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): Skin Diseases and Conditions – Atopic Dermatitis
2022 AUG 31 (NewsRx) -- By a
As a matter of record, on
Tracking Information
Trial Identifier | NCT05500794 |
First Submitted Date | |
First Posted Date | |
Results First Submitted Date | Not Provided |
Results First Posted Date | Not Provided |
Last Update Submitted Date | |
Last Update Posted Date | |
Primary Completion Date | |
Start Date | |
Current Primary Outcome Measures | •Pruritus assessed by Visual Analogue Scale (VAS) [ Time Frame: 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. |
Current Secondary Outcome Measures | •Pruritus assessed by Visual Analogue Scale (VAS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: at 8 weeks ] | |
•Number of dermatocorticoides tubes [ Time Frame: at 16 weeks as compared to 8 weeks ] | |
•Number of scratches per day (including nights) [ Time Frame: at 8 weeks ] | |
•Number of scratches per day (including nights) [ Time Frame: at 16 weeks as compared to 8 weeks ] | |
•Psorasis Area and severity index (PASI Index) for psoriasis group [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at 8 weeks ] -- The maximal score of the SCORAD Index is 103. | |
•SCORAD Index for atopic dermatitis [ Time Frame: at 16 weeks as compared to 8 weeks ] -- The maximal score of the SCORAD Index is 103. | |
•Stress evaluation assessed by Perceived Stress Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 | |
Other Outcome Measures | Not Provided |
Change History | Complete list of historical revisions of study NCT05500794 |
Descriptive Information
Brief Title | 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) |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Not Applicable |
Study Design | Allocation: Randomized |
Intervention Model: Parallel Assignment | |
Primary Purpose: Other | |
Masking: None (Open Label) | |
Condition | Atopic Dermatitis |
Psoriasis | |
Pruritus | |
Intervention | •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 | |
Study Arms | •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. | |
Interventions: | |
⚬Other: MBSR (Mindfulness-Based Stress Reduction) |
Recruitment Information
Recruitment Status | Not yet recruiting |
Estimated Enrollment | 72 |
Estimated Completion Date | |
Primary Completion Date | |
Eligibility | 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 |
Sex/Gender | Sexes Eligible for Study: All |
Ages | 18 Days and older |
No | |
Contacts | Primary contact: Charles CASSIUS, +331.42.38.50.49, [email protected] |
Backup contact: |
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Listed Location Countries | |
Removed Location Countries |
Administrative Information
NCT Number | NCT05500794 |
Other Study ID Numbers | APHP211191 |
Has Data Monitoring Committee | Not Provided |
Not Provided | |
Plan to Share Data (IPD) Description | Not Provided |
Assistance Publique - Hopitaux de |
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Collaborators | Not Provided |
Investigators | Not Provided |
Information Provided By | Assistance Publique - Hopitaux de |
Verification Date |
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