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

NCT06706739 | Completed

• 1 other identifier: 2024-86
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Subthreshold Depression

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.

Secondary Outcomes (3)

• Sleep quality

  The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.

• Basic Psychological Needs

  The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.

• The quality of life

  The intervention took place in October 2024 and was assessed at 0,1.5, and 3 months respectively.

Study Arms (2)

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

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.

Interventions

Online art game intervention group OTHER

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.

Online art game intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian provincial hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• DanTing Chen

  Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: September 10, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

CN (1)