NCT05894759

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 17, 2023

Last Update Submit

June 7, 2023

Conditions

PsoriasisStress, PsychologicalDepressionAnxiety

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Psoriasis Area and Severity Index

    6 months

  • Self Administered Psoriasis Area and Severity Index

    6 months

  • The Revised Illness Perception Questionnaire

    6 months

  • Dermatological treatment compliance

    6 months

Study Arms (3)

Music therapy

EXPERIMENTAL

Patients will undergo music therapy, delivered online, for 1 month.

Behavioral: Psychological stress relief techniques

Relaxing stories

SHAM COMPARATOR

Patients will listen to relaxing stories, online, for 1 month.

Behavioral: Psychological stress relief techniques

Treatment as usual

NO INTERVENTION

Dermatological treatment as per national guidelines.

Interventions

Psychological stress relief techniquesBEHAVIORAL

Psychological stress relief techniques

Music therapyRelaxing stories

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of psoriasis
  • adequate psychological stress profile
  • access to a personal computer/ laptop/ smartphone with internet connection
  • agreement to the informed consent form

You may not qualify if:

  • other dermatological conditions which impair the life quality
  • psychological disorders under psychiatric treatment
  • hearing impairment
  • other on-going medical studies
  • pregnancy
  • aliteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Spiridon Emergency Clinical County Hospital- Dermatology department

Iași, 700111, Romania

RECRUITING

MeSH Terms

Conditions

PsoriasisStress, PsychologicalDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Laura Gheuca Solovastru, Prof.

    Grigore T. Popa University of Medicine and Pharmacy Iasi

    STUDY DIRECTOR

Central Study Contacts

Bogdan-Marian Tarcau

CONTACT

0749872910bogdan-marian.tarcau@d.umfiasi.ro

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 17, 2023

First Posted

June 8, 2023

Study Start

June 1, 2023

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

June 9, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)