Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-02-21 @ 7:15 AM
Study NCT ID:
NCT04013867
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis (DePsoVal)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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).'}, {'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', 'description': '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).'}, {'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', 'description': '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).'}, {'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', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psoriasis', 'depression', 'validation', 'self-questionnaire'], 'conditions': ['Psoriasis', 'Depression']}, 'descriptionModule': {'briefSummary': '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.\n\nIn other diseases such as asthma and rheumatoid arthritis, tools have been validated specifically to take into account these symptoms.\n\nThe purpose of this study is to validate and compare assessment tools for depression in patients with psoriasis.', 'detailedDescription': '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.\n\n1. Telephone interview (5 minutes) Presentation of the study. Schedule a telephone appointment 3 days later.\n2. 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.\n\n Semi-directed telephone interview to identify the presence of depressive or dysthymic disorders (MINI).\n3. 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.\n\n Self-questionnaires BDI, PHQ9, IDS, QIDS, HADS assessing the intensity of depressive symptoms.\n4. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with psoriasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Able to mentally and linguistically answer the proposed questionnaires.\n* Can fill out online questionnaires from his home.\n* Affiliated with Social Security.\n\nExclusion Criteria:\n\n* Major incapable patient\n* Refusal of participation'}, 'identificationModule': {'nctId': 'NCT04013867', 'acronym': 'DePsoVal', 'briefTitle': 'Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis (DePsoVal)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis', 'orgStudyIdInfo': {'id': 'RNI 2019 LAURON'}, 'secondaryIdInfos': [{'id': '2019-A01119-48', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Sophie Lauron', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}