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Not yet recruiting NCT06990035

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

No phase Interventional Major Depressive Disorder (MDD)

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 lessons program, Physical activity.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD). Basic parameters: 55 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

Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato

Overview

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 individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention. Participants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.

Interventions

  • Behavioral Mediterranean diet lessons program
    Participants will attend five one-hour lessons delivered by qualified professionals to learn about foods that have a positive impact on cognitive function and how to incorporate them into their dietary regimen.
  • Behavioral Physical activity
    Participants will undergo a 12-week physical exercise program guided by specified personal trainers.

Primary outcome measures

  • MADR Scale for Depression [Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).]
  • Beck Depression Inventory - II [Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).]
  • Zung Self-Rating Depression Scale [Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).]
  • Personal and Social Performance Scale [Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).]
  • World Health Organization Quality of Life - Bref [Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).]
Secondary outcome measures (2)
  • Immunitary-related factors levels [Time frame: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).]
  • Gut Microbiome Composition [Time frame: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).]

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

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
Single blind
Primary purpose
Supportive care

Study locations

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

Identifiers

NCT: NCT06990035 · 5M-2022-23685026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗