Mild Cognitive ImpairmentNCT06308627
A One-year Trajectory of Depression Status Changes in Older Adults With MCI and SD: a Longitudinal Cohort Study
An observational study of Mild Cognitive Impairment and Subthreshold Depression, run by Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Subthreshold Depression, Older Adults
- How many people
- 466 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Keywords
- Mild Cognitive Impairment, Subthreshold Depression, Older adults
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2023.6.1-2024.7.1
Secondary outcomes (8)
General information of patients
Using a self-made general information scale, such as age, gender, education level, and other basic personal information
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2023.6.1-2024.7.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Jun 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Ting Chen, Fujian Medical University
- Investigators
- DanTing Chen, Principal investigator, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308627
- Sponsor's protocol ID
- K2022-03-074
- Status last verified
- Nov 2024
- First submitted
- 4 Mar 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-year Trajectory of Depression Status Changes in Older Adults With Mild Cognitive Impairment and Subthreshold Depression: a Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT06308627
- Acronym / sponsor ID
- K2022-03-074
- Keywords
- Mild Cognitive Impairment, Subthreshold Depression, Older adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depressive state
Time frame: 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.
8 secondary outcomes
General information of patients
Time frame: 2023.6.1-2024.7.1
Cognitive
Time frame: 2023.6.1-2024.7.1
Activity of Daily Living
Time frame: 2023.6.1-2024.7.1
Anxiety
Time frame: 2023.6.1-2024.7.1
Social Function
Time frame: 2023.6.1-2024.7.1
Social Function
Time frame: 2023.6.1-2024.7.1
Sleep Quality
Time frame: 2023.6.1-2024.7.1
Resilience
Time frame: 2023.6.1-2024.7.1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DanTing Chen principal investigator
Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Subthreshold Depression, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive state (time frame: 2023.6.1-2024.7.1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.