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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04013867
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Clermont-Ferrand
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sophie Lauron
Principal Investigator Affiliation University Hospital, Clermont-Ferrand
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Depression
Additional Details

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.

Contact a Trial Team

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International Sites

CHU de Clermont-Ferrand, Clermont-Ferrand, France

Status

Recruiting

Address

CHU de Clermont-Ferrand

Clermont-Ferrand, , 63000

Site Contact

Sophie Lauron

slauron@chu-clermontferrand.fr

+33473754.963

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