The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level

Study Overview
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Brief Summary
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Two mind-relaxing techniques will be applied to psoriasis patients with an elevated psychological stress profile at baseline

Official Title
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Psychodermatological Approaches of Psoriasis

Conditions
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Psoriasis, Stress, Psychological, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Psychological stress relief techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of psoriasis adequate psychological stress profile access to a personal computer/ laptop/ smartphone with internet connection agreement to the informed consent form Exclusion Criteria: other dermatological conditions which impair the life quality psychological disorders under psychiatric treatment hearing impairment other on-going medical studies pregnancy aliteracy

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music therapy<br>Patients will undergo music therapy, delivered online, for 1 month. | Behavioral: Psychological stress relief techniques<br>* Psychological stress relief techniques<br>|
| Sham Comparator: Relaxing stories<br>Patients will listen to relaxing stories, online, for 1 month. | Behavioral: Psychological stress relief techniques<br>* Psychological stress relief techniques<br>|
| No Intervention: Treatment as usual<br>Dermatological treatment as per national guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatological Life Quality Index | Dermatological Life Quality Index Score will be calculated at baseline, 1 month and 6 months. Dermatological Life Quality Index minimum score = 0 (no impairment of life quality) Dermatological Life Quality Index maximum score = 30 (maximum impairment of life quality) | 6 months | 
| Psychological stress | A visual analog scale will be used at baseline, 1 month and 6 months. Analog scale minimum value = 0 (no stress) Analog scale maximum value = 10 (maximum stress) | 6 months | 
| General Anxiety Disorder-7 | General Anxiety Disorder-7 questionnaire will be applied at baseline, 1 month and 6 months. General anxiety disorded-7 minimum score = 0 (no anxiety) General anxiety disorded-7 maximum score = 21 (maximum anxiety) | 6 months | 
| Patient Health Questionnaire-9 | Patient Health Questionnaire-9 will be applied at baseline, 1 month and 6 months. Patient Health Questionnaire-9 minimum score = 0 (no depression) Patient Health Questionnaire-9 maximum score = 27 (maximum depression) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index | Psoriasis Area and Severity Index score will be calculated will be applied at baseline, 1 month and 6 months. Psoriasis Area and Severity Index minimum score = 0 (no severity - no lesions) Psoriasis Area and Severity Index maximum score = 72 (maximum severity) | 6 months | 
| Self Administered Psoriasis Area and Severity Index | The self Administered Psoriasis Area and Severity Index score will be calculated by the patient at baseline, 1 month and 6 months. The self Administered Psoriasis Area and Severity Index minimum score = 0 (no severity - no lesions) The self Administered Psoriasis Area and Severity Index maximum score = 72 (maximum severity) | 6 months | 
| The Revised Illness Perception Questionnaire | The Revised Illness Perception Questionnaire will be applied at baseline, 1 month and 6 months. The Revised Illness Perception Questionnaire minimum score = 0 (best illness perception) The Revised Illness Perception Questionnaire maximum score = 80 (worst illness perception) | 6 months | 
| Dermatological treatment compliance | A visual analog scale will be applied at baseline, 1 month and 6 months. Analog scale minimum value = 0 (total lack of compliance) Analog scale maximum value = 10 (maximum compliance) | 6 months |