Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Conditions:

Major Depressive Disorder (MDD)

Eligibility:

All Genders

55-80 years

Phase:

NA

Brief Summary

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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06990035

Start Date

July 1 2025

End Date

February 1 2026

Last Update

May 25 2025

Active Locations (1)

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IRCCS Centro San Giovanni fi Dio Fatebenefratelli

Brescia, Italy, 25125