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

Sponsor

Grigore T. Popa University of Medicine and Pharmacy (Other)

Overall Status

Recruiting

CT.gov ID

NCT05894759

Collaborator

(none)

105

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Stress, Psychological Depression Anxiety	Behavioral: Psychological stress relief techniques	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Psychodermatological Approaches of Psoriasis

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Dermatological Life Quality Index [6 months]
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)
Psychological stress [6 months]
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)
General Anxiety Disorder-7 [6 months]
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)
Patient Health Questionnaire-9 [6 months]
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)

Secondary Outcome Measures

Psoriasis Area and Severity Index [6 months]
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)
Self Administered Psoriasis Area and Severity Index [6 months]
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)
The Revised Illness Perception Questionnaire [6 months]
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)
Dermatological treatment compliance [6 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Spiridon Emergency Clinical County Hospital- Dermatology department	Iasi		Romania	700111

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bogdan-Marian Tarcau, Principal investigator, Grigore T. Popa University of Medicine and Pharmacy

ClinicalTrials.gov Identifier:

NCT05894759

Other Study ID Numbers:

293/14.04.2023

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psoriasis

Stress, Psychological

Study Results

No Results Posted as of Jun 9, 2023