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

Launched by IRCCS CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a combination of learning about the Mediterranean diet and engaging in physical activity can help reduce symptoms of major depressive disorder (MDD). The Mediterranean diet is known for its health benefits and includes foods like fruits, vegetables, whole grains, and healthy fats. Participants will be divided into two groups: one group will receive education on the diet, while the other group will get the same dietary lessons along with a structured 12-week exercise program. The researchers will also study how these interventions may affect the body’s biology, such as changes in gut health and inflammation.

To be eligible for this trial, participants must have a primary diagnosis of depression and report doing less than 150 minutes of moderate-intensity physical activity each week. They should also be able to give their written consent to join the study. However, those with severe mental health issues, certain medical conditions, or recent treatments that could affect their health won't be able to participate. The trial is not yet recruiting, so interested individuals will need to wait for further announcements. Overall, this study aims to find effective ways to support people dealing with depression by promoting healthier lifestyles.

Gender

ALL

Eligibility criteria

• 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