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Recruiting NCT07009223

Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice

No phase Interventional Major Depressive Disorder (MDD) Physical Activity Inflammation Metabolome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mediterranean Diet, Physical Activity, Cognitive Training.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD), Physical Activity, Inflammation, Metabolome. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice

Overview

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.

Interventions

  • Behavioral Mediterranean Diet
    Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.
  • Behavioral Physical Activity
    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.
  • Behavioral Cognitive Training
    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.

Primary outcome measures

  • MADR Scale for Depression [Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • PHQ-9 [Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • GDS-15 [Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • WHOQOL-BREF [Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • RBANS [Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • TMT [Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • DSST [Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • M-WCST [Time frame: Baseline, Week 12, and 3-month follow-up (Week 24)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Italy · 1 center
  • IRCCS Centro San Giovanni di Dio Fatebenefratelli — Brescia

Identifiers

NCT: NCT07009223 · CERP-2024-23685718

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗