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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.
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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Visit 1 (at inclusion) |
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Inclusion Criteria:
Exclusion Criteria:
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This study will involve adult patients, regardless of sex, who present for consultation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir ADRIEN, Doctor | Contact | (+33) 1 48 95 59 37 | vladimir.adrien@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne | Recruiting | Bobigny | 93000 | France |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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