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

NCT07396623 | Recruiting

• 1 other identifier: APHP250750
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Illness

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  14 days

Secondary Outcomes (1)

• Assess the feasibility of this screening tool during the first evaluation visit.

  At Visit 1 (at inclusion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Vladimir ADRIEN, Doctor

CONTACT

(+33) 1 48 95 59 37; vladimir.adrien@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 554 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)