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

NCT06990035 | Not Yet Recruiting

• 1 other identifier: 5M-2022-23685026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major depressive disorder; Physical activity; Mediterranean Diet; Microbiome

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).

• Beck Depression Inventory - II

  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.

  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

  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

  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

  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.

  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

  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.

  Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).

Secondary Outcomes (2)

• Immunitary-related factors levels

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

• Gut Microbiome Composition

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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Mediterranean diet lessons program

Behavioral: Mediterranean diet lessons program

Experimental Group

EXPERIMENTAL

Physical activity program

Behavioral: Mediterranean diet lessons program; Behavioral: Physical activity

Interventions

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.

Control Group; Experimental Group

Physical activity BEHAVIORAL

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

Experimental Group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (1)

IRCCS Centro San Giovanni fi Dio Fatebenefratelli

Brescia, 25125, Italy

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Annamaria Cattaneo, PhD

CONTACT

0039 030 3501599; acattaneo@fatebenefratelli.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 25, 2025
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-03

Locations

IT (1)