Atopic DermatitisEMD-U vs CAUNCT06427122
Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life
A study testing EMD Protocol for Urge and Care as Usual in people with Atopic Dermatitis and Prurigo Nodularis, run by Tamar Nijsten at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Prurigo Nodularis
- What is being tested?
- EMD Protocol for Urge and Care as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Mar 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life
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.
Read the 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
- Being tested
- EMD Protocol for Urge, Care as Usual
- Keywords
- EMD Protocol for Urge, Quality of Life, Itch, Scratching
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMD Protocol for UrgeBehavioural
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 UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
This is a validated scoring system that grades the physical signs of atopic dermatitis/eczema.
The minimum EASI score is 0 and the maximum EASI score is 72. Higher scores indicate higher disease activity.
Measured: 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)
The IGA is a 5-point tool for the objective assessment of chronic prurigo. The IGA for stage of chronic nodular prurigo (CNPG) and signs of activity in chronic prurigo are used. Items range from 0 (clear) to 4 (severe). Higher scores indicate higher disease activity.
Measured: 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
It is a generic instrument that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale.
Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The visual analogue scale (VAS), on which the patient rates his/her perceived health, ranges from 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: 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)
The ZCCL is an 11-item self-report questionnaire measuring perceived self-control. There are two subscales: 'positive reward' (of the unwanted behaviour) and 'difficulty resisting'. Each item is scored on a 5-point Likert scale, ranging from 1 (not applicable at all) to 5 (totally applicable). Total score ranges from 11-55. Higher scores indicate less self-control.
Measured: 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)
The PHQ-4 is a brief self-report screening tool for depression and anxiety, consisting of four items. Two items on depression, and two items on anxiety are scored with a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Higher scores indicate more depression and anxiety symptoms.
Measured: 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).
Skin Picking Scale (SPS)
a six-item self-report measure for the assessment of skin picking behaviour. The scale has a total score range of 0-24. Higher scores indicate more skin picking.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start11 Mar 2024
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control).
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamar Nijsten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tamar Nijsten, Erasmus Medical Center
- Investigators
- Rick Waalboer-Spuij, MD, PhD, Principal investigator, Erasmus University Medical Center, Department of DermatologyLeonieke W Kranenburg, PhD, Principal investigator, Erasmus University Medical Center, Department of Psychiatry, Section Medical Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427122
- Sponsor's protocol ID
- 11074
- Other IDs
- NL84417.078.23
- Acronym
- EMD-U vs CAU
- Status last verified
- Nov 2025
- First submitted
- 7 Feb 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD is shared due to privacy issues
Publications
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.
PubMed 37081840
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life
- ClinicalTrials.gov ID
- NCT06427122
- Acronym / sponsor ID
- EMD-U vs CAU / 11074
- Conditions
- Atopic Dermatitis, Prurigo Nodularis
- Keywords
- EMD Protocol for Urge, Quality of Life, Itch, Scratching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tamar NijstenUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control).
| Arm | Type | Receives |
|---|---|---|
| EMD-U | Experimental | Behavioral: EMD Protocol for Urge, Other: Care as UsualThe 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. |
| Care as Usual | Active comparator | Other: Care as UsualPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMD Protocol for UrgeDuring 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. | Behavioural | EMD-U |
| Care as UsualPatients 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, EMD-U |
Primary outcome
Skindex-29
Time frame: 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 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.
6 secondary outcomes
Eczema Area and Severity Index (EASI)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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).
Skin Picking Scale (SPS)
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 37081840de 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.
- Individual participant dataSharing planned: No. No IPD is shared due to privacy issues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Waalboer-Spuij, MD, PhD principal investigator
Erasmus University Medical Center, Department of Dermatology
Leonieke W Kranenburg, PhD principal investigator
Erasmus University Medical Center, Department of Psychiatry, Section Medical Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMD Protocol for Urge and Care as Usual in people with Atopic Dermatitis and Prurigo Nodularis, run by Tamar Nijsten at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skindex-29 (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.