2026 FEB 20 (NewsRx) — By a News Reporter-Staff News Editor at Health Policy and Law Daily — Staff editors report on the newly launched clinical trial, NCT07396623, which has the following summary description: “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.”
As a matter of record, on February 10, 2026, NewsRx staff editors report that the available information provided by Assistance Publique – Hopitaux de Paris on this trial include:
Tracking Information
Trial Identifier
NCT07396623
First Submitted Date
February 2, 2026
First Posted Date
February 9, 2026
Results First Submitted Date
Not Provided
Results First Posted Date
Not Provided
Last Update Submitted Date
February 2, 2026
Last Update Posted Date
February 9, 2026
Primary Completion Date
August 15, 2027
Start Date
2026-01-26
Current Primary Outcome Measures
•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.
Current Secondary Outcome Measures
•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).
Other Outcome Measures
Not Provided
Change History
Complete list of historical revisions of study NCT07396623
Descriptive Information
Brief Title
Validation of French PHQ-4 and PC-PTSD-5 Screening Scales
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
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.
Study Type
OBSERVATIONAL
Study Phase
Not Provided
Study Design
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Follow-Up Duration
554 Days
Condition
Mental Illness
Intervention
Not Provided
Study Arms
Not Provided
Recruitment Information
Recruitment Status
RECRUITING
Enrollment
90
Completion Date
2027-08-15
Primary Completion Date
August 15, 2027 (Final data collection date for primary outcome measure)
Eligibility
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
Sex/Gender
Sexes Eligible for Study: ALL
Ages
18 years to
Accepts Healthy Volunteers
f
Contacts
Primary contact: Vladimir ADRIEN, Doctor, (+33) 1 48 95 59 37, [email protected]
Listed Location Countries
France
Removed Location Countries
Administrative Information
NCT Number
NCT07396623
Other Study ID Numbers
APHP250750
Has Data Monitoring Committee
Not Provided
U.S. FDA-regulated Product
Not Provided
Plan to Share Data (IPD) Description
Not Provided
Collaborators
Not Provided
Investigators
Not Provided
Information Provided By
Assistance Publique – Hopitaux de Paris
Verification Date
2026-01
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