality of life (HRQOL). It consists of 30 items to be scored on a 5-point response scale. Outcome ranges from 0 (never) to 100 (all the time). The sum of scores is devided by the number of items answered. Higher scores indicate worse quality of life. The instrument has three subscales: symptoms, emotions, and functioning.

  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).

Secondary Outcomes (6)

• Eczema Area and Severity Index (EASI)

  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).

• Investigator Global Assessment (IGA)

  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).

• EQ-5D-5L

  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 Self-Control Cognition Questionnaire, Dutch: Zelfcontrole Cognitie Vragenlijst (ZCCL)

  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).

• Patient Health Questionnaire for anxiety and depression (PHQ-4)

  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).

Other Outcomes (4)

• Life Events Checklist for DSM-5 (LEC-5)

  At start of study (T0)

• Treatment Expectation Questionnaire (TEX-Q)

  At start of study (T0)

• Mental imagery

  At start of study (T0)

Study Arms (2)

EMD-U

EXPERIMENTAL

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.

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

Care as Usual

ACTIVE COMPARATOR

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.

Other: Care as Usual

Interventions

EMD Protocol for Urge 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.

EMD-U

Care as Usual 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; EMD-U

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tamar Nijsten: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37081840 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rick Waalboer-Spuij, MD, PhD

  Erasmus University Medical Center, Department of Dermatology

  PRINCIPAL INVESTIGATOR

• Leonieke W Kranenburg, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control).

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: May 23, 2024
• Study Start: March 11, 2024
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)