Non-pharmacological Mitigation of Psoriasis

NCT04745429 | Completed

• 1 other identifier: RNN/347/18/KE
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis; Stress; Inflammation; Depression; Pruritus; Sleep Disorder; Quality of Life

Keywords

meditation; exposure to cold; inflammation; breathing

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (9)

• Five Facet Mindfulness Questionnaire - total score

  10 weeks

• Non-Judgement component of the Five Facet Mindfulness Questionnaire

  10 weeks

• Non-Reactivity component of the Five Facet Mindfulness Questionnaire

  10 weeks

• Observation component of the Five Facet Mindfulness Questionnaire

  10 weeks

• Acting with awareness component of the Five Facet Mindfulness Questionnaire

  10 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

19 people suffering from psoriasis were performing excersises for 10 weeks

Other: breathing exercises, cold exposure and meditation

Control

NO INTERVENTION

19 people suffeing from psoriasis that didn't train the exercises

Interventions

breathing exercises, cold exposure and meditation OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aforementioned Age
• Confirmed diagnosis of plaque psoriasis

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical Univeristy of Lodz, Chair of Clinical Immunology and Rheumatology

Lodz, Łódź Voivodeship, 92-213, Poland

Location

MeSH Terms

Conditions

Psoriasis; Inflammation; Depression; Pruritus; Sleep Wake Disorders; Respiratory Aspiration

Interventions

Breathing Exercises; Meditation

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Skin Manifestations; Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anna Zalewska-Janowska, professor

  Psychodermatology Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is impossible to conduct a masked trial as the intervention is collection of exercises that have to be taught by an instructor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups, intervention and control, 10 weeks of intervention. Study visits, blood, saliva collection twice: "before" and "after".

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 9, 2021
• Study Start: February 19, 2020
• Primary Completion: April 30, 2020
• Study Completion: October 6, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

PL (1)