Improving quality of life for patients with severe itching from skin conditions
The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life
This study is testing a new treatment to see if it can help people with severe itching from skin conditions like atopic dermatitis or prurigo nodularis feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06427122 on ClinicalTrials.gov |
What this trial studies
This open randomized controlled trial aims to evaluate the effectiveness of the EMD protocol for urge (EMD-U) in enhancing dermatology-specific quality of life for patients suffering from atopic dermatitis or prurigo nodularis with severe scratching behavior. Participants will be randomly assigned to receive either the EMD-U intervention or care as usual (CAU), with assessments conducted at multiple time points over six months. The EMD-U treatment combines techniques from Eye Movement Desensitization and Reprocessing therapy, Cognitive Behavioral Therapy, and hypnotherapy to help reduce the urge to scratch. The primary outcome will be measured using the Skindex-29 symptoms scale to determine the difference in treatment effects between the two groups.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of atopic dermatitis or prurigo nodularis who experience persistent and frequent scratching behavior.
Not a fit: Patients with severe psychiatric disorders requiring immediate treatment or those who do not understand the Dutch language may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from severe itching associated with skin conditions.
How similar studies have performed: While the EMD-U approach is relatively novel, preliminary results have shown promise in reducing scratching behavior in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rotterdam
- Erasmus University Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Rick Waalboer-Spuij, MD, PhD — Erasmus University Medical Center, Department of Dermatology
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.