Major Depressive Disorder (MDD)POWERNCT07009223
Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice
A study testing Mediterranean Diet, Physical Activity and Cognitive Training in people with Major Depressive Disorder (MDD) and Physical Activity, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Physical Activity, Inflammation
- What is being tested?
- Mediterranean Diet, Physical Activity and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 50 and 80 years;
- Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age);
- Ability to provide written informed consent.
Who cannot join
- Active gastrointestinal disorders;
- Autoimmune disorders;
- Chronic inflammatory disorders;
- Diagnosis of dementia; cognitive impairment or mild functional impairment.
- Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125
Annamaria Cattaneo, PhD, acattaneo@fatebenefratelli.eu
About this study
Official title: Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice
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:
Read more
- Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms?
- Does cognitive training help prevent mental difficulties in people at risk of cognitive decline?
- Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors?
Researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health.
The participants:
- Will take part to online sessions on healthy eating based on the Mediterranean diet
- Some will do regular exercise, supervised by a personal trainer
- Others will do weekly cognitive training in small groups at the hospital
- They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.
- Conditions
- Major Depressive Disorder (MDD), Physical Activity, Inflammation, Metabolome, Gut Microbiota, Depressive Symptoms
- Being tested
- Mediterranean Diet, Physical Activity, Cognitive Training
- Keywords
- Depression, Cognition, nutrition
- Medical subject headings
- Depressive Disorder, Major, Motor Activity, Inflammation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.
Physical ActivityBehavioural
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.
Cognitive TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Control group (CON) | Active comparator | Not described Receives: Behavioral: Mediterranean Diet |
| Group 2: CON + physical activity | Experimental | Not described Receives: Behavioral: Mediterranean Diet; Behavioral: Physical Activity |
| Group 3: CON + Cognitive training | Experimental | Not described Receives: Behavioral: Mediterranean Diet; Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and 3-month follow-up (Week 24)
Secondary outcomes (2)
Immunitary-related factors levels
Plasma/serum levels of cytokines
Measured: Baseline, Week 12, and 3-month follow-up (Week 24)
Gut Microbiome Composition
Measured: Baseline, Week 12, and 3-month follow-up (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Oct 2025
- Primary completionAug 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), University of Milan, China Medical University, China, University College Cork, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009223
- Sponsor's protocol ID
- CERP-2024-23685718
- Acronym
- POWER
- Status last verified
- Feb 2026
- First submitted
- 19 May 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice
- ClinicalTrials.gov ID
- NCT07009223
- Acronym / sponsor ID
- POWER / CERP-2024-23685718
- Conditions
- Major Depressive Disorder (MDD), Physical Activity, Inflammation, Metabolome, Gut Microbiota, Depressive Symptoms
- Keywords
- Depression, Cognition, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), University of Milan, China Medical University, China, University College Cork, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms?
- Does cognitive training help prevent mental difficulties in people at risk of cognitive decline?
- Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors?
Researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health.
The participants:
- Will take part to online sessions on healthy eating based on the Mediterranean diet
- Some will do regular exercise, supervised by a personal trainer
- Others will do weekly cognitive training in small groups at the hospital
- They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control group (CON) | Active comparator | Behavioral: Mediterranean Diet |
| Group 2: CON + physical activity | Experimental | Behavioral: Mediterranean Diet, Behavioral: Physical Activity |
| Group 3: CON + Cognitive training | Experimental | Behavioral: Mediterranean Diet, Behavioral: Cognitive Training |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 50 and 80 years;
- Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age);
- Ability to provide written informed consent.
Key exclusion criteria (5 listed)
- Active gastrointestinal disorders;
- Autoimmune disorders;
- Chronic inflammatory disorders;
- Diagnosis of dementia; cognitive impairment or mild functional impairment.
- Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietParticipants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist. | Behavioural | Group 1: Control group (CON), Group 2: CON + physical activity, Group 3: CON + Cognitive training |
| Physical ActivityIn 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. | Behavioural | Group 2: CON + physical activity |
| Cognitive TrainingIn 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. | Behavioural | Group 3: CON + Cognitive training |
Primary outcome
MADR Scale for Depression
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
PHQ-9
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
GDS-15
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
WHOQOL-BREF
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
RBANS
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
TMT
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
DSST
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
M-WCST
Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
2 secondary outcomes
Immunitary-related factors levels
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet, Physical Activity and Cognitive Training in people with Major Depressive Disorder (MDD) and Physical Activity, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Mombelli ((+39) 030 35 01 598, emombelli@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADR Scale for Depression (time frame: Baseline, Week 12, and 3-month follow-up (Week 24)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.