MediDermIn: Meditation in Inflammatory Dermatosis

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05500794

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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. Our 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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis Psoriasis Pruritus	Other: MBSR (Mindfulness-Based Stress Reduction)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: MBSR (Mindfulness-Based Stress Reduction) group

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

Outcome Measures

Primary Outcome Measures

Pruritus assessed by Visual Analogue Scale (VAS) [at 8 weeks]
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.

Secondary Outcome Measures

Pruritus assessed by Visual Analogue Scale (VAS) [at 16 weeks]
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ) [at 8 weeks]
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).
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ) [at 16 weeks as compared to 8 weeks]
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).
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 [at 8 weeks]
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.
Psorasis Area and severity index (PASI Index) for psoriasis group [at 16 weeks as compared to 8 weeks]
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.
SCORAD Index for atopic dermatitis [at 8 weeks]
The maximal score of the SCORAD Index is 103.
SCORAD Index for atopic dermatitis [at 16 weeks as compared to 8 weeks]
The maximal score of the SCORAD Index is 103.
Stress evaluation assessed by Perceived Stress Scale [at 8 weeks]
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Stress evaluation assessed by Perceived Stress Scale [at 16 weeks as compared to 8 weeks]
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Quantification of inflammatory stress markers in saliva [at 8 weeks]
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Quantification of inflammatory stress markers in saliva [at 16 weeks as compared to 8 weeks]
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Quantification of inflammatory stress markers in serum [at 8 weeks]
Serum stress markers will be CRP, cortisol, IL-6, IL-3, TNF-alpha and Adreno CorticoTropic Hormone
Quantification of inflammatory stress markers in serum [at 16 weeks as compared to 8 weeks]
Serum stress markers will be CRP, cortisol, IL-6, IL-31,TNF-alpha and Adreno CorticoTropic Hormone

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Days and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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