跳至主要内容
临床试验/NCT05500794
NCT05500794招募中不适用

Evaluation of the Therapeutic Efficacy of a Mindfulness-Based Stress Reduction (MBSR) Program as an Adjuvant Therapy in Patients With Moderate Pruritic Inflammatory Dermatosis (Psoriasis or Atopic Dermatitis)

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
Pruritus assessed by Visual Analogue Scale (VAS)

研究概览

简要总结

Psoriasis and atopic dermatitis are multifactorial inflammatory dermatoses, with a very high prevalence, reaching more than 120 million patients in the world. Although the physiopathological mechanisms are not yet clearly defined, these inflammatory dermatoses involve an interaction between the immune system and the epidermal cells, severe skin inflammation and often very intense pruritus. The objectives of an effective management should be to treat lesions in order to reduce them, but also to reduce itching and allow the patients to accept and cope with their pathology, without neglecting an improvement in the "Dermatology Life Quality Index" (DLQI) and in the psychological state, sometimes depressive, of the patient. Itching is defined as "a feeling that needs to be scratched urgently" and can cause significant distress along with pain. It severely impacts the quality of life and the quality of sleep. Chronic itching is associated with increased stress, anxiety, and other mood disorders. In turn, stress and anxiety exacerbate the itching, leading to a vicious cycle of pruritus - scratching that affects patient behavior (excessive scratching) and worsens disease prognosis and quality of life. Much research over the past few decades has demonstrated the effect of mindfulness meditation on emotional and cognitive responsiveness, cognitive flexibility, rumination, self-compassion and mindfulness, but also on acute pain, anxiety, stress, depression, cardiovascular disease, eating disorders, cancer and cognitive loss with age. Several studies have shown the impact of mindfulness on brain function and immunity, with evidence for the association between mindfulness and changes in the levels of markers characteristic of immune system activity and inflammation, known to be increased in psoriasis or atopic dermatitis. The objective is to evaluate the effect of mental training in the regulation of stress and emotions through mindfulness meditation in patients with moderate, itchy atopic dermatitis or psoriasis, not treated with systemic agents (e.g.: biotherapies). This project is based on the premise that mental training in the regulation of stress and emotions through meditation would reduce the effects of the infernal itch-scratch cycle, alleviating pruritus, thus improving the well-being and mental health of patients while reducing their inflammatory skin lesions and limiting the appearance of new lesions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Days 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18 years old or older
  • With health insurance coverage
  • Significant pruritus defined by a Visual Analogical Scale (VAS) pruritus ≥ 4
  • Patient with plaque psoriasis
  • Without joint involvement
  • Mild to moderate severity (PASI>10)
  • DLQI > 10
  • OR Patient with atopic dermatitis:
  • Mild to moderate severity (SCORAD>10)
  • DLQI > 10
  • Diagnosis according to Hanifin and Raijka criteria
  • Patient in a stable psychological state
  • French langage spoken
  • Exclusion Criteria :
  • Current systemic treatment or treatment discontinued within the last month
  • Psychiatric illnesses diagnosed according to the DSM-5 or ICD-10 international criteria of psychotic disorder, severe anxiety disorder, depressive disorder with a current depressive episode of severe intensity, bipolar disorder with a current depressive or manic episode
  • Taking psychotropic or neuroleptic treatments
  • Participation in another interventional research study or being in the exclusion period at the end of a previous study, if applicable
  • Patient under AME

排除标准

  • 未提供

结局指标

主要结局

Pruritus assessed by Visual Analogue Scale (VAS)

时间窗: at 8 weeks

VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.

次要结局

  • Number of scratches per day (including nights)(at 16 weeks as compared to 8 weeks)
  • SCORAD Index for atopic dermatitis(at 16 weeks as compared to 8 weeks)
  • Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)(at 16 weeks as compared to 8 weeks)
  • Psorasis Area and severity index (PASI Index) for psoriasis group(at 16 weeks as compared to 8 weeks)
  • Pruritus assessed by Visual Analogue Scale (VAS)(at 16 weeks)
  • Number of dermatocorticoides tubes(at 16 weeks as compared to 8 weeks)
  • Stress evaluation assessed by Perceived Stress Scale(at 16 weeks as compared to 8 weeks)
  • Quantification of inflammatory stress markers in saliva(at 16 weeks as compared to 8 weeks)
  • Quantification of inflammatory stress markers in serum(at 16 weeks as compared to 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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