Actively Recruiting

Phase Not Applicable
Age: 18Days +
All Genders
ID05500794

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

Age: 18Days +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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