The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Skindex-29
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Skindex-29
时间窗: 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.
次要结局
- 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).)
- 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).)
- 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).)
- Skin Picking Scale (SPS)(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).)
研究者
Tamar Nijsten
Prof.
Erasmus Medical Center