A One-year Trajectory of Depression Status Changes in Elderly Patients With MCI and SD: a Longitudinal Cohort Study

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

The purpose of this study is to investigate the one-year trajectory of changes in depression status in elderly patients 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 the elderly, 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 (subliminal 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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Older Adults; Subthreshold Depression

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Hong Li; Phone Number: 18120826271; Email: leehong99@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • Fujian Provincial Hospital
      • Contact: Hong Li; Phone Number: 18120826271; Email: leehong99@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Select elderly patients with mild cognitive impairment and subthreshold depression who meet the inclusion and exclusion criteria from multiple elderly care institutions, a tertiary hospital in Fuzhou, and communities in Fujian Province as the research subjects.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive state	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.	2023.6.1-2024.7.1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General information of patients	Using a self-made general information scale, such as age, gender, education level, and other basic personal information	2023.6.1-2024.7.1
Cognitive	The Mini Mental State Examination (MMSE) consists of 30 items, with a total score range of 0-30 points. A total score below 27 indicates cognitive impairment. The diagnostic criteria for dementia are illiteracy ≤ 17 points, primary school level ≤ 20 points, secondary school level (including vocational school) ≤ 22 points, and university level (including vocational school) ≤ 23 points.	2023.6.1-2024.7.1
Cognitive	Montreal Cognitive Assessment (MoCA) is an assessment tool used for rapid screening of mild cognitive impairment. The total score is 30 points, and the higher the score, the better the cognitive function of the research subject. Literacy group ≤ 13 points, primary school group ≤ 19 points, and middle school and above group ≤ 24 points can be judged as cognitive impairment.	2023.6.1-2024.7.1
Activity of Daily Living	The Activities of Daily Living (ADL) scale adopts a Liket four level rating. The evaluation results can be analyzed based on total score, dimension score, and individual score. A total score of 20 is considered completely normal, while a score above 20 indicates varying degrees of functional decline. A score of 1 for each item indicates normal functionality, while a score of 2-4 indicates decreased functionality.	2023.6.1-2024.7.1
Anxiety	The Self Rating Anxiety Scale (SAS) has a total of 20 items, of which 5, 9, 13, 17, and 19 items are scored in reverse. The scale adopts a 1-4 level scoring method (1 point for no or very little time; 2 points for a small portion of time; 3 points for a considerable amount of time; 4 points for the vast majority or all of time). Individuals fill in the scale based on their own situation in the most recent week, multiply the calculated total score by 1.25, take an integer as the standard score, and use it as a statistical indicator. The higher the standard score, the more severe the anxiety level of the individual.	2023.6.1-2024.7.1
Social Function	The Social Support Rating Scale (SSRS) includes three dimensions: objective support, subjective support, and support utilization, with a total of 10 items: 1 point (none) to 4 points (full support). The higher the score in each dimension, the more support received.	2023.6.1-2024.7.1
Social Function	The Lubben Social Network Scale (LSNS-6) is used to measure the structural characteristics of individual family and friend networks, as well as the supporting functions played by the network, in order to reflect the social network level of the respondents. It consists of two parts: the home network and the friend network, each with three items, totaling six items. Each entry has 5 options, with a score of 0-5 points and a total score of 0-30 points. The higher the score, the higher the level of social network, and<12 points indicates insufficient social network.	2023.6.1-2024.7.1
Sleep Quality	The Pittsburgh Sleep Quality Index (PSQI) has a total of 19 items, divided into 7 components: subjective sleep quality, time to fall asleep, sleep time, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function. The higher the total score, the worse the sleep quality.	2023.6.1-2024.7.1
Resilience	The Corner Davidson Resilience Scale (CDRISC) consists of 10 items and uses the Likert 5-point scoring system. A score of 0-4 indicates "never", "rarely", "sometimes", "often", and "always", with higher scores indicating higher levels of psychological resilience.	2023.6.1-2024.7.1

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: DanTing Chen, Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Older adults; Subthreshold Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neurocognitive Disorders; Cognition Disorders; Depression; Depressive Disorder; Cognitive Dysfunction
• Other Study ID Numbers: K2022-03-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No