Clinical trial NCT06706739: A Trial of Combined Subthreshold Depression in Older Adults With Mild Cognitive Impairment Participating in Art Games
Official title: A Randomized Controlled Trial of Combined Subthreshold Depression in Older Adults With Mild Cognitive Impairment Participating in Online Art Games
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Subthreshold Depression
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 87
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive function
timeFrame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
measure: Depression symptom
timeFrame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
Secondary outcomes:
measure: Sleep quality
timeFrame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
measure: Basic Psychological Needs
timeFrame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
measure: The quality of life
timeFrame: The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.
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: