Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427122
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-02-07
Brief Title:
Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life
Sponsor:
Tamar Nijsten
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMD-U vs CAU
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8441707823 | OTHER | ToetsingOnline | None |