PsoriasisDePsoValNCT04013867
Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis (DePsoVal)
An observational study of Psoriasis and Depression, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis, Depression
- How many people
- 289 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2019to 7 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with psoriasis
Who may be able to join
- 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.
Who cannot join
- Major incapable patient
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis
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.
Read the 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.
- Telephone interview (5 minutes) Presentation of the study. Schedule a telephone appointment 3 days later.
- 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).
- 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.
- 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
- Keywords
- psoriasis, depression, validation, self-questionnaire
- Medical subject headings
- Psoriasis, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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).
Measured: Day 7
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)
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).
Measured: Day 7
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)
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).
Measured: Day 7
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)
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).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start22 Jul 2019
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Lauron, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013867
- Sponsor's protocol ID
- RNI 2019 LAURON
- Other IDs
- 2019-A01119-48
- Acronym
- DePsoVal
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2019
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT04013867
- Acronym / sponsor ID
- DePsoVal / RNI 2019 LAURON
- Conditions
- Psoriasis, Depression
- Keywords
- psoriasis, depression, validation, self-questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Telephone interview (5 minutes) Presentation of the study. Schedule a telephone appointment 3 days later.
- 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).
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with psoriasis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Major incapable patient
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Time frame: Day 7
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).
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)
Time frame: Day 7
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).
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)
Time frame: Day 7
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).
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)
Time frame: Day 7
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Lauron principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Depression, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.