Atopic DermatitisMediDermInNCT05500794
Meditation in Inflammatory Dermatosis
A study testing MBSR (Mindfulness-Based Stress Reduction) in people with Atopic Dermatitis and Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 days and older
- Conditions the study is for
- Atopic Dermatitis, Psoriasis, Pruritus
- What is being tested?
- MBSR (Mindfulness-Based Stress Reduction)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2022to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint-Louis
Paris, 75010
Charles CASSIUS, +331.42.38.50.49, charles.cassius@aphp.fr
About this study
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)
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.
- Conditions
- Atopic Dermatitis, Psoriasis, Pruritus
- Being tested
- MBSR (Mindfulness-Based Stress Reduction)
- Keywords
- Mindfulness, Based Stress Reduction, Psoriasis, Atopic Dermatitis, Pruritus, Inflammatory Cytokines
- Medical subject headings
- Dermatitis, Atopic, Psoriasis, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR (Mindfulness-Based Stress Reduction)Other
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 group | Role | What they receive |
|---|---|---|
| MBSR (Mindfulness-Based Stress Reduction) group | Experimental | 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. Receives: Other: MBSR (Mindfulness-Based Stress Reduction) |
| Standard group | No intervention | No intervention in this group which will be followed according to the standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus assessed by Visual Analogue Scale (VAS)
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.
Measured: at 8 weeks
Secondary outcomes (17)
Pruritus assessed by Visual Analogue Scale (VAS)
VAS Pruritus scale is a scale going from 0 to 10. 0 corresponds to no pruritus et 10 to the maximum of prurit.
Measured: at 16 weeks
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
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).
Measured: at 8 weeks
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
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).
Measured: at 16 weeks as compared to 8 weeks
Number of dermatocorticoides tubes
Measured: at 8 weeks
Number of dermatocorticoides tubes
Measured: at 16 weeks as compared to 8 weeks
Number of scratches per day (including nights)
Measured: at 8 weeks
Number of scratches per day (including nights)
Measured: at 16 weeks as compared to 8 weeks
Psorasis Area and severity index (PASI Index) for psoriasis group
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.
Measured: at 8 weeks
Psorasis Area and severity index (PASI Index) for psoriasis group
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.
Measured: at 16 weeks as compared to 8 weeks
SCORAD Index for atopic dermatitis
The maximal score of the SCORAD Index is 103.
Measured: at 8 weeks
SCORAD Index for atopic dermatitis
The maximal score of the SCORAD Index is 103.
Measured: at 16 weeks as compared to 8 weeks
Stress evaluation assessed by Perceived Stress Scale
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Measured: at 8 weeks
Stress evaluation assessed by Perceived Stress Scale
It is a 10 questions scale with 5 items per question. Its goes from 10 to 50.
Measured: at 16 weeks as compared to 8 weeks
Quantification of inflammatory stress markers in saliva
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Measured: at 8 weeks
Quantification of inflammatory stress markers in saliva
Saliva stress markers will be alpha-amylase, cortisol, IL-6, IL-31 and TNF-alpha
Measured: at 16 weeks as compared to 8 weeks
Quantification of inflammatory stress markers in serum
Serum stress markers will be CRP, cortisol, IL-6, IL-3, TNF-alpha and Adreno CorticoTropic Hormone
Measured: at 8 weeks
Quantification of inflammatory stress markers in serum
Serum stress markers will be CRP, cortisol, IL-6, IL-31,TNF-alpha and Adreno CorticoTropic Hormone
Measured: at 16 weeks as compared to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start15 Nov 2022
- Primary completion15 Mar 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500794
- Sponsor's protocol ID
- APHP211191
- Acronym
- MediDermIn
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05500794
- Acronym / sponsor ID
- MediDermIn / APHP211191
- Conditions
- Atopic Dermatitis, Psoriasis, Pruritus
- Keywords
- Mindfulness, Based Stress Reduction, Psoriasis, Atopic Dermatitis, Pruritus, Inflammatory Cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR (Mindfulness-Based Stress Reduction) group | Experimental | 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. |
| Standard group | No intervention | –No intervention in this group which will be followed according to the standard care |
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Mild to moderate severity (SCORAD>10)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | MBSR (Mindfulness-Based Stress Reduction) group |
Primary outcome
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.
17 secondary outcomes
Pruritus assessed by Visual Analogue Scale (VAS)
Time frame: at 16 weeks
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
Time frame: at 8 weeks
Pruritus assessed by 5-D Itch Scale 5-D (5-D IQ)
Time frame: at 16 weeks as compared to 8 weeks
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
Psorasis Area and severity index (PASI Index) for psoriasis group
Time frame: at 16 weeks as compared to 8 weeks
SCORAD Index for atopic dermatitis
Time frame: at 8 weeks
SCORAD Index for atopic dermatitis
Time frame: at 16 weeks as compared to 8 weeks
Stress evaluation assessed by Perceived Stress Scale
Time frame: at 8 weeks
Stress evaluation assessed by Perceived Stress Scale
Time frame: at 16 weeks as compared to 8 weeks
Quantification of inflammatory stress markers in saliva
Time frame: at 8 weeks
Quantification of inflammatory stress markers in saliva
Time frame: at 16 weeks as compared to 8 weeks
Quantification of inflammatory stress markers in serum
Time frame: at 8 weeks
Quantification of inflammatory stress markers in serum
Time frame: at 16 weeks as compared to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR (Mindfulness-Based Stress Reduction) in people with Atopic Dermatitis and Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles CASSIUS, Dr (+331.42.38.50.49, charles.cassius@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus assessed by Visual Analogue Scale (VAS) (time frame: at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.