NCT06622889

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

September 27, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

Subjective Cognitive DeclineOlder Adults

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (pre-intervention),8 weeks (post-intervention),and 16 weeks (follow-up)

Secondary Outcomes (4)

  • Cognitive Function

    Baseline (pre-intervention),8 weeks (post-intervention),and 16 weeks (follow-up)

  • Self-perception of Aging

    Baseline (pre-intervention),8 weeks (post-intervention),and 16 weeks (follow-up)

  • Perceived Stress

    Baseline (pre-intervention),8 weeks (post-intervention),and 16 weeks (follow-up)

  • Coping Strategies

    Baseline (pre-intervention),8 weeks (post-intervention),and 16 weeks (follow-up)

Other Outcomes (3)

  • Satisfaction questionnaire

    8 weeks (post-intervention)

  • Compliance

    8 weeks (post-intervention)

  • Acceptability interview

    8 weeks (post-intervention)

Study Arms (2)

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.

Other: Multidomain Intervention Program

Controls

NO INTERVENTION

Interventions

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.

8-week intervention targeting self-perception of aging

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100144, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 2, 2024

Study Start

November 1, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations