Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression

Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato

This clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention.

Participants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.

Inclusion Criteria:

• Primary diagnosis of depression (DSM-5 criteria, American Psychiatric Association 2013).
• Depressive symptoms assessed using MADR, BDI, or ZDR scales.
• Ability to provide written informed consent.
• Self-reported moderate-intensity leisure physical activity of less than 150 minutes per week.

Exclusion Criteria:

• Patients with severe psychopathology.
• Medical contraindications to physical activity.
• Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant.
• Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months
• Active gastrointestinal diseases
• Autoimmune and/or chronic inflammatory disorders