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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAnhui Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Community-Family Mutual Support Intervention

    Other 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.

  • Routine Community Care

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Community-Family Mutual Support InterventionExperimental treatment 1 intervention
Group B: Routine Community CareActive comparator 1 intervention

Trial outcomes

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

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.

Time frame
From enrollment to the end of treatment at 8 weeks
2

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

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Anhui Medical University

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Collaborator

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