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

Validation of the French Versions of the PHQ-4 Anxiety and Depression Scale and the PC-PTSD-5 Post-Traumatic Stress Disorder Screening Scale

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07396623
Acronym
DEPSYSTAGE
Enrollment
90
Registered
2026-02-09
Start date
2026-01-26
Completion date
2027-08-15
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Illness

Keywords

Post-Traumatic Stress Disorder, Depression, Anxiety, Screening tool

Brief 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. 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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assess the validity of the French version of the PHQ-4 (Patient Health Questionnaire-4 ) scale14 daysThis 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) scale14 daysScale 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.

Secondary

MeasureTime frameDescription
Assess the feasibility of this screening tool during the first evaluation visit.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).

Countries

France

Contacts

CONTACTVladimir ADRIEN, Doctor
vladimir.adrien@aphp.fr(+33) 1 48 95 59 37

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026