NCT07420426

Brief Summary

This study aims to develop an automated instant message-delivered intervention (i.e., EMI) for people with mild cognitive impairment to reduce their NPS, and to investigate the feasibility and effectiveness of the intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress43%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 8, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 12, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

mild cognitive impairmentacceptance and commitment therapyneuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

  • MBI-C scores

    The primary outcome will be MBI-C scores to assess NPSs. A higher MBI-C scores will indicate a higher level of neuropsychiatric symptoms.

    at baseline, 10th week and 24th week

Secondary Outcomes (6)

  • Depressive symptoms (PHQ-9)

    at baseline, 10th week and 24th week

  • Anxiety symptoms (GAD-7)

    at baseline, 10th week and 24th week

  • Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])

    at baseline, 10th week and 24th week

  • Cognitive functions (HK-MoCA)

    at baseline, 10th week and 24th week

  • Acceptance of negative emotions and valued-based actions (AAQ-II)

    at baseline, 10th week and 24th week

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in intervention group will receive the EMI for 9 weeks. Based on the steps of mobile message development recommended by Abroms, et al., our multidisciplinary team - including a neurologist, nurses, clinical psychologists and gerontologists - will develop an ACT message content library and protocol for IM delivery (i.e. EMI).

Behavioral: automated instant message-guided neuropsychiatric symptoms management

Control group

ACTIVE COMPARATOR

The control group will receive instant messages about general mental health management from the HKSAR Government website in 9 weeks, which is open to the public (https://www.shallwetalk.hk/en/mental-well-being/mental-well-being-is-related-to-you/), with reminder text messages of follow-up surveys.

Behavioral: general mental health management

Interventions

Participants in intervention group will receive the EMI for 9 weeks. Based on the steps of mobile message development recommended by Abroms, et al., we will develop a message content library and protocol for EMI delivery.

Intervention group

Participants in control group will receive the messages for 9 weeks. The control group will receive instant messages about general mental health management from the HKSAR Government website, which is open to the public (https://www.shallwetalk.hk/en/mental-well-being/mental-well-being-is-related-to-you/), with reminder text messages of follow-up surveys.

Control group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling adults aged ≥ 50 years
  • HK-MoCA score ranged from 18 to 22
  • MBI-C ≥7
  • SCD-9 ≥3
  • IADL =18
  • Able to read and communicate in Chinese
  • Able to use the text or voice messaging function on a smartphone

You may not qualify if:

  • Clinical diagnosis of dementia
  • Clinical diagnosis of psychiatric disease
  • Currently participating in any type of psychological or behavioural intervention for NPSs
  • Currently taking psychiatric medication
  • Currently receiving acute care or post-acute hospitalization care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (36)

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MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Doris Sau Fung Yu, Professor

    School of nursing, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris Sau Fung Yu, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations