Mild Cognitive ImpairmentNCT06706739
A Trial of Combined Subthreshold Depression in Older Adults With Mild Cognitive Impairment Participating in Art Games
A study testing Online art game intervention group in people with Mild Cognitive Impairment and Subthreshold Depression, run by Fujian Medical University at 1 site in China.
Trial summary
The presence of subthreshold depression accelerates quality of life decline and cognitive impairment in older adults with mild cognitive impairment, increasing the rate of dementia conversion, while the continuous decline in cognitive function, in turn, accelerates the deterioration of depression. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Subthreshold Depression
- What is being tested?
- Online art game intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 30 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥60 years old;
- Meet the diagnostic criteria of mild cognitive impairment and subthreshold depression;
- Possess basic comprehension and verbal expression ability; Voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Patients who have been diagnosed with depression, including patients with organic mental disorders and patients with previous history of depression-related mental disorders;
- Patients with cognitive disorders caused by other diseases (e.g. neurological and psychiatric diseases, metabolic disorders, poisoning, infections, etc.);
- Patients with severe cardiac, hepatic, and renal diseases;
- Patients with severe chronic diseases and comorbidities, such as patients with congestive heart failure and patients with hypertension and diabetes mellitus, etc., who suffer from severe complications.
- Patients with serious chronic diseases and comorbidities, such as congestive heart failure, hypertension, diabetes and other diseases combined with serious complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Combined Subthreshold Depression in Older Adults With Mild Cognitive Impairment Participating in Online Art Games
The presence of subthreshold depression accelerates quality of life decline and cognitive impairment in older adults with mild cognitive impairment, increasing the rate of dementia conversion, while the continuous decline in cognitive function, in turn, accelerates the deterioration of depression. Art therapy is one of the effective non-pharmacological interventions widely used in dementia and psychological care. In order to enrich the interest of the study and increase the subjects' motivation to participate, it is considered that breaking away from the traditional art intervention model by embedding gamification elements and designing online video games may better help to improve cognitive function and physical and mental health of older adults. This project constructs an intervention program of online art games for older adults with mild cognitive impairment combined with subthreshold depression based on self-determination theory, and conducts a three-month randomized controlled trial to assess the improvement of online art games on participants' physical and mental health.
Read the detailed description
Subthreshold depression is a psychological sub-health state between normal psychological state and depression, and the existence of subthreshold depressive symptoms accelerates the quality of life decline and cognitive impairment in older adults with mild cognitive impairment, increasing the rate of dementia conversion, while the continuous decline of cognitive function will, in turn, accelerate the deterioration of depression. In recent years, there has been an increase in the attention paid to depression in people with mild cognitive impairment in China, but because subthreshold depression is currently difficult to recognize, research on subthreshold depression in people with mild cognitive impairment is still in the initial stage, and therefore more attention needs to be paid to this population to achieve early detection and intervention, otherwise, these older adults will be in a vicious cycle of worsening depression symptoms and accelerated cognitive decline, and their physical and mental health will be continuously Otherwise, these older adults will be in a vicious cycle of worsening depressive symptoms and accelerated cognitive decline, and their physical and mental health will be continuously damaged. Art therapy is one of the effective non-pharmacological interventions widely used in dementia and psychological care. Current art therapies are mostly in the form of offline interventions, and most participants may be poorly motivated to participate due to factors such as spatial distance, financial benefits, or lack of interest. More and more interventions, in order to enrich the interest of the study and improve the participant's motivation to participate, have begun to use online video game design with embedded gamification elements in their interventions to better help improve cognitive function and physical and mental health of older adults. Thus, incorporating online art games may become a new form of health intervention for older adults. This project constructs an online art game intervention program for older adults with mild cognitive impairment combined with subthreshold depression based on self-determination theory, and recruits older adult participants from nursing facilities to conduct a three-month randomized controlled trial using a scale to assess the health status of participants, with the aim of providing new evidence and ideas for the prevention and treatment of older adults with mild cognitive impairment combined with subthreshold depression in the high-risk population of older adults in China. The results of the study will provide theoretical and practical basis for personalized intervention for older adults with mild cognitive impairment combined with subthreshold depression.
- Conditions
- Mild Cognitive Impairment, Subthreshold Depression
- Being tested
- Online art game intervention group
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online art game intervention groupOther
The researchers conducted a prospective randomized controlled trial in which elderly patients with mild cognitive impairment combined with subthreshold depression who met the inclusion exclusion criteria were randomized into an online art game intervention group and a health education control group, with each group receiving an individualized intervention for 12 weeks. Participants in the experimental group created comic strips through an art game platform developed by the researchers' research team.
| Study group | Role | What they receive |
|---|---|---|
| Online art game intervention group | Experimental | Participants in this experimental group engaged in a three-month, twice-weekly, 1-hour group online art game intervention for a total of 24 sessions Receives: Other: Online art game intervention group |
| Health education control group | No intervention | Participants in the control group had health education and did not participate in the online art game. All others were the same as the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
The Montreal Cognitive Assessment Scale, developed by Nasreddine in 2004 to assess participants' general cognitive function, covers eight areas of cognitive assessment, including visuospatial and executive function, naming, memory, attention, speech, abstraction, delayed recall, and orientation. The Changsha version of the Montreal Cognitive Assessment Scale was used in this study, and its Cronbach's α coefficient was 0.846, retest reliability was 0.974, and investigator reliability was 0.969. The score of the Montreal Cognitive Assessment Scale ranges from 0 to 30 points. The higher the score, the better the cognitive function of the study subjects. The illiterate group ≤13, the primary school group ≤19, and the junior high school and above group ≤24 can be judged as impaired cognitive function to correct the bias caused by education level
Measured: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
Depression symptom
In this study, the 15-item Geriatric Depression Scale (GDS) was used to investigate the patients' psychological feelings in the last week, and each question was answered with "yes" or "no", and each question was assigned a value of 0 or 1 according to the different response status.The results were evaluated according to the following criteria: the total score range was 0-15, with 1-5 being subthreshold depression, 6-10 being depression, and 11-15 being severe depression [102]. The total score ranged from 0-15, with higher scores indicating more severe depression, of which 1-5 was subthreshold depression, 6-10 depression, and 11-15 severe depression.The internal consistency Cranach's alpha coefficient of the GDS-15 was 0.79, and the one-week retest reliability was 0.73. The internal consistency of the GDS-15 was 0.79, and the one-week retest reliability was 0.73.
Measured: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
Secondary outcomes (3)
Sleep quality
The Pittsburgh Sleep Quality Index, developed by Buysse equals in 1989, was used to evaluate the sleep status of the participants over the past month. The Pittsburgh Sleep Quality Index includes seven components: subjective sleep quality, sleep duration, sleep duration, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function, with good internal consistency (Cronbach's α=0.83) and retest reliability (r=0.85). The cumulative score for each component of the Pittsburgh Sleep Quality Index Scale is the total score of the scale, ranging from 0 to 21, with a score of 0 to 3 for each component, with higher scores associated with poorer sleep quality
Measured: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
Basic Psychological Needs
The Basic Psychological Needs Scale (BPNS) is an assessment tool developed by Gagne et al. to measure the degree of satisfaction of the three basic psychological needs of individuals: autonomy, competence, and affiliation. It consists of 21 items, including seven items for autonomy, six items for competence, and eight items for affiliation.
Measured: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
The quality of life
The World Health Organization Quality of Life Scale (WHOQOL-BREF) consists of 26 items, each with 5 corresponding answers, from which points are awarded to evaluate physiological, psychological, environmental, social relations, self-assessment and other aspects, and according to the conversion of the scale points to assess the patient's physiological, psychological and social relations and other aspects of the quality of life, with the higher the score indicating a better quality of life. The higher the score, the better the quality of life.
Measured: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start10 Sep 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 87 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
- NCT06706739
- Sponsor's protocol ID
- 2024-86
- Other IDs
- 2024-86
- Status last verified
- Mar 2025
- First submitted
- 25 Nov 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Combined Subthreshold Depression in Older Adults With Mild Cognitive Impairment Participating in Online Art Games
- ClinicalTrials.gov ID
- NCT06706739
- Acronym / sponsor ID
- 2024-86
- Conditions
- Mild Cognitive Impairment, Subthreshold Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Nov 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 presence of subthreshold depression accelerates quality of life decline and cognitive impairment in older adults with mild cognitive impairment, increasing the rate of dementia conversion, while the continuous decline in cognitive function, in turn, accelerates the deterioration of depression. Art therapy is one of the effective non-pharmacological interventions widely used in dementia and psychological care. In order to enrich the interest of the study and increase the subjects' motivation to participate, it is considered that breaking away from the traditional art intervention model by embedding gamification elements and designing online video games may better help to improve cognitive function and physical and mental health of older adults. This project constructs an intervention program of online art games for older adults with mild cognitive impairment combined with subthreshold depression based on self-determination theory, and conducts a three-month randomized controlled trial to assess the improvement of online art games on participants' physical and mental health.
Detailed description
Subthreshold depression is a psychological sub-health state between normal psychological state and depression, and the existence of subthreshold depressive symptoms accelerates the quality of life decline and cognitive impairment in older adults with mild cognitive impairment, increasing the rate of dementia conversion, while the continuous decline of cognitive function will, in turn, accelerate the deterioration of depression. In recent years, there has been an increase in the attention paid to depression in people with mild cognitive impairment in China, but because subthreshold depression is currently difficult to recognize, research on subthreshold depression in people with mild cognitive impairment is still in the initial stage, and therefore more attention needs to be paid to this population to achieve early detection and intervention, otherwise, these older adults will be in a vicious cycle of worsening depression symptoms and accelerated cognitive decline, and their physical and mental health will be continuously Otherwise, these older adults will be in a vicious cycle of worsening depressive symptoms and accelerated cognitive decline, and their physical and mental health will be continuously damaged. Art therapy is one of the effective non-pharmacological interventions widely used in dementia and psychological care. Current art therapies are mostly in the form of offline interventions, and most participants may be poorly motivated to participate due to factors such as spatial distance, financial benefits, or lack of interest. More and more interventions, in order to enrich the interest of the study and improve the participant's motivation to participate, have begun to use online video game design with embedded gamification elements in their interventions to better help improve cognitive function and physical and mental health of older adults. Thus, incorporating online art games may become a new form of health intervention for older adults. This project constructs an online art game intervention program for older adults with mild cognitive impairment combined with subthreshold depression based on self-determination theory, and recruits older adult participants from nursing facilities to conduct a three-month randomized controlled trial using a scale to assess the health status of participants, with the aim of providing new evidence and ideas for the prevention and treatment of older adults with mild cognitive impairment combined with subthreshold depression in the high-risk population of older adults in China. The results of the study will provide theoretical and practical basis for personalized intervention for older adults with mild cognitive impairment combined with subthreshold depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online art game intervention group | Experimental | Other: Online art game intervention groupParticipants in this experimental group engaged in a three-month, twice-weekly, 1-hour group online art game intervention for a total of 24 sessions |
| Health education control group | No intervention | –Participants in the control group had health education and did not participate in the online art game. All others were the same as the experimental group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: ≥60 years old;
- Meet the diagnostic criteria of mild cognitive impairment and subthreshold depression;
- Possess basic comprehension and verbal expression ability; Voluntarily participate in this study and sign the informed consent form.
Key exclusion criteria (5 listed)
- Patients who have been diagnosed with depression, including patients with organic mental disorders and patients with previous history of depression-related mental disorders;
- Patients with cognitive disorders caused by other diseases (e.g. neurological and psychiatric diseases, metabolic disorders, poisoning, infections, etc.);
- Patients with severe cardiac, hepatic, and renal diseases;
- Patients with severe chronic diseases and comorbidities, such as patients with congestive heart failure and patients with hypertension and diabetes mellitus, etc., who suffer from severe complications.
- Patients with serious chronic diseases and comorbidities, such as congestive heart failure, hypertension, diabetes and other diseases combined 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online art game intervention groupThe researchers conducted a prospective randomized controlled trial in which elderly patients with mild cognitive impairment combined with subthreshold depression who met the inclusion exclusion criteria were randomized into an online art game intervention group and a health education control group, with each group receiving an individualized intervention for 12 weeks. Participants in the experimental group created comic strips through an art game platform developed by the researchers' research team. | Other | Online art game intervention group |
Primary outcome
Cognitive function
Time frame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
The Montreal Cognitive Assessment Scale, developed by Nasreddine in 2004 to assess participants' general cognitive function, covers eight areas of cognitive assessment, including visuospatial and executive function, naming, memory, attention, speech, abstraction, delayed recall, and orientation. The Changsha version of the Montreal Cognitive Assessment Scale was used in this study, and its Cronbach's α coefficient was 0.846, retest reliability was 0.974, and investigator reliability was 0.969. The score of the Montreal Cognitive Assessment Scale ranges from 0 to 30 points. The higher the score, the better the cognitive function of the study subjects. The illiterate group ≤13, the primary school group ≤19, and the junior high school and above group ≤24 can be judged as impaired cognitive function to correct the bias caused by education level
Depression symptom
Time frame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
In this study, the 15-item Geriatric Depression Scale (GDS) was used to investigate the patients' psychological feelings in the last week, and each question was answered with "yes" or "no", and each question was assigned a value of 0 or 1 according to the different response status.The results were evaluated according to the following criteria: the total score range was 0-15, with 1-5 being subthreshold depression, 6-10 being depression, and 11-15 being severe depression [102]. The total score ranged from 0-15, with higher scores indicating more severe depression, of which 1-5 was subthreshold depression, 6-10 depression, and 11-15 severe depression.The internal consistency Cranach's alpha coefficient of the GDS-15 was 0.79, and the one-week retest reliability was 0.73. The internal consistency of the GDS-15 was 0.79, and the one-week retest reliability was 0.73.
3 secondary outcomes
Sleep quality
Time frame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
Basic Psychological Needs
Time frame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
The quality of life
Time frame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
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 11 Mar 2025.
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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?
A study testing Online art game intervention group in people with 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 3 inclusion and 5 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 11 Mar 2025. 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?
Cognitive function (time frame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.). The study lists 2 primary outcomes in all. 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 11 Mar 2025.