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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Mediterranean diet lessons program
  • Physical activity

Treatment groups

120 Participants
are divided into 2 treatment groups