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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR (Mindfulness-Based Stress Reduction) group | Experimental | 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. |
|
| Standard group | No Intervention | No intervention in this group which will be followed according to the standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBSR (Mindfulness-Based Stress Reduction) | Other | 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:
Audio recordings and a manual are provided to support personal practice |
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus assessed by Visual Analogue Scale (VAS) | VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit. | at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus assessed by Visual Analogue Scale (VAS) | VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit. | at 16 weeks |
| Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ) |
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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
OR Patient with atopic dermatitis:
Mild to moderate severity (SCORAD>10)
DLQI > 10
Diagnosis according to Hanifin and Raijka criteria
Exclusion Criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles CASSIUS, Dr | Contact | +331.42.38.50.49 | charles.cassius@aphp.fr | |
| Jérôme Lambert, Pr | Contact | +33142499742 | jerome.lambert@u-paris.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint-Louis | Recruiting | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011565 | Psoriasis |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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The 5-D itch scale is a multidimensional questionnaire. The scores of each of the domains are achieved separately and then summed together : total 5-D score can potentially range between 5 (no pruritus) and 25 (most severe pruritus).
| at 8 weeks |
| Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ) | The 5-D itch scale is a multidimensional questionnaire. The scores of each of the domains are achieved separately and then summed together : total 5-D score can potentially range between 5 (no pruritus) and 25 (most severe pruritus). | at 16 weeks as compared to 8 weeks |
| Number of dermatocorticoides tubes | at 8 weeks |
| Number of dermatocorticoides tubes | at 16 weeks as compared to 8 weeks |
| Number of scratches per day (including nights) | at 8 weeks |
| Number of scratches per day (including nights) | at 16 weeks as compared to 8 weeks |
| Psorasis Area and severity index (PASI Index) for psoriasis group | This score takes into account the affected skin surface, the degree of redness, the thickening of the skin and the scaling. Its ranges from 0 to 72.The higher the number, the more severe the psoriasis. | at 8 weeks |
| Psorasis Area and severity index (PASI Index) for psoriasis group | This score takes into account the affected skin surface, the degree of redness, the thickening of the skin and the scaling. Its ranges from 0 to 72.The higher the number, the more severe the psoriasis. | at 16 weeks as compared to 8 weeks |
| SCORAD Index for atopic dermatitis | The maximal score of the SCORAD Index is 103. | at 8 weeks |
| SCORAD Index for atopic dermatitis | The maximal score of the SCORAD Index is 103. | at 16 weeks as compared to 8 weeks |
| Stress evaluation assessed by Perceived Stress Scale | It is a 10 questions scale with 5 items per question. Its goes from 10 to 50. | at 8 weeks |
| Stress evaluation assessed by Perceived Stress Scale | It is a 10 questions scale with 5 items per question. Its goes from 10 to 50. | at 16 weeks as compared to 8 weeks |
| Quantification of inflammatory stress markers in saliva | Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha | at 8 weeks |
| Quantification of inflammatory stress markers in saliva | Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha | at 16 weeks as compared to 8 weeks |
| Quantification of inflammatory stress markers in serum | Serum stress markers will be CRP, cortisol, IL-6, IL-3, TNF-alpha and Adreno CorticoTropic Hormone | at 8 weeks |
| Quantification of inflammatory stress markers in serum | Serum stress markers will be CRP, cortisol, IL-6, IL-31,TNF-alpha and Adreno CorticoTropic Hormone | at 16 weeks as compared to 8 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |