Non-pharmacological Mitigation of Psoriasis

Study Overview
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Brief Summary
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In the past few years, research has provided evidence for a possibility of dampening immune system by one's will after undergoing a specific training program. Aim of this study was to verity the efficacy in affecting both mind and body by assessing psoriasis activity and psychological functioning. Among the members of both of the groups intensity of skin lesions and pruritus were assessed, consultation regarding treatment took place and multiple questionnaires regarding sleep quality, mindfulness and depressive symptoms were distributed. Blood samples were collected to asses intensity of inflammation, including interleukins.

Detailed Description
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Psoriasis is a skin disease of an unknown origin. Current understanding of its pathophysiology focuses on an undefined imbalance between the immune system and the nervous system. In this study the researchers assessed the effects of a training program which was proven to affect both. A group of psoriatic patients volunteered, and were randomized to either the intervention (n = 19), or control group (n = 19). Subjects in the intervention group were trained for 10 weeks in breathing techniques, exposure to cold and meditation. The control group was not trained. After two weeks of the intervention, a full lockdown due to the COVID-19 pandemics was introduced. Modified protocol included exercises possible to conduct at home only. Two study visits (before and after the intervention) took place. Total count of variables analysed equaled 60. Primary endpoints regarded intensity of psoriasis. This group included laboratory markers (hsCRP, WBC, LEU, MONO, IL-6, IL-8, IL-10, IL-17, TNFalpha) measured in serum and saliva, visual skin assessment performed by a health professional using Psoriasis Area Severity Index, consultations regarding treatment, and results of the questionnaires (Dermatological Life Quality Index, pruritus). Secondary endpoints pertained comorbidities of psoriasis. These were also assessed using questionnaires, and included Pittsburgh Sleep Quality Index, Patient Health Questionnaire - 9 (depressive symptoms), Five Facet Mindfulness Questionnaire, Perceived Stress Scale - 10. The intervention is a specific combination of breathing exercises, meditation and cold exposure. It has been previously proven to have an effect among healthy young males who were able to drop febrile temperatures induced with an intravenously distributed LPS. That phenomena was achieved using previously trained breathing techniques. For 10 weeks members of the intervention group were trained via popular social media platform. Exercises included exposure to cold using regular, cold showers, performing breathing exercises finished with a short meditation session. Length and general difficulty were gradually built up. Initially, total number of the subjects equaled 54. 31 for the intervention group and 23 for the control group. Due to drop-out or meeting the exclusion criteria, final count for both of the groups was 19 participants.

Official Title
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Combination of Breathing Exercises, Cold Exposure, and Meditation Mitigate Psoriasis - Open Label, Randomized, Controlled Trial

Conditions
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Psoriasis, Stress, Inflammation, Depression, Pruritus, Sleep Disorder, Quality of Life

Intervention / Treatment
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* Other: breathing exercises, cold exposure and meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aforementioned Age Confirmed diagnosis of plaque psoriasis Exclusion Criteria: ultraviolet therapy 2 months prior or introduced later during intervention period lifestyle changes defined as changing jobs, introducing a new diet, or sport, or changing their place of residence kidney disease heart disease active infection pregnancy breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups, intervention and control, 10 weeks of intervention. Study visits, blood, saliva collection twice: before and after.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>19 people suffering from psoriasis were performing excersises for 10 weeks | Other: breathing exercises, cold exposure and meditation<br>* It is a combination of exercises that include breathing exercises, cold exposure and meditation<br>|
| No Intervention: Control<br>19 people suffeing from psoriasis that didn't train the exercises | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area Severity Index | Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better | 10 weeks | 
| Dermatology Life Quality Index | Questionnaire regarding the influence of the disease on everyday functioning. Extreme values: 0-30. The lower the value, the better. | 10 weeks | 
| Pruritus Questionnaire | Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better. | 10 weeks | 
| Ointment treatment | Change in ointment treatment - consultation result | 10 weeks | 
| high sensitivity C-reactive protein in serum | Levels of C-reactive protein in serum using high sensitivity measurements | 10 weeks | 
| Interleukin 6 in serum | Level of interleukin 6 in measured serum | 10 weeks | 
| Interleukin 6 in saliva | Level of interleukin 6 in measured saliva | 10 weeks | 
| Interleukin 8 in serum | Level of interleukin 8 measured in saliva | 10 weeks | 
| Interleukin 8 in saliva | Levels of interleukin 8 measured in saliva | 10 weeks | 
| Interleukin 10 in serum | Levels of interleukin 10 measured in serum | 10 weeks | 
| Interleukin 10 in saliva | Levels of interleukine 10 measured in saliva | 10 weeks | 
| Tumor Necrosis Factor alpha in serum | Levels of Tumor Necrosis Factor in serum | 10 weeks | 
| Tumor Necrosis Factor alpha in saliva | Levels of Tumor Necrosis Factor in saliva | 10 weeks | 
| Monocyte count | Monocyte count in peripheral blood morphology | 10 weeks | 
| Lymphocyte count | Lymphocyte count in peripheral blood morphology | 10 weeks | 
| Platelet count | Platelet count in peripheral blood morphology | 10 weeks | 
| Neutrophil count | Neutrophil count in peripheral blood morphology | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five Facet Mindfulness Questionnaire - total score | Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better. | 10 weeks | 
| Non-Judgement component of the Five Facet Mindfulness Questionnaire | Index regarding skill of restraining from labeling. Extreme values: 8-40. The higher the score, the better | 10 weeks | 
| Non-Reactivity component of the Five Facet Mindfulness Questionnaire | Index measuring skill of restraining from uncontrolled reactions. Extreme values: 7-35. The higher the score, the better | 10 weeks | 
| Observation component of the Five Facet Mindfulness Questionnaire | Index regarding objective observation. Extreme values: 8-40. The higher the score, the better | 10 weeks | 
| Acting with awareness component of the Five Facet Mindfulness Questionnaire | Index regarding everyday awareness. Extreme values: 8-40. The higher the score, the better | 10 weeks | 
| Describing component of the Five Facet Mindfulness Questionnaire | Index regarding skill of objective describing. Extreme values: 8-40. The higher the score, the better | 10 weeks | 
| Perceived Stress Scale - 10 | Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better. | 10 weeks | 
| Patient Health Questionnaire - 9 | Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better | 10 weeks | 
| Pittsburgh Sleep Quality Index | Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meditation, exposure to cold, inflammation, breathing