Meditation in Inflammatory Dermatosis (MediDermIn)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Pruritus; Atopic Dermatitis
• Intervention / Treatment: Other: MBSR (Mindfulness-Based Stress Reduction)

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, Pr; Phone Number: +33142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Charles CASSIUS, Dr; Phone Number: +331.42.38.50.49; Email: charles.cassius@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Hôpital Saint-Louis
    • Contact: Charles CASSIUS; Phone Number: +331.42.38.50.49; Email: charles.cassius@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBSR (Mindfulness-Based Stress Reduction) group; 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.	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 opportunity to ask questions;; Instructions for home practice. Audio recordings and a manual are provided to support personal practice. Audio recordings and a manual are provided to support personal practice
No Intervention: Standard group; No intervention in this group which will be followed according to the standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; Mindfulness; Atopic Dermatitis; Pruritus; Inflammatory Cytokines; Based Stress Reduction
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Papulosquamous; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Psoriasis; Dermatitis; Eczema; Pruritus; Skin Diseases; Dermatitis, Atopic
• Other Study ID Numbers: APHP211191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No