The Effectiveness of Interventions Targeting Self-Perception of Aging in Older Adults with Subjective Cognitive Decline

November 26, 2024 updated by: Zheng Li
Subjective cognitive decline (SCD) represents the initial clinical manifestation in the disease spectrum of Alzheimer's Disease (AD). It represents an essential stage for early prevention and treatment of cognitive impairment, making the SCD population an optimal target for prior intervention. This study aims to assess the feasibility and efficacy of an 8-week intervention targeting self-perception of aging in community-dwelling older adults with SCD.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Dementia, especially Alzheimer's Disease (AD), is a major healthcare issue in aging populations. It not only threatens the physical and mental health of older adults but also imposes significant economic and caregiving burdens on families and society. As a preclinical stage of AD, subjective cognitive decline (SCD) is regarded as the optimal phase for early intervention in cognitive impairment. When confronted with the threats of physical, psychological, and social aging, older adults with SCD often hold negative perceptions and emotional responses toward their own aging. They tend to attribute physical decline and memory loss to normal aging processes, overlooking controllable factors, which poses potential risks to their future cognitive outcomes, such as accelerated cognitive decline, elevated dementia risk, and increased accumulation of AD biomarkers. This study is based on the Transactional Model of Stress and Coping (TMSC) and identifies the mechanisms through which self-perception of aging influences cognitive function in older adults with SCD. A comprehensive 8-week intervention program was developed to target these mechanisms. The 8-week intervention program aims to provide practical evidence for delaying cognitive decline in older adults with SCD by enhancing their positive perceptions of aging.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • 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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100144
        • School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged ≥60 years;
  • residing in the community for 6 months at least;
  • experiencing a consistent decline in self-reported cognitive abilities;
  • having standard cognitive test performance in the normal range;
  • willing to participate in this study.

Exclusion Criteria:

  • having diagnosis of any neurological diseases including Parkinson's disease, brain tumor, cerebral infarction, encephalitis, epilepsy, etc.;
  • having diagnosis of mental illness such as depression, anxiety, bipolar disorder, and schizophrenia;
  • with history of substance abuse or addiction;
  • with severe visual or hearing impairment.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controls
Experimental: 8-week intervention targeting self-perception of aging
Participants in this condition will receive an 8-week intervention targeting self-perception of aging. Group sessions will be held at community health service centers, with one session per week, each lasting 45 to 60 minutes. Additionally, homework assignments will be supplemented, and researchers will provide additional remote support via WeChat.
Other: Multidomain Intervention Program
The intervention program aims to help older adults with subjective cognitive decline understand the aging process and adopt a positive attitude toward aging, highlighting age-related benefits. The sessions also provide emotion regulation techniques and stress-coping strategies to encourage proactive problem-solving and build confidence in handling challenges. By recalling positive life experiences, the program seeks to strengthen emotional connections, enhance the sense of belonging, and reconstruct a meaningful later life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Cognitive Decline
Time Frame: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
The 9-item Subjective Cognitive Decline Questionnaire (SCD-Q9) consists of 9 items. Higher scores indicate a greater likelihood of subjective cognitive impairment.
Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function
Time Frame: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
The Montreal Cognitive Assessment Beijing Version (MoCA-Beijing) encompasses multiple cognitive domains, including visuospatial execution ability, naming, memory and delayed recall, attention, language, abstraction, and orientation. The total score ranges from 0 to 30 points, and the higher the score, the better the overall cognitive function. Assessment tools of other cognitive domains will be used depending on the progress of the intervention program.
Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
Self-perception of Aging
Time Frame: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
The Chinese version of the Brief Aging Perceptions Questionnaire (B-APQ) comprises 17 items grouped into 5 dimensions. Participants rated their agreement on a Likert 5-point scale ranging from "strongly disagree" to "strongly agree" (1 to 5 scores). The total score ranges from 17 to 85 points, with higher scores indicating more negative self-perceived aging.
Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
Perceived Stress
Time Frame: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
The Chinese version of the Perceived Stress Scale (CPSS) will be used to measure individuals' perceived stress when facing stressful events. It consists of 14 items, with higher scores indicating higher level of perceived stress.
Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
Coping Strategies
Time Frame: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
The Simplified Coping Skill Questionnaire (SCSQ) includes two dimensions: positive coping and negative coping. Higher average scores in each dimension indicate a greater frequency of using that particular coping strategy.
Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction questionnaire
Time Frame: 8 weeks (post-intervention)
The satisfaction questionnaire designed by the researchers will be used.
8 weeks (post-intervention)
Compliance
Time Frame: 8 weeks (post-intervention)
Percentage of participants who complete the whole intervention program, and the reasons for failure to comply
8 weeks (post-intervention)
Acceptability interview
Time Frame: 8 weeks (post-intervention)
After the end of the whole intervention, semi-structured interviews will be conducted with the subjects of the intervention group who volunteered to participate in the interview.
8 weeks (post-intervention)

Collaborators and Investigators

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

Sponsor

Zheng Li

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)

November 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCSON-2023-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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