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

Depression Clinical Trial

Official title:

Psychodermatological Approaches of Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894759
• Other study ID #: 293/14.04.2023
• Status: Recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: Grigore T. Popa University of Medicine and Pharmacy
• Contact: Bogdan-Marian Tarcau
• Phone: 0749872910
• Email: bogdan-marian.tarcau[@]d.umfiasi.ro
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psoriasis
• Stress, Psychological

Intervention

Behavioral:
• Psychological stress relief techniques
Psychological stress relief techniques

Locations

Country	Name	City	State
Romania	Saint Spiridon Emergency Clinical County Hospital- Dermatology department	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Grigore T. Popa University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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