Validation of French PHQ-4 and PC-PTSD-5 Screening Scales (DEPSYSTAGE)

February 2, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bobigny, France, 93000
        • Recruiting
        • Hôpital Avicenne
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vladimir Adrien, Doctor
        • Principal Investigator:
          • Nicolas Vignier, Professor
        • Principal Investigator:
          • Gaëlle Colevray, Medical student
        • Principal Investigator:
          • Anne Mottais, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will involve adult patients, regardless of sex, who present for consultation.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the feasibility of this screening tool during the first evaluation visit.
Time Frame: At Visit 1 (at inclusion)
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).
At Visit 1 (at inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

August 15, 2027

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP250750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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