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

Not Applicable

Not yet recruiting

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT06990035
• Lead Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-07
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MADR Scale for Depression	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.
Beck Depression Inventory - II	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.
Zung Self-Rating Depression Scale	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
Personal and Social Performance Scale	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.
World Health Organization Quality of Life - Bref	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 Outcome Measures

Name	Time	Method
Gut Microbiome Composition	Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).
Immunitary-related factors levels	Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).	Plasma/serum levels of cytokines

Trial Locations

Locations (1)

IRCCS Centro San Giovanni fi Dio Fatebenefratelli; 🇮🇹 Brescia, Italy