- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07332624
Instant Message-delivered Personalised Acceptance and Commitment Therapy (ACT) for Neuropsychiatric Symptoms in Persons With Mild Cognitive Impairment (iact)
December 29, 2025 updated by: The University of Hong Kong
Instant Message-delivered Acceptance and Commitment Therapy (ACT) for Neuropsychiatric Symptoms in Persons Living With Mild Cognitive Impairment: a Pilot Randomised Controlled Trial
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
- Message contents: The message content library will consist of two parts: 1. brief mild cognitive impairment messages (optional), and 2. acceptance and commitment therapy messages (mandatory).
Message delivery
- Regular messages: The messages in the two parts will be sent regularly to each participant. As personalisation is a core process subject to behavioural changes, the content, frequency, and timing of the messages will be determined based on participants' preferences. To save labour and increase efficiency, we will develop a message 'scheduler' program. We will pre-set the message scheduler, which will then automatically send out content to participants according to their preferences. The development of the program is highly useful particularly in cases which participants prefer to receive messages during non-office hours.
- Therapist-led real-time support messages (chat-type): Chat-based support will be given to the participants as an extension of the regular messages. However, the participants will be informed beforehand that the RA will only play a supportive role and will not provide formal care. The number of the chat messages will not be limited, but the real-time support messages will only be provided during working hours (i.e., 9am-6pm) on weekdays to limit the RA's workload.
Control Group:
The control group will receive instant messages about mental health management from HKSAR Government website (https://www.shallwetalk.hk/en/mental-well-being/mental-well-being-is-related-to-you/), which is open to the public.
Study Type
Interventional
Enrollment (Estimated)
40
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 Locations
-
-
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Hong Kong, Hong Kong
- The University of Hong Kong
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-
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:
- 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.
Exclusion Criteria:
- Diagnosis of dementia; Diagnosis of psychiatric disease; Currently participating in any type of psychological or behavioural intervention for NPSs
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
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).
|
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.
|
|
No Intervention: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MBI-C scores
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms (PHQ-9)
Time Frame: 8 weeks
|
Each item was scored on a 4-point scale (0 "not at all" to 3 "nearly every day").
The total score is calculated by summing up the score of all items (range 0-27).
High scores indicate worse depressive symptoms.
|
8 weeks
|
|
Anxiety symptoms (GAD-7)
Time Frame: 8 weeks
|
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom
|
8 weeks
|
|
Cognitive functions (HK-MoCA)
Time Frame: 8 weeks
|
The total score is calculated by summing up the score of all items.
Higher scores indicate better cognitive function.
|
8 weeks
|
|
Acceptance of negative emotions and valued-based actions (AAQ-II)
Time Frame: 8 weeks
|
AAQ-II is a measure of psychological flexibility.
Each item is rated on a 7-point scale from 1 = never true to 7 = always true.
Scores range from 1-49.
A lower score indicates a lower level of psychological flexibility.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jung Jae LEE, School of nursing, The University of Hong Kong
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 (Actual)
September 17, 2025
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
December 29, 2025
First Submitted That Met QC Criteria
December 29, 2025
First Posted (Estimated)
January 12, 2026
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
December 29, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- iact2025
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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