Actively Recruiting
Evaluation of Mindfulness-Based Stress Reduction as Additional Therapy for Moderate Itchy Psoriasis or Atopic Dermatitis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-09-19
72
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Psoriasis and atopic dermatitis are common inflammatory skin conditions involving severe itching and skin inflammation, affecting over 120 million people worldwide. These diseases cause distress due to intense itching that leads to a cycle of scratching and worsened symptoms, impacting quality of life and mental health. Researchers are evaluating whether mindfulness meditation, a mental training method to regulate stress and emotions, can reduce itching and improve well-being in patients with moderate pruritic psoriasis or atopic dermatitis who are not using systemic treatments. The study compares two groups: one participates in an 8-week Mindfulness-Based Stress Reduction (MBSR) program featuring weekly 2.5-hour sessions, longer first and last sessions, an optional 6-hour intensive practice day, and guidance by an instructor using meditation, stretching, yoga, and group discussions. The other group receives standard care with no additional intervention. Audio recordings and a manual support home practice for the MBSR group. Participants will be assessed for itching severity using the Visual Analogue Scale (VAS) at 8 weeks as the primary outcome. Additional evaluations include itch scales, stress markers in saliva and serum, skin lesion severity indexes, number of scratches per day, use of dermatocorticoids, and psychological stress scales at 8 and 16 weeks. The study involves randomized allocation without blinding and monitors changes in symptoms and quality of life over this period.
CONDITIONS
Brief Title
Meditation in Inflammatory Dermatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years old or older
- Health insurance coverage
- Significant itching with a Visual Analogical Scale (VAS) score of 4 or higher
- Diagnosis of plaque psoriasis without joint involvement, mild to moderate severity (PASI > 10), and Dermatology Life Quality Index (DLQI) over 10
- OR diagnosis of mild to moderate atopic dermatitis (SCORAD > 10) with DLQI over 10 according to Hanifin and Raijka criteria
- Stable psychological state
- French language spoken
You will not qualify if you...
- Current systemic treatment or treatment stopped within the last month
- Diagnosed psychiatric illnesses including psychotic disorder, severe anxiety disorder, severe depressive episode, or bipolar disorder with current episode
- Use of psychotropic or neuroleptic medications
- Participation in another interventional research study or within exclusion period after previous study
- Patient under AME (State Medical Aid) coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants in the MBSR group attend weekly mindfulness-based stress reduction sessions to help manage symptoms of psoriasis or atopic dermatitis. Sessions include guided meditation, yoga, group discussions, and home practice instructions.
8 weekly sessions (in-person)
Duration - 8 weeks
Participants are monitored for symptom changes and stress levels after the treatment period ends.
1 visit at 16 weeks (in-person)
Trial Site Locations
Total: 1 location
1
Hôpital Saint-Louis
Paris, France, 75010
Actively Recruiting
Research Team
C
Charles CASSIUS, Dr
J
Jérôme Lambert, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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