Non-pharmacological Interventions for People With Mild Cognitive Impairment in the Community (CNPI-MCI)

July 11, 2026 updated by: Yiran Yue, Anhui Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

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 Contact

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 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.

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community-Family Mutual Support Intervention
Participants will receive routine community care plus an 8-week community-family mutual support intervention based on social support theory. The intervention includes health education, cognitive training, emotional self-monitoring, family involvement, mutual support between participating families, group activities, and individualized feedback.
Other: Community-Family Mutual Support Intervention
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.
Active Comparator: Routine Community Care
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.
Other: Routine Community Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

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

Sponsor

Anhui Medical University

Collaborators

The First Affiliated Hospital of Anhui Medical University

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 (Estimated)

July 28, 2026

Primary Completion (Estimated)

September 28, 2026

Study Completion (Estimated)

October 28, 2026

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81251000 (Other Grant/Funding Number: Biomedical Ethics Committee of Anhui Medical University)

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

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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