Subjective Cognitive Decline (SCD)NCT06622889
The Effectiveness of Interventions Targeting Self-Perception of Aging in Older Adults with Subjective Cognitive Decline
A study testing Multidomain Intervention Program in people with Subjective Cognitive Decline (SCD), run by Zheng Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Subjective Cognitive Decline (SCD)
- What is being tested?
- Multidomain Intervention Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100144
About this study
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.
Read the 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.
- Conditions
- Subjective Cognitive Decline (SCD)
- Being tested
- Multidomain Intervention Program
- Keywords
- Subjective Cognitive Decline, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain Intervention ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 8-week intervention targeting self-perception of aging | Experimental | 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. Receives: Other: Multidomain Intervention Program |
| Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Cognitive Decline
The 9-item Subjective Cognitive Decline Questionnaire (SCD-Q9) consists of 9 items. Higher scores indicate a greater likelihood of subjective cognitive impairment.
Measured: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
Secondary outcomes (4)
Cognitive Function
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.
Measured: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
Self-perception of Aging
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.
Measured: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
Perceived Stress
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.
Measured: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
Coping Strategies
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.
Measured: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive Decline (SCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Li, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622889
- Sponsor's protocol ID
- PUMCSON-2023-05
- Status last verified
- Nov 2024
- First submitted
- 27 Sep 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Interventions Targeting Self-Perception of Aging in Older Adults with Subjective Cognitive Decline
- ClinicalTrials.gov ID
- NCT06622889
- Acronym / sponsor ID
- PUMCSON-2023-05
- Conditions
- Subjective Cognitive Decline (SCD)
- Keywords
- Subjective Cognitive Decline, Older Adults
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Zheng LiUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8-week intervention targeting self-perception of aging | Experimental | Other: Multidomain Intervention ProgramParticipants 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. |
| Controls | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidomain Intervention ProgramThe 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. | Other | 8-week intervention targeting self-perception of aging |
Primary outcome
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.
4 secondary outcomes
Cognitive Function
Time frame: 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)
Perceived Stress
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain Intervention Program in people with Subjective Cognitive Decline (SCD), run by Zheng Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Cognitive Decline (time frame: Baseline (pre-intervention)，8 weeks (post-intervention)，and 16 weeks (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.