Clinical trial NCT06308627: A One-year Trajectory of Depression Status Changes in Older Adults With MCI and SD: a Longitudinal Cohort Study
Official title: A One-year Trajectory of Depression Status Changes in Older Adults With Mild Cognitive Impairment and Subthreshold Depression: a Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Subthreshold Depression
Older Adults
Keywords: Mild Cognitive Impairment
Subthreshold Depression
Older adults
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 466
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Depressive state
timeFrame: 2023.6.1-2024.7.1
Secondary outcomes:
measure: General information of patients
timeFrame: 2023.6.1-2024.7.1
measure: Cognitive
timeFrame: 2023.6.1-2024.7.1
measure: Activity of Daily Living
timeFrame: 2023.6.1-2024.7.1
measure: Anxiety
timeFrame: 2023.6.1-2024.7.1
measure: Social Function
timeFrame: 2023.6.1-2024.7.1
measure: Social Function
timeFrame: 2023.6.1-2024.7.1
measure: Sleep Quality
timeFrame: 2023.6.1-2024.7.1
measure: Resilience
timeFrame: 2023.6.1-2024.7.1
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian provincial hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University
name: DanTing Chen
role: PRINCIPAL_INVESTIGATOR
References: