Meditation in Inflammatory Dermatosis

NCT05500794 | Recruiting

• 1 other identifier: APHP211191
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Atopic Dermatitis; Psoriasis; Pruritus

Keywords

Mindfulness; Based Stress Reduction; Psoriasis; Atopic Dermatitis; Pruritus; Inflammatory Cytokines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Pruritus assessed by Visual Analogue Scale (VAS)

  at 16 weeks

• Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)

  at 8 weeks

• Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)

  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

Study Arms (2)

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.

Other: MBSR (Mindfulness-Based Stress Reduction)

Standard group

NO INTERVENTION

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

Interventions

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: * 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

MBSR (Mindfulness-Based Stress Reduction) group

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient under AME

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Louis

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis; Pruritus

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Charles CASSIUS, Dr

CONTACT

+331.42.38.50.49; charles.cassius@aphp.fr

Jérôme Lambert, Pr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: November 15, 2022
• Primary Completion: March 15, 2026
• Study Completion: May 15, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

FR (1)