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Идёт набор NCT07009223

Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice

Без фазы С лечением Major Depressive Disorder (MDD) Physical Activity Inflammation Metabolome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mediterranean Diet, Physical Activity, Cognitive Training.
Кому может быть актуально
Состояния в реестре: Major Depressive Disorder (MDD), Physical Activity, Inflammation, Metabolome. Базовые параметры: 50 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice

Обзор

The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline. The main questions it aims to answer are: * Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms? * Does cognitive training help prevent mental difficulties in people at risk of cognitive decline? * Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors? Researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health. The participants: * Will take part to online sessions on healthy eating based on the Mediterranean diet * Some will do regular exercise, supervised by a personal trainer * Others will do weekly cognitive training in small groups at the hospital * They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.

Вмешательства

  • Поведенческое Mediterranean Diet
    Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.
  • Поведенческое Physical Activity
    In addition to educational sessions on the Mediterranean diet, there will be 2-3 weekly personalized exercise sessions, followed by a dedicated personal trainer at a partner gym. The treatment will last 12 weeks.
  • Поведенческое Cognitive Training
    In addition to educational sessions on the Mediterranean diet, there will be one weekly cognitive training session in groups, supervised by qualified staff at the IRCCS FBF. The treatment will last for 12 weeks.

Первичные конечные точки

  • MADR Scale for Depression [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • PHQ-9 [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • GDS-15 [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • WHOQOL-BREF [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • RBANS [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • TMT [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • DSST [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • M-WCST [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
Вторичные конечные точки (2)
  • Immunitary-related factors levels [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]
  • Gut Microbiome Composition [Срок оценки: Baseline, Week 12, and 3-month follow-up (Week 24)]

Критерии участия

Критерии включения

  • Aged between 50 and 80 years;
  • Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age);
  • Ability to provide written informed consent.

Критерии исключения

  • Active gastrointestinal disorders;
  • Autoimmune disorders;
  • Chronic inflammatory disorders;
  • Diagnosis of dementia; cognitive impairment or mild functional impairment.
  • Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Италия · 1 центр
  • IRCCS Centro San Giovanni di Dio Fatebenefratelli — Brescia

Идентификаторы

NCT: NCT07009223 · CERP-2024-23685718

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗