Depression Clinical Trial
Official title:
Combination of Breathing Exercises, Cold Exposure, and Meditation Mitigate Psoriasis - Open Label, Randomized, Controlled Trial
Verified date | September 2021 |
Source | Medical University of Lodz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | October 6, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology | Lódz | Lódzkie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Lodz |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psoriasis Area Severity Index | Visual assessment of the skin condition. Extreme values: 0-72. The lower the score, the better | 10 weeks | |
Primary | 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 | |
Primary | Pruritus Questionnaire | Intensity of pruritus measured with a questionnaire. Extreme values 0-18. The lower the score, the better. | 10 weeks | |
Primary | Ointment treatment | Change in ointment treatment - consultation result | 10 weeks | |
Primary | high sensitivity C-reactive protein in serum | Levels of C-reactive protein in serum using high sensitivity measurements | 10 weeks | |
Primary | Interleukin 6 in serum | Level of interleukin 6 in measured serum | 10 weeks | |
Primary | Interleukin 6 in saliva | Level of interleukin 6 in measured saliva | 10 weeks | |
Primary | Interleukin 8 in serum | Level of interleukin 8 measured in saliva | 10 weeks | |
Primary | Interleukin 8 in saliva | Levels of interleukin 8 measured in saliva | 10 weeks | |
Primary | Interleukin 10 in serum | Levels of interleukin 10 measured in serum | 10 weeks | |
Primary | Interleukin 10 in saliva | Levels of interleukine 10 measured in saliva | 10 weeks | |
Primary | Tumor Necrosis Factor alpha in serum | Levels of Tumor Necrosis Factor in serum | 10 weeks | |
Primary | Tumor Necrosis Factor alpha in saliva | Levels of Tumor Necrosis Factor in saliva | 10 weeks | |
Primary | Monocyte count | Monocyte count in peripheral blood morphology | 10 weeks | |
Primary | Lymphocyte count | Lymphocyte count in peripheral blood morphology | 10 weeks | |
Primary | Platelet count | Platelet count in peripheral blood morphology | 10 weeks | |
Primary | Neutrophil count | Neutrophil count in peripheral blood morphology | 10 weeks | |
Secondary | Five Facet Mindfulness Questionnaire - total score | Total result of FFMQ. Extreme values: 39 - 195. The higher the score, the better. | 10 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Observation component of the Five Facet Mindfulness Questionnaire | Index regarding objective observation. Extreme values: 8-40. The higher the score, the better | 10 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Perceived Stress Scale - 10 | Questionnaire regarding everyday stress. Extreme values 0-40. The lower the score, the better. | 10 weeks | |
Secondary | Patient Health Questionnaire - 9 | Questionnaire regarding depressive symptoms. Extreme values 0 - 27. The lower the score, the better | 10 weeks | |
Secondary | Pittsburgh Sleep Quality Index | Questionnaire regarding sleep quality. Extreme values 0 - 21, the lower the score, the better | 10 weeks |
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