Clinical trial NCT06427122: Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life
Official title: The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Prurigo Nodularis
Keywords: EMD Protocol for Urge
Quality of Life
Itch
Scratching
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Skindex-29
timeFrame: 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:
measure: Eczema Area and Severity Index (EASI)
timeFrame: 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).
measure: Investigator Global Assessment (IGA)
timeFrame: 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).
measure: EQ-5D-5L
timeFrame: 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).
measure: The Self-Control Cognition Questionnaire, Dutch: Zelfcontrole Cognitie Vragenlijst (ZCCL)
timeFrame: 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).
measure: Patient Health Questionnaire for anxiety and depression (PHQ-4)
timeFrame: 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).
measure: Skin Picking Scale (SPS)
timeFrame: 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:
measure: Life Events Checklist for DSM-5 (LEC-5)
timeFrame: At start of study (T0)
measure: Treatment Expectation Questionnaire (TEX-Q)
timeFrame: At start of study (T0)
measure: Mental imagery
timeFrame: At start of study (T0)
measure: Visits
timeFrame: Six months after start study (T4)
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Erasmus University Medical Center, Department of Dermatology
name: Rick Waalboer-Spuij, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus University Medical Center, Department of Psychiatry, Section Medical Psychology
name: Leonieke W Kranenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.