Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- WHOQOL-BREF
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 3: CON + Cognitive training
干预措施: Mediterranean Diet (Behavioral)
Group 3: CON + Cognitive training
干预措施: Cognitive Training (Behavioral)
Group 1: Control group (CON)
干预措施: Mediterranean Diet (Behavioral)
Group 2: CON + physical activity
干预措施: Mediterranean Diet (Behavioral)
Group 2: CON + physical activity
干预措施: Physical Activity (Behavioral)
结局指标
主要结局
WHOQOL-BREF
时间窗: Baseline, Week 12, and 3-month follow-up (Week 24)
The World Health Organization Quality of Life - Bref (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.
MADR Scale for Depression
时间窗: Baseline, Week 12, and 3-month follow-up (Week 24)
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.
PHQ-9
时间窗: Baseline, Week 12, and 3-month follow-up (Week 24)
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered instrument used to assess the severity of depressive symptoms based on DSM criteria. It consists of 9 items, each rated from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 27. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.
GDS-15
时间窗: Baseline, Week 12, and 3-month follow-up (Week 24)
The Geriatric Depression Scale - Short Form (GDS-15) is a self-report questionnaire designed to screen for depressive symptoms in older adults. It contains 15 yes/no items, with a total score ranging from 0 to 15. Higher scores indicate more severe depressive symptoms, representing a worse clinical outcome.
RBANS
时间窗: Baseline, Week 12, and 3-month follow-up (Week 24)
The Repeatable Battery for the Assessment of Neuropsychological (RBANS) is a neuropsychological battery composed of 12 subtests grouped into five domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. It yields index scores and a total scale score. Higher scores indicate better cognitive functioning, reflecting a more favorable clinical outcome.
TMT
时间窗: Baseline, Week 12, and 3-month follow-up (Week 24)
The Trail Making Test (TMT) evaluates processing speed (Part A) and executive function, including task switching (Part B). The outcome is the time (in seconds) required to complete each part. Lower completion times indicate better performance and cognitive flexibility.
DSST
时间窗: Baseline, Week 12, and 3-month follow-up (Week 24)
The Digit Symbol Substitution Test (DSST) evaluates attention, processing speed, and working memory. Participants match numbers and symbols in a limited time. Higher scores reflect better performance.
M-WCST
时间窗: Baseline, Week 12, and 3-month follow-up (Week 24)
The Modified Wisconsin Card Sorting (M-WCST) measures cognitive flexibility and executive function. Outcomes include number of categories completed and perseverative errors. More categories and fewer errors indicate better performance.
次要结局
- Immunitary-related factors levels(Baseline, Week 12, and 3-month follow-up (Week 24))
- Gut Microbiome Composition(Baseline, Week 12, and 3-month follow-up (Week 24))