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NCT Number: NCT07703267

Non-pharmacological Interventions for People With Mild Cognitive Impairment in the Community

Mild cognitive impairment (MCI) may increase the risk of dementia. This study will evaluate an 8-week community-family mutual support intervention for adults aged 60 years or older with MCI. Participants will be randomly assigned to an intervention group or a control group. The control group will receive routine community care, while the intervention group will additionally receive cognitive training, health education, family support, mutual support activities, and individualized feedback. Cognitive function, daily functioning, emotional status, and social support will be assessed before and after the intervention.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 60 years or older.
  • Meets the diagnostic criteria for mild cognitive impairment, including subjective cognitive decline, objective impairment in at least one cognitive domain, relatively preserved activities of daily living, and no diagnosis of dementia.
  • Has lived in the study community for at least 6 months.
  • Has completed primary school or above and is able to read and write.
  • Is able to communicate and complete the study assessments and intervention activities.
  • Voluntarily participates and provides written informed consent.

Exclusion criteria

  • Unable to communicate effectively.
  • Has severe visual or hearing impairment that prevents participation.
  • Has dementia, schizophrenia, or another severe psychiatric disorder.
  • Has a serious or unstable physical illness that prevents participation in the intervention.
  • Is currently participating in another cognitive training or similar intervention study.

Treatment and study plan

Community-Family Mutual Support Intervention

Other

Participants will receive an 8-week community-family mutual support intervention in addition to routine community care. Guided by social support theory, the program integrates informational, emotional, instrumental, and appraisal support. It includes MCI-related health education, cognitive training, physical activity guidance, emotional self-monitoring, home-based practice with family assistance, mutual support between paired families, group activities, and individualized feedback. The intervention will be delivered through community-based sessions and supported home activities by trained researchers and community nurses.

Routine Community Care

Other

Participants will receive routine community care, including standard health education and usual community-based health services, during the 8-week study period. They will not receive the community-family mutual support intervention.

Primary outcomes

  1. Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: From enrollment to the end of treatment at 8 weeks

Secondary outcomes

  1. Change From Baseline in Social Support Rating Scale (SSRS) Total Score

    Time frame: From enrollment to the end of treatment at 8 weeks

    Social support will be assessed using the 10-item Social Support Rating Scale (SSRS). The total score ranges from 12 to 66 points, with higher scores indicating greater social support. The outcome measure is the change in the total score from baseline to Week 8.

  2. Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score

    Time frame: From enrollment to the end of treatment at 8 weeks

    Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. The outcome measure is the change in the PHQ-9 total score from baseline to Week 8.

Study contacts

Contact information is provided by the study sponsor or research team.

Yiran Yue

CONTACT

[email protected]

8617333266696

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Collaborators

  • The First Affiliated Hospital of Anhui Medical University

Registry information

Official study title

Development of a 'Community-Family Mutual Support' Intervention Model for Patients With Mild Cognitive Impairment Based on Social Support Theory

Acronym: CNPI-MCI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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