Symptoms of anxiety and/or depression Mental and Behavioural Disorders
Conditions
Interventions
At baseline (t0), participants will undergo a clinical psychiatric interview to determine eligibility for inclusion in the study according to predefined inclusion and exclusion criteria. Demographic a
Sponsors
University General Hospital Attikon
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. A score =8 on the Hospital Anxiety and Depression Scale–Depression (HADS-D) and/or the Hospital Anxiety and Depression Scale–Anxiety (HADS-A) 2. Ages 18-85 3. Patients who attended the Cardiology, Gastroenterology, or Dermatology Outpatient Clinics of the University General Hospital “Attikon”
Exclusion criteria
Exclusion criteria: 1. Patients were excluded if they did not meet the symptom severity threshold (HADS-D <8 and HADS-A <8) 2. Younger than 18 or older than 85 years 3. Current or past psychiatric disorder diagnosis, including schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, other mood disorders, eating disorders, or substance-related and addictive disorders, as defined by the DSM-5 4. Presence of major gastrointestinal disorders at enrollment according to ICD-10 codes K50–K52 and K55–K64 (16,17) 5. Pregnancy within two months prior to enrollment 6. Lactation at the time of enrollment 7. Exposure within the preceding six months to psychotropic medications (ATC codes N03, N05, N06), immunomodulatory or antineoplastic agents (ATC codes L01, L03, L04), or within the preceding three months to antibiotics, antifungal, antimycobacterial, or antiviral agents, immune sera, or immunoglobulins (ATC codes J01, J02, J04, J05, J06) 8. Diagnosis of any active infection within one month prior to enrollment, a confirmed SARS-CoV-2 infection within 35 days prior to enrollment 9. Patients who had a clinical indication for initiation of antidepressant or anxiolytic pharmacotherapy at the time of enrollment or had initiated psychotherapy within the 12 weeks preceding or at the time of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety symptomatology measured using the Hospital Anxiety and Depression Scale–Anxiety (HADS-A) at t0 (baseline) and t1 (3 months);Depressive symptomatology measured using the Hospital Anxiety and Depression Scale–Depression (HADS-D) at t0 (baseline) and t1 (3 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Whole blood/serum concentrations of inflammatory and neurotrophic biomarkers, including C-reactive protein (CRP), brain-derived neurotrophic factor (BDNF), tumour necrosis factor-alpha (TNF-a), and interleukin-6 (IL-6), measured using enzyme-linked immunosorbent assay (ELISA) at t0 (baseline) and t1 (3 months) | — |
Countries
Greece
Contacts
Public ContactMarina Demetriou
Outcome results
None listed