Clinical trial NCT05500794: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Psoriasis
Pruritus
Keywords: Mindfulness
Based Stress Reduction
Psoriasis
Atopic Dermatitis
Pruritus
Inflammatory Cytokines
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Pruritus assessed by Visual Analogue Scale (VAS)
timeFrame: at 8 weeks
Secondary outcomes:
measure: Pruritus assessed by Visual Analogue Scale (VAS)
timeFrame: at 16 weeks
measure: Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
timeFrame: at 8 weeks
measure: Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
timeFrame: at 16 weeks as compared to 8 weeks
measure: Number of dermatocorticoides tubes
timeFrame: at 8 weeks
measure: Number of dermatocorticoides tubes
timeFrame: at 16 weeks as compared to 8 weeks
measure: Number of scratches per day (including nights)
timeFrame: at 8 weeks
measure: Number of scratches per day (including nights)
timeFrame: at 16 weeks as compared to 8 weeks
measure: Psorasis Area and severity index (PASI Index) for psoriasis group
timeFrame: at 8 weeks
measure: Psorasis Area and severity index (PASI Index) for psoriasis group
timeFrame: at 16 weeks as compared to 8 weeks
measure: SCORAD Index for atopic dermatitis
timeFrame: at 8 weeks
measure: SCORAD Index for atopic dermatitis
timeFrame: at 16 weeks as compared to 8 weeks
measure: Stress evaluation assessed by Perceived Stress Scale
timeFrame: at 8 weeks
measure: Stress evaluation assessed by Perceived Stress Scale
timeFrame: at 16 weeks as compared to 8 weeks
measure: Quantification of inflammatory stress markers in saliva
timeFrame: at 8 weeks
measure: Quantification of inflammatory stress markers in saliva
timeFrame: at 16 weeks as compared to 8 weeks
measure: Quantification of inflammatory stress markers in serum
timeFrame: at 8 weeks
measure: Quantification of inflammatory stress markers in serum
timeFrame: at 16 weeks as compared to 8 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis
Study officials:
References: