Meditation in Inflammatory Dermatosis

Official title

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)

Overview

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.

Interventions

• Other MBSR (Mindfulness-Based Stress Reduction)
  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. In each weekly session, the instructor creates a supportive environment in which: * Guided meditation practices; * Mindfulness stretching and yoga; * Reflection and group discussion periods aimed at promoting mindfulness in daily life; * Practice instructions and opportun

Primary outcome measures

• Pruritus assessed by Visual Analogue Scale (VAS) [Time frame: at 8 weeks]

Secondary outcome measures (12)

• Pruritus assessed by Visual Analogue Scale (VAS) [Time frame: at 16 weeks]
• Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ) [Time frame: at 8 weeks]
• Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ) [Time frame: at 16 weeks as compared to 8 weeks]
• Number of dermatocorticoides tubes [Time frame: at 8 weeks]
• Number of dermatocorticoides tubes [Time frame: at 16 weeks as compared to 8 weeks]
• Number of scratches per day (including nights) [Time frame: at 8 weeks]
• Number of scratches per day (including nights) [Time frame: at 16 weeks as compared to 8 weeks]
• Psorasis Area and severity index (PASI Index) for psoriasis group [Time frame: at 8 weeks]
• Psorasis Area and severity index (PASI Index) for psoriasis group [Time frame: at 16 weeks as compared to 8 weeks]
• SCORAD Index for atopic dermatitis [Time frame: at 8 weeks]
• SCORAD Index for atopic dermatitis [Time frame: at 16 weeks as compared to 8 weeks]
• Stress evaluation assessed by Perceived Stress Scale [Time frame: at 8 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Hôpital Saint-Louis — Paris

Identifiers

NCT: NCT05500794 · APHP211191

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗