Applied Research on a Non-pharmacological Intervention Program for Older Adults With Subjective Cognitive Decline

NCT07629531 | Not Yet Recruiting

• 1 other identifier: 【2026】161
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to verify the short-term and long-term effects of a group-based non-pharmacological intervention program for community-dwelling older adults with subjective cognitive decline, and to evaluate its implementation outcomes, through a rigorously designed cluster randomized controlled trial.

Conditions

Non-Pharmacological Interventions

Outcome Measures

Primary Outcomes (5)

• Episodic memory

  Using the Huashan version of the Auditory Verbal Learning Test (AVLT) for assessment, it is mainly used to evaluate immediate recall, short-delay recall, long-delay recall, and other key components. The test includes 12 words belonging to three semantic categories (4 words per category). The testing procedure is as follows: The examiner reads out the 12 words in sequence, and the subject immediately recalls them. This process is repeated three consecutive times to form the immediate memory test. After an interval of 5 minutes, short-delay recall is conducted, and after 20 minutes, long-delay recall is implemented. The scoring rule is that each correctly recalled word earns 1 point. The immediate memory score is the sum of correct recalls from the first three trials (maximum score 36). This study records the scores for immediate recall, short-delay recall, and long-delay recall, with higher scores indicating better memory function.

  week0，week12，week24

• Gobal cognitive function

  The assessment uses the Montreal Cognitive Assessment (MoCA). Higher scores indicate better performance, with a minimum score of 0 and a maximum score of 30.

  week0，week12，week24

• Executive function

  The Shape Trail Test (STT) was used to assess executive function. The test consists of two parts: Part A requires participants to connect 25 numbers in ascending order; Part B involves 25 numbers presented within two different shapes. The scoring indicators are the time taken to complete STT-A and STT-B, with shorter completion times indicating better executive function.

  week0，week12，week24

• Attention

  The Digit Symbol Substitution Test (DSST) is used to assess the patient's attention. The subject is required to match the corresponding symbols to the numbers (1-9) as quickly as possible within 90 seconds. Each correctly filled symbol earns 1 point, and a reversed symbol earns 0.5 points. The maximum score for the test is 90.

  week0，week12，week24

• Linguistic function

  Animal verbal fluency is used to assess a patient's language fluency. The test requires the subject to name as many examples as possible within the category of animals in one minute. Scoring is typically based on the total number of correctly named animal names. Lower scores indicate reduced language ability.

  week0，weel12，week24

Secondary Outcomes (5)

• Depression

  week0，weel12，week24

• Anxiety

  week0，week12，week24

• Social network

  week0，week12，week24

• Social participation

  week0，week12，week24

• Timed "Up and Go" test

  week0，week12，week24

Study Arms (2)

Non-Pharmacological Interventions

EXPERIMENTAL

Non-Pharmacological Interventions

Other: non-pharmacological interventions

Waiting List Control Group

OTHER

To ensure ethical fairness, the same intervention program will subsequently be provided to the waitlist control group after positive effects are confirmed in the intervention group.

Other: Waiting List

Interventions

non-pharmacological interventions OTHER

6 components(social intercourse, cognitive interventions, physical activities interventions, rational diet, understanding and risk management of diseases, emotion management)

Non-Pharmacological Interventions

Waiting List OTHER

To ensure ethical fairness, the same intervention program will subsequently be provided to the waitlist control group after positive effects are confirmed in the intervention group.

Waiting List Control Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• China Medical University, China: lead

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

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: Dr

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share