Mental IllnessDEPSYSTAGENCT07396623
Validation of French PHQ-4 and PC-PTSD-5 Screening Scales
An observational study of Mental Illness, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Mental illness is a major public health issue. It affects one in five people, represents the largest expense for health insurance (14%), is the leading cause of years lived with disability, and suicide is the main cause of death among people aged 15 to 35. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2026to 15 Aug 2027
- How long will I take part?
- 554 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve adult patients, regardless of sex, who present for consultation.
Who may be able to join
- Age ≥ 18 years,
- Outpatient or hospitalized for any health-related reason,
- Oral and written proficiency in French,
- Patient informed and willing to participate in the study,
- Patient with health insurance coverage
Who cannot join
- Individuals under legal protection measures (guardianship, conservatorship, or legal supervision),
- Other factors preventing obtaining non-opposition or conducting the research, such as: limited French proficiency, hearing impairment, or significant cognitive disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Avicenne
Bobigny, 93000
Vladimir ADRIEN, Doctor, +33148955421, vladimir.adrien@aphp.fr
Gaelle Colevray, gaellecolevray@gmail.com
About this study
Official title: Validation of the French Versions of the PHQ-4 Anxiety and Depression Scale and the PC-PTSD-5 Post-Traumatic Stress Disorder Screening Scale
Mental illness is a major public health issue. It affects one in five people, represents the largest expense for health insurance (14%), is the leading cause of years lived with disability, and suicide is the main cause of death among people aged 15 to 35. Depression affects 15 to 20% of individuals at some point in their lives. Trauma-related disorders affect 4.6% of people, including 1- 2% with post-traumatic stress disorder (PTSD).
Screening for mental health problems in primary care is crucial. It enables doctors to provide early treatment, reduces the need for emergency care, and decreases both the number and duration of hospital stays. However, general practitioners and other non-mental health professionals often report lacking the time, training, and tools to conduct such screenings. Fortunately, brief and validated screening tools exist in English: The PHQ-4 (Patient Health Questionnaire-4) for anxiety and depression, and the PC-PTSD-5 (Primary Care PTSD Screen for DSM-5) for PTSD. So far, no French versions of these tools have been validated.
Read the detailed description
A target of 10 patients per item of the tested scales was set. The PHQ-4 includes four items and the PC-PTSD-5 includes five items, corresponding to required sample sizes of 40 and 50 patients, respectively. Although the same patient sample completes both scales, these sample sizes were combined to account for potential loss to follow-up and to optimize statistical power, resulting in a total inclusion target of 90 patients.
Descriptive analyses of sociodemographic and clinical characteristics will be conducted for all included patients. Quantitative variables will be summarized using means and standard deviations, and qualitative variables using frequencies and percentages.
To address the primary objective, convergent validity will be assessed using Pearson's correlation coefficients between scores obtained on the tested scales (PHQ-4 and PC-PTSD-5) and those obtained on their respective gold standard instruments (PHQ-9, GAD-7, and PCL-5). Convergent validity will also be examined by inclusion center through comparison of correlation coefficients across centers.
Secondary objectives will be addressed through:
- Exploratory factor analysis to examine the dimensional structure of each scale and to compare it with that of the corresponding gold standard.
- Assessment of internal consistency using Cronbach's alpha coefficient. Test-retest reliability will be evaluated using the intraclass correlation coefficient on a subsample of at least 20 participants, depending on the final total sample size, who will complete the PHQ-4 and PC-PTSD-5 scales twice.
- Evaluation of diagnostic performance by calculating sensitivity and specificity for each scale among patients undergoing a psychiatric diagnostic assessment, with receiver operating characteristic (ROC) curves generated for each scale.
- Assessment of feasibility based on the time required to complete both scales.
All statistical tests will be two-sided and considered statistically significant at an alpha level of 0.05.
No statistical imputation methods will be used for the management of missing data.
- Conditions
- Mental Illness
- Keywords
- Post-Traumatic Stress Disorder, Depression, Anxiety, Screening tool
- Medical subject headings
- Mental Disorders, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the validity of the French version of the PHQ-4 (Patient Health Questionnaire-4 ) scale
This scale is used for the screening of anxiety and depression. The scale will be scored.
Score ranging from 0 to 12, corresponding to four levels of psychological distress:
- None: 0-2
- Mild: 3-5
- Moderate: 6-8
- Severe: 9-12 Patients will complete this scale at Visit 1 and Visit 2.
Measured: 14 days
Assess the validity of the French version of the PC-TDSD-5 (Primary Care PTSD Screen for DSM-5) scale
Scale assessing whether the patient has experienced unusually or particularly frightening, horrible, or traumatic events. Examples include:
- A serious accident or fire
- Physical or sexual assault, or sexual abuse
- An earthquake or flood
- War
- Witnessing a person being killed or seriously injured
- The death of a close person by homicide or suicide Total score = sum of "YES" responses to questions 1 through 5. Patients will complete this scale at Visit 1 and Visit 2.
Measured: 14 days
Secondary outcomes (1)
Assess the feasibility of this screening tool during the first evaluation visit.
The time required for the patient to complete each scale (individually) will be timed and recorded (without informing the patient in order to avoid potential stress).
Measured: At Visit 1 (at inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start26 Jan 2026
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 554 Days
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396623
- Sponsor's protocol ID
- APHP250750
- Acronym
- DEPSYSTAGE
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Versions of the PHQ-4 Anxiety and Depression Scale and the PC-PTSD-5 Post-Traumatic Stress Disorder Screening Scale
- ClinicalTrials.gov ID
- NCT07396623
- Acronym / sponsor ID
- DEPSYSTAGE / APHP250750
- Conditions
- Mental Illness
- Keywords
- Post-Traumatic Stress Disorder, Depression, Anxiety, Screening tool
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 9 Feb 2026 (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.
Mental illness is a major public health issue. It affects one in five people, represents the largest expense for health insurance (14%), is the leading cause of years lived with disability, and suicide is the main cause of death among people aged 15 to 35. Depression affects 15 to 20% of individuals at some point in their lives. Trauma-related disorders affect 4.6% of people, including 1- 2% with post-traumatic stress disorder (PTSD).
Screening for mental health problems in primary care is crucial. It enables doctors to provide early treatment, reduces the need for emergency care, and decreases both the number and duration of hospital stays. However, general practitioners and other non-mental health professionals often report lacking the time, training, and tools to conduct such screenings. Fortunately, brief and validated screening tools exist in English: The PHQ-4 (Patient Health Questionnaire-4) for anxiety and depression, and the PC-PTSD-5 (Primary Care PTSD Screen for DSM-5) for PTSD. So far, no French versions of these tools have been validated.
Detailed description
A target of 10 patients per item of the tested scales was set. The PHQ-4 includes four items and the PC-PTSD-5 includes five items, corresponding to required sample sizes of 40 and 50 patients, respectively. Although the same patient sample completes both scales, these sample sizes were combined to account for potential loss to follow-up and to optimize statistical power, resulting in a total inclusion target of 90 patients.
Descriptive analyses of sociodemographic and clinical characteristics will be conducted for all included patients. Quantitative variables will be summarized using means and standard deviations, and qualitative variables using frequencies and percentages.
To address the primary objective, convergent validity will be assessed using Pearson's correlation coefficients between scores obtained on the tested scales (PHQ-4 and PC-PTSD-5) and those obtained on their respective gold standard instruments (PHQ-9, GAD-7, and PCL-5). Convergent validity will also be examined by inclusion center through comparison of correlation coefficients across centers.
Secondary objectives will be addressed through:
- Exploratory factor analysis to examine the dimensional structure of each scale and to compare it with that of the corresponding gold standard.
- Assessment of internal consistency using Cronbach's alpha coefficient. Test-retest reliability will be evaluated using the intraclass correlation coefficient on a subsample of at least 20 participants, depending on the final total sample size, who will complete the PHQ-4 and PC-PTSD-5 scales twice.
- Evaluation of diagnostic performance by calculating sensitivity and specificity for each scale among patients undergoing a psychiatric diagnostic assessment, with receiver operating characteristic (ROC) curves generated for each scale.
- Assessment of feasibility based on the time required to complete both scales.
All statistical tests will be two-sided and considered statistically significant at an alpha level of 0.05.
No statistical imputation methods will be used for the management of missing data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 554 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve adult patients, regardless of sex, who present for consultation.
Key inclusion criteria (5 listed)
- Age ≥ 18 years,
- Outpatient or hospitalized for any health-related reason,
- Oral and written proficiency in French,
- Patient informed and willing to participate in the study,
- Patient with health insurance coverage
Key exclusion criteria (2 listed)
- Individuals under legal protection measures (guardianship, conservatorship, or legal supervision),
- Other factors preventing obtaining non-opposition or conducting the research, such as: limited French proficiency, hearing impairment, or significant cognitive disorders
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
Assess the validity of the French version of the PHQ-4 (Patient Health Questionnaire-4 ) scale
Time frame: 14 days
This scale is used for the screening of anxiety and depression. The scale will be scored. Score ranging from 0 to 12, corresponding to four levels of psychological distress: * None: 0-2 * Mild: 3-5 * Moderate: 6-8 * Severe: 9-12 Patients will complete this scale at Visit 1 and Visit 2.
Assess the validity of the French version of the PC-TDSD-5 (Primary Care PTSD Screen for DSM-5) scale
Time frame: 14 days
Scale assessing whether the patient has experienced unusually or particularly frightening, horrible, or traumatic events. Examples include: * A serious accident or fire * Physical or sexual assault, or sexual abuse * An earthquake or flood * War * Witnessing a person being killed or seriously injured * The death of a close person by homicide or suicide Total score = sum of "YES" responses to questions 1 through 5. Patients will complete this scale at Visit 1 and Visit 2.
1 secondary outcome
Assess the feasibility of this screening tool during the first evaluation visit.
Time frame: At Visit 1 (at inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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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.
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 Mental Illness, run by Assistance Publique - Hôpitaux de Paris 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 5 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladimir ADRIEN, Doctor ((+33) 1 48 95 59 37, vladimir.adrien@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the validity of the French version of the PHQ-4 (Patient Health Questionnaire-4 ) scale (time frame: 14 days). The study lists 2 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 9 Feb 2026.