Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis (DePsoVal)

NCT ID: NCT04013867

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 289 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2021-06-07

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.

Detailed Description

The study does not modify the management of patients. Patients will be contacted by phone. The protocol, the modalities and the objectives of the study will be presented during a first telephone interview. A second telephone interview will be scheduled with the patient 3 days later for the collection of his informed consent, if he agrees to participate, and the completion of the questionnaires of the study. The online questionnaires will be sent by email during this call.

1. Telephone interview (5 minutes) Presentation of the study. Schedule a telephone appointment 3 days later.

2. Telephone interview (10 minutes) Collection of consent. Sociodemographic questionnaire: sex, age, marital status, level of education Medical questionnaire including the consumption of tobacco and alcohol, the collection of current treatments, their indications and their start dates.

Semi-directed telephone interview to identify the presence of depressive or dysthymic disorders (MINI).

3. mailing of the self-questionnaires (20 to 30 minutes) Medical questionnaire: duration of psoriasis, simplified index of psoriasis, presence of pruritus, pain EVA (cutaneous and articular), fatigue.

Self-questionnaires BDI, PHQ9, IDS, QIDS, HADS assessing the intensity of depressive symptoms.

4. Retest (10 minutes) Some patients will be offered to re-fill the self-questionnaires assessing the intensity of depressive symptoms 15 days after completion of the survey. All participants selected for the retest will not complete all questionnaires again: the questionnaires will be distributed among the patients. The retest requires 50 patients who declare themselves stable (identified by one item) for each questionnaire.

Conditions

Psoriasis; Depression

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Major incapable patient
• Refusal of participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Lauron

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2019-A01119-48

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2019 LAURON

Identifier Type: -

Identifier Source: org_study_id