Mild Cognitive Impairment (MCI)iactNCT07332624
Instant Message-delivered Personalised Acceptance and Commitment Therapy (ACT) for Neuropsychiatric Symptoms in Persons With Mild Cognitive Impairment
A study testing Automated instant message-guided neuropsychiatric symptoms management in people with Mild Cognitive Impairment (MCI), run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Automated instant message-guided neuropsychiatric symptoms management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Sep 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of dementia; Diagnosis of psychiatric disease; Currently participating in any type of psychological or behavioural intervention for NPSs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Automated instant message-guided neuropsychiatric symptoms management
- Keywords
- mild cognitive impairment, acceptance and commitment therapy, neuropsychiatric symptoms
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated instant message-guided neuropsychiatric symptoms managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
Depressive symptoms (PHQ-9)
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.
Measured: 8 weeks
Anxiety symptoms (GAD-7)
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom
Measured: 8 weeks
Cognitive functions (HK-MoCA)
The total score is calculated by summing up the score of all items. Higher scores indicate better cognitive function.
Measured: 8 weeks
Acceptance of negative emotions and valued-based actions (AAQ-II)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start17 Sep 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung Jae LEE, Principal investigator, School of nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332624
- Sponsor's protocol ID
- iact2025
- Acronym
- iact
- Status last verified
- Sep 2025
- First submitted
- 29 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instant Message-delivered Acceptance and Commitment Therapy (ACT) for Neuropsychiatric Symptoms in Persons Living With Mild Cognitive Impairment: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07332624
- Acronym / sponsor ID
- iact / iact2025
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- mild cognitive impairment, acceptance and commitment therapy, neuropsychiatric symptoms
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Automated instant message-guided neuropsychiatric symptoms managementParticipants 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). |
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Diagnosis of dementia; Diagnosis of psychiatric disease; Currently participating in any type of psychological or behavioural intervention for NPSs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated instant message-guided neuropsychiatric symptoms managementParticipants 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. | Behavioural | Intervention group |
Primary outcome
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.
4 secondary outcomes
Depressive symptoms (PHQ-9)
Time frame: 8 weeks
Anxiety symptoms (GAD-7)
Time frame: 8 weeks
Cognitive functions (HK-MoCA)
Time frame: 8 weeks
Acceptance of negative emotions and valued-based actions (AAQ-II)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jung Jae LEE principal investigator
School of nursing, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated instant message-guided neuropsychiatric symptoms management in people with Mild Cognitive Impairment (MCI), run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MBI-C scores (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.