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

Psychodermatological Approaches of Psoriasis

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

Study Overview

• Status: Recruiting
• Conditions: Depression; Stress, Psychological; Psoriasis; Anxiety
• Intervention / Treatment: Behavioral: Psychological stress relief techniques

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bogdan-Marian Tarcau; Phone Number: +40 0749872910; Email: bogdan-marian.tarcau@d.umfiasi.ro

Study Locations

• Romania
  • Iasi, Romania, 700111
    • Recruiting
    • Saint Spiridon Emergency Clinical County Hospital- Dermatology department
    • Contact: Bogdan-Marian Tarcau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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

Collaborators and Investigators

• Sponsor: Grigore T. Popa University of Medicine and Pharmacy
• Investigators: Study Director: Laura Gheuca Solovastru, Prof., Grigore T. Popa University of Medicine and Pharmacy Iasi

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Stress, Psychological
• Other Study ID Numbers: 293/14.04.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No