A Trial of Combined Subthreshold Depression in Older Adults With Mild Cognitive Impairment Participating in Art Games

March 10, 2025 updated by: Dan Ting Chen, Fujian Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online art game intervention group
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
Other: Online art game intervention group
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.
No Intervention: Health education control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
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.
The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
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
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 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.
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.
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.
The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: DanTing Chen, Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-86 (Other Identifier: Biomedical Ethics Review Committee of Fujian Medical University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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