Clinical trial NCT04013867: Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis (DePsoVal)
Official title: Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Depression
Keywords: psoriasis
depression
validation
self-questionnaire
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with psoriasis

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.

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

Primary outcomes:
measure: 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)
timeFrame: Day 7
measure: 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)
timeFrame: Day 7
measure: 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)
timeFrame: Day 7
measure: 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)
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sophie Lauron
role: PRINCIPAL_INVESTIGATOR
References: