NCT04013867

Brief Summary

Prevalence of depression shows great heterogeneity in patients with psoriasis. This could be explained by the psychometric properties of the questionnaires assessing depressive symptoms: these tests have not been developed in a context of dermatosis. The complaints and symptoms associated with psoriasis can be misidentified by questionnaires as a manifestation of depressive symptomatology and may overestimate depressive symptoms. In other diseases such as asthma and rheumatoid arthritis, tools have been validated specifically to take into account these symptoms. The purpose of this study is to validate and compare assessment tools for depression in patients with psoriasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

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

July 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2021

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

July 8, 2019

Last Update Submit

July 21, 2023

Conditions

PsoriasisDepression

Keywords

psoriasisdepressionvalidationself-questionnaire

Outcome Measures

Primary Outcomes (4)

  • Diagnostic performance in term of specificity of self-questionnaires assessing depression in relation to the diagnosis made during the interview using the MINI (Mini International neuropsychiatric Interview)

    Comparison of specificity between each self-questionnaires (PHQ9- Patient health Questionnaire, BDI - Beck Depression Inventory, HADS, Hospital Anxiety and Depression Scale-Depression, IDS, Inventory of Depressive Symptomatology ). Threshold values will be determined with the ROC curves according to presence of depression or not (identified during with the MINI).

    Day 7

  • Diagnostic performance in term of positive predictive value of self-questionnaires assessing depression in relation to the diagnosis made during the interview using the MINI (Mini International neuropsychiatric Interview)

    Comparison of positive predictive values according to threshold values between each self-questionnaires (PHQ9- Patient health Questionnaire, BDI - Beck Depression Inventory, HADS, Hospital Anxiety and Depression Scale-Depression, IDS, Inventory of Depressive Symptomatology ). Threshold values will be determined with the ROC curves according to presence of depression or not (identified during with the MINI).

    Day 7

  • Diagnostic performance in term of sensitivity of self-questionnaires assessing depression in relation to the diagnosis made during the interview using the MINI (Mini International neuropsychiatric Interview)

    Comparison of sensitivity between each self-questionnaires (PHQ9- Patient health Questionnaire, BDI - Beck Depression Inventory, HADS, Hospital Anxiety and Depression Scale-Depression, IDS, Inventory of Depressive Symptomatology ). Threshold values will be determined with the ROC curves according to presence of depression or not (identified during with the MINI).

    Day 7

  • Diagnostic performance in term of negative predictive value of self-questionnaires assessing depression in relation to the diagnosis made during the interview using the MINI (Mini International neuropsychiatric Interview)

    Comparison of negative predictive values according to threshold values between each self-questionnaires (PHQ9- Patient health Questionnaire, BDI - Beck Depression Inventory, HADS, Hospital Anxiety and Depression Scale-Depression, IDS, Inventory of Depressive Symptomatology ). Threshold values will be determined with the ROC curves according to presence of depression or not (identified during with the MINI).

    Day 7

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with psoriasis

You may qualify if:

  • Major patient, male or female, with psoriasis, less than 65 years old, followed up in the dermatology or rheumatology departments of the University Hospital of Clermont-Ferrand.
  • Able to mentally and linguistically answer the proposed questionnaires.
  • Can fill out online questionnaires from his home.
  • Affiliated with Social Security.

You may not qualify if:

  • Major incapable patient
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

PsoriasisDepression

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehavior

Study Officials

  • Sophie Lauron

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 10, 2019

Study Start

July 22, 2019

Primary Completion

June 7, 2021

Study Completion

June 7, 2021

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

FR(1)