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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• MADR Scale for Depression [Срок оценки: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).]
• Beck Depression Inventory - II [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).]

Вторичные конечные точки (2)

• Immunitary-related factors levels [Срок оценки: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).]
• Gut Microbiome Composition [Срок оценки: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• IRCCS Centro San Giovanni fi Dio Fatebenefratelli — Brescia

Идентификаторы

NCT: NCT06990035 · 5M-2022-23685026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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