Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-28 @ 10:36 PM
Study NCT ID:
NCT04013867
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2019-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis (DePsoVal)
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DePsoVal
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A01119-48 | OTHER | ANSM | View |