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

NCT06308627 | Completed DMC

• 1 other identifier: K2022-03-074
• Study Type: observational
• Target: 466
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Subthreshold Depression; Older Adults

Keywords

Mild Cognitive Impairment; Subthreshold Depression; Older adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Social Function

  2023.6.1-2024.7.1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian provincial hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• DanTing Chen

  Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 13, 2024
• Study Start: June 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)