NCT07332624

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 12, 2026

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

December 29, 2025

Last Update Submit

December 29, 2025

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.

    8 weeks

Secondary Outcomes (4)

  • Depressive symptoms (PHQ-9)

    8 weeks

  • Anxiety symptoms (GAD-7)

    8 weeks

  • Cognitive functions (HK-MoCA)

    8 weeks

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

    8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in intervention group will receive the EMI for 8 weeks. Based on the steps of mobile message development recommended by Abroms, et al., our team 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

NO INTERVENTION

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.

Interventions

Participants in intervention group will receive the EMI for 8 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

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 range from 18 to 25; MBI-C ≥7; Able to read and communicate in Chinese (Cantonese or Putonghua); Able to use the text or voice messaging function on a smartphone.

You may not qualify if:

  • Diagnosis of dementia; Diagnosis of psychiatric disease; Currently participating in any type of psychological or behavioural intervention for NPSs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jung Jae LEE

    School of nursing, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 12, 2026

Study Start

September 17, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 12, 2026

Record last verified: 2025-09

Locations