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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

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

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 (Estimated)

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.
64

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
    • 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

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:

  • 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

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.
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

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
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

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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

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.
November 1, 2024

Primary Completion (Estimated)

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.
June 30, 2025

Study Completion (Estimated)

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.
June 30, 2025

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).
September 27, 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.
October 1, 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.
October 2, 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.
November 29, 2024

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.
November 26, 2024

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.
November 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 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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