Non-pharmacological Mitigation of Psoriasis

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745429
• Other study ID #: RNN/347/18/KE
• Status: Completed
• Phase: N/A
• Start date: February 19, 2020
• Est. completion date: October 6, 2020

Study information

• Verified date: September 2021
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Depression
• Inflammation
• Pruritus
• Psoriasis
• Quality of Life
• Sleep Disorder
• Sleep Wake Disorders
• Stress

Intervention

Other:
• breathing exercises, cold exposure and meditation
It is a combination of exercises that include breathing exercises, cold exposure and meditation

Locations

Country	Name	City	State
Poland	Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology	Lódz	Lódzkie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

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