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临床试验/NCT06308627
NCT06308627已完成不适用

A One-year Trajectory of Depression Status Changes in Older Adults With Mild Cognitive Impairment and Subthreshold Depression: a Longitudinal Cohort Study

Fujian Medical University1 个研究点 分布在 1 个国家目标入组 466 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
466
试验地点
1
主要终点
Depressive state

研究概览

简要总结

The purpose of this study is to investigate the one-year trajectory of changes in depression status in older adults with mild cognitive impairment and subthreshold depression, and to explore relevant risk factors for predicting changes in depression status. This one-year prospective longitudinal follow-up study involved 400 (expected) subjects who met the diagnostic criteria for mild cognitive impairment combined with subthreshold depression in older adults, and their depressive status was assessed using the Geriatric Depression Scale (GDS). Follow up monitoring of depression status at 6 and 12 months. Obtain factors related to changes in depressive status (such as age, gender, education level, cognitive function, anxiety level, sleep status, social support, psychological resilience, social network, etc.). By studying the longitudinal trajectory of depression status in elderly patients with mild cognitive impairment and subthreshold depression, a multi state Markov model with time and state discreteness is constructed, namely: State 1 (normal); State 2 (subthreshold depression); State 3 (mild depression); State 4 (moderate depression); State 5 (severe depression). Deeply explore and analyze the impact of certain factors and indicators on the transition between states, and estimate the probability of transition between states.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age: ≥ 60 years old
  • •Meets the diagnostic criteria for mild cognitive impairment and subthreshold depression
  • •Having basic comprehension and verbal expression skills
  • •Voluntarily participate in this study and sign an informed consent form.

排除标准

  • •Diagnosed as depression patients, including patients with organic mental disorders and patients with a history of depression related mental disorders
  • •Cognitive impairment caused by other diseases (such as neurological and psychiatric disorders, metabolic disorders, poisoning, infections, etc.)
  • •Severe heart, liver, and kidney diseases
  • •Serious chronic diseases and complications, such as congestive heart failure, hypertension, diabetes and other diseases with serious complications

结局指标

主要结局

Depressive state

时间窗: 2023.6.1-2024.7.1

The Geriatric Depression Scale (GDS-15) is used to investigate the psychological feelings of patients in the past week. Result evaluation criteria: The total score range is 0-15 points, with higher scores indicating more severe depression. 1-5 points are subthreshold depression, 6-7 points are mild depression, 8-11 points are moderate depression, and 12-15 points are severe depression.

次要结局

  • Social Function(2023.6.1-2024.7.1)
  • Resilience(2023.6.1-2024.7.1)
  • General information of patients(2023.6.1-2024.7.1)
  • Cognitive(2023.6.1-2024.7.1)
  • Activity of Daily Living(2023.6.1-2024.7.1)
  • Anxiety(2023.6.1-2024.7.1)
  • Sleep Quality(2023.6.1-2024.7.1)

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan Ting Chen

Principal Investigator

Fujian Medical University

研究点 (1)

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