Meditation in Inflammatory Dermatosis (MediDermIn)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Atopic Dermatitis; Psoriasis; Pruritus

Treatments: Other: MBSR (Mindfulness-Based Stress Reduction)

Study type: Interventional

Funder types: Other

Identifiers

NCT05500794

APHP211191

Details and patient eligibility

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

MBSR (Mindfulness-Based Stress Reduction) group

Experimental group

Description:

MBSR (Mindfulness-Based Stress reduction) program : 1 weekly session of 2 hours and a half for 8 weeks, (first and last session: 3 hours) and an optional day of intensive practice of 6 hours, supervised by an MBSR instructor.

Treatment:

Other: MBSR (Mindfulness-Based Stress Reduction)

Standard group

No Intervention group

Description:

No intervention in this group which will be followed according to the standard care