Actively Recruiting

Phase Not Applicable
Age: 18Days +
All Genders
NCT05500794

Meditation in Inflammatory Dermatosis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-09-19

72

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Meditation in Inflammatory Dermatosis

Who Can Participate

Age: 18Days +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 years old or older
  • Has health insurance coverage
  • Significant itching defined by Visual Analog Scale pruritus score of 4 or higher
  • Patient with plaque psoriasis without joint involvement and mild to moderate severity (PASI >10) with Dermatology Life Quality Index (DLQI) above 10
  • Or patient with atopic dermatitis with mild to moderate severity (SCORAD >10) and DLQI above 10
  • Diagnosis according to Hanifin and Rajka criteria for atopic dermatitis
  • Patient in a stable psychological state
  • Speaks French language
Not Eligible

You will not qualify if you...

  • Currently receiving systemic treatment or stopped systemic treatment within the last month
  • Diagnosed psychiatric illnesses including psychotic disorder, severe anxiety disorder, severe depressive episode, or bipolar disorder with current depressive or manic episode
  • Taking psychotropic or neuroleptic medications
  • Participating in another interventional research study or within exclusion period after previous study
  • Patient under AME (State Medical Aid)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Saint-Louis

Paris, France, 75010

Actively Recruiting

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Research Team

C

Charles CASSIUS, Dr

CONTACT

J

Jérôme Lambert, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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