An interventional study of Mediterranean Diet and Physical Activity in Major Depressive Disorder (MDD), Physical Activity and Inflammation, sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruiting at 1 site in Italy. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Not applicable, Interventional, and Prevention
The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline.
The main questions it aims to answer are:
Researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health.
The participants:
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 120 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →IRCCS Centro San Giovanni di Dio Fatebenefratelli is the lead sponsor of 36 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Mediterranean Diet
Behavioral: Mediterranean Diet · Behavioral: Physical Activity
Behavioral: Mediterranean Diet · Behavioral: Cognitive Training
Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.
In addition to educational sessions on the Mediterranean diet, there will be 2-3 weekly personalized exercise sessions, followed by a dedicated personal trainer at a partner gym. The treatment will last 12 weeks.
In addition to educational sessions on the Mediterranean diet, there will be one weekly cognitive training session in groups, supervised by qualified staff at the IRCCS FBF. The treatment will last for 12 weeks.
MADR Scale for Depression
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to assess the severity of depressive symptoms. It consists of 10 items, each rated on a scale from 0 to 6, yielding a total score ranging from 0 to 60. Higher scores indicate greater severity of depression, meaning a worse clinical outcome.
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered instrument used to assess the severity of depressive symptoms based on DSM criteria. It consists of 9 items, each rated from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 27. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
GDS-15
The Geriatric Depression Scale - Short Form (GDS-15) is a self-report questionnaire designed to screen for depressive symptoms in older adults. It contains 15 yes/no items, with a total score ranging from 0 to 15. Higher scores indicate more severe depressive symptoms, representing a worse clinical outcome.
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
WHOQOL-BREF
The World Health Organization Quality of Life - Bref (WHOQOL-BREF) is a self-report questionnaire developed by the WHO to assess quality of life across multiple domains. It contains 26 items rated on a 5-point Likert scale. Higher scores indicate a better quality of life, reflecting a more favorable outcome.
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
RBANS
The Repeatable Battery for the Assessment of Neuropsychological (RBANS) is a neuropsychological battery composed of 12 subtests grouped into five domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. It yields index scores and a total scale score. Higher scores indicate better cognitive functioning, reflecting a more favorable clinical outcome.
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
TMT
The Trail Making Test (TMT) evaluates processing speed (Part A) and executive function, including task switching (Part B). The outcome is the time (in seconds) required to complete each part. Lower completion times indicate better performance and cognitive flexibility.
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
DSST
The Digit Symbol Substitution Test (DSST) evaluates attention, processing speed, and working memory. Participants match numbers and symbols in a limited time. Higher scores reflect better performance.
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
M-WCST
The Modified Wisconsin Card Sorting (M-WCST) measures cognitive flexibility and executive function. Outcomes include number of categories completed and perseverative errors. More categories and fewer errors indicate better performance.
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
Immunitary-related factors levels
Plasma/serum levels of cytokines
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
Gut Microbiome Composition
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
IRCCS Centro San Giovanni di Dio Fatebenefratelli