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NCT Number: NCT06990035

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

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Behavior Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Motor Activity

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro San Giovanni fi Dio Fatebenefratelli

Brescia, 25125, Italy

Location contact

Annamaria Cattaneo, PhD

CONTACT

[email protected]

030 3501599

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean diet lessons program

Behavioral

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.

Physical activity

Behavioral

Participants will undergo a 12-week physical exercise program guided by specified personal trainers.

Primary outcomes

  1. 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).

    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.

  2. 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).

    The Beck Depression Inventory (BDI) is a self-report questionnaire used to assess the presence and severity of depressive symptoms. It comprises 21 items, each rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 63. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.

  3. 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).

    The Zung Self-Rating Depression Scale (ZRS) is a self-administered questionnaire designed to assess the level of depressive symptoms in individuals. It consists of 20 items, each rated on a scale from 1 to 4, based on how often symptoms are experienced. The raw total score ranges from 20 to 80, which is often converted to an index score (ranging from 25 to 100) by multiplying the raw score by 1.25. Higher scores indicate more severe depression

  4. 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).

    The Personal and Social Performance Scale (PSP) is a clinician-rated instrument used to assess personal and social functioning in individuals with mental disorders. The total score ranges from 1 to 100, with higher scores indicating better functioning and a more favorable clinical outcome.

  5. 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).

    The 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.

Secondary outcomes

  1. Immunitary-related factors levels

    Time frame: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).

    Plasma/serum levels of cytokines

  2. Gut Microbiome Composition

    Time frame: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).

Study contacts

Contact information is provided by the study sponsor or research team.

Annamaria Cattaneo, PhD

CONTACT

[email protected]

0039 030 3501599

Sponsors and collaborators

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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