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Mild Cognitive Impairment (MCI)IMPACTNCT07420426

Instant Message-delivered Personalised Acceptance and Commitment Therapy (IMPACT) for Neuropsychiatric Symptoms in Persons With Mild Cognitive Impairment

A study testing automated instant message-guided neuropsychiatric symptoms management and general mental health management in people with Mild Cognitive Impairment (MCI), run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. 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 and general mental health management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteHong Kong
Study dates
8 Dec 2025to 31 Dec 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 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Doris Sau Fung Yu, Professor contact

+852 3917 6319

dyu1@hku.hk

Hong Kong1 site, 1 recruiting
  • The University of Hong Kong

    Hong Kong

    Doris Sau Fung Yu, PhD, +852 3917 6319, dyu1@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Instant Message-delivered Personalised Acceptance and Commitment Therapy (IMPACT) for Neuropsychiatric Symptoms in Persons With Mild Cognitive Impairment: a Mixed Methods Study

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.

Read the detailed description
  1. Message contents: The message content library will consist of four parts: 1.orientation, 2. brief mild cognitive impairment education messages, 3. acceptance and commitment therapy messages, 4.booster message.
  2. Message delivery
  • Regular messages: The messages in the four parts will be sent regularly to each participant. As personalisation is a core process subject to behavioural changes, the timing of the messages will be determined based on participants' preferences. To save labour and increase efficiency, the investigators will develop a message 'scheduler' program. The investigators will pre-set the message scheduler, which will then automatically send out content to the 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.
  • 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 on weekdays to limit the RA's workload.

Control Group:

The control group will receive instant messages about mental health management from GovHK website (https://www.gov.hk/en/residents/health/mental/), which is open to the public.

Being tested
automated instant message-guided neuropsychiatric symptoms management, general mental health 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 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.

  • general mental health managementBehavioural

    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.

Study groups in NCT07420426
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants 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).
Receives: Behavioral: automated instant message-guided neuropsychiatric symptoms management
Control groupActive comparatorThe 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.
Receives: Behavioral: general mental health management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at baseline, 10th week and 24th week

Secondary outcomes (6)
  1. 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: at baseline, 10th week and 24th week

  2. Anxiety symptoms (GAD-7)

    A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom

    Measured: at baseline, 10th week and 24th week

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

    The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity, with scores ranging from -0.864 to 1, where higher scores indicate better quality of life. Additionally, it includes a visual analogue scale (VAS), ranging from 0 (the worst health imaginable) to 100 (the best health imaginable).

    Measured: at baseline, 10th week and 24th week

  4. Cognitive functions (HK-MoCA)

    The total score is calculated by summing up the score of all items. Higher scores indicate better cognitive function.

    Measured: at baseline, 10th week and 24th week

  5. 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: at baseline, 10th week and 24th week

  6. Subjective Cognitive Decline scale (SCD-9)

    SCD-9 is a scale detecting subjective cognitive function. Higher socre indicate worse subjective cognitive function.

    Measured: at baseline, 10th week and 24th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start8 Dec 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07420426
Sponsor's protocol ID
IMPACT2025
Acronym
IMPACT
Status last verified
Feb 2026
First submitted
12 Feb 2026
Last updated
18 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Younas A, Pedersen M, Durante A. Characteristics of joint displays illustrating data integration in mixed-methods nursing studies. J Adv Nurs. 2020 Feb;76(2):676-686. doi: 10.1111/jan.14264. Epub 2019 Nov 25.

    PubMed 31713252
  • Abroms LC, Whittaker R, Free C, Mendel Van Alstyne J, Schindler-Ruwisch JM. Developing and Pretesting a Text Messaging Program for Health Behavior Change: Recommended Steps. JMIR Mhealth Uhealth. 2015 Dec 21;3(4):e107. doi: 10.2196/mhealth.4917.

    PubMed 26690917
  • Ong CW, Lee EB, Twohig MP. A meta-analysis of dropout rates in acceptance and commitment therapy. Behav Res Ther. 2018 May;104:14-33. doi: 10.1016/j.brat.2018.02.004. Epub 2018 Feb 16.

    PubMed 29477890
  • Serdar CC, Cihan M, Yucel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021 Feb 15;31(1):010502. doi: 10.11613/BM.2021.010502. Epub 2020 Dec 15.

    PubMed 33380887
  • Xu L, Li T, Xiong L, Wang X, Ismail Z, Fukuda M, Sun Z, Wang J, Gauthier S, Yu X, Wang H. Reliability and Validity of the Chinese Version of Mild Behavioral Impairment Checklist in Mild Cognitive Impairment and Mild Alzheimer's Disease. J Alzheimers Dis. 2021;81(3):1141-1149. doi: 10.3233/JAD-210098.

    PubMed 33935092
  • Lin RS, Yu DS, Chau PH, Li PW, Ismail Z. Reliability and Validity of the Traditional Chinese Version of the Mild Behavioral Impairment - Checklist Among Persons With Mild Cognitive Impairment - A Validation Study. J Geriatr Psychiatry Neurol. 2023 Jan;36(1):26-38. doi: 10.1177/08919887221093363. Epub 2022 Apr 18.

    PubMed 35430911
  • Yu DS, Li PW, Zhang F, Cheng ST, Ng TK, Judge KS. The effects of a dyadic strength-based empowerment program on the health outcomes of people with mild cognitive impairment and their family caregivers: a randomized controlled trial. Clin Interv Aging. 2019 Oct 4;14:1705-1717. doi: 10.2147/CIA.S213006. eCollection 2019.

    PubMed 31686796
  • Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.

    PubMed 25125421
  • Bai W, Chen P, Cai H, Zhang Q, Su Z, Cheung T, Jackson T, Sha S, Xiang YT. Worldwide prevalence of mild cognitive impairment among community dwellers aged 50 years and older: a meta-analysis and systematic review of epidemiology studies. Age Ageing. 2022 Aug 2;51(8):afac173. doi: 10.1093/ageing/afac173.

    PubMed 35977150
  • Landeiro F, Mughal S, Walsh K, Nye E, Morton J, Williams H, Ghinai I, Castro Y, Leal J, Roberts N, Wace H, Handels R, Lecomte P, Gustavsson A, Roncancio-Diaz E, Belger M, Jhuti GS, Bouvy JC, Potashman MH, Tockhorn-Heidenreich A, Gray AM; ROADMAP consortium. Health-related quality of life in people with predementia Alzheimer's disease, mild cognitive impairment or dementia measured with preference-based instruments: a systematic literature review. Alzheimers Res Ther. 2020 Nov 18;12(1):154. doi: 10.1186/s13195-020-00723-1.

    PubMed 33208190
  • Lin RSY, Yu DSF, Chau PH, Li PWC. Effects of an empowerment-based educative psycho-behavioral program on neuropsychiatric symptoms among persons with mild cognitive impairment: A mixed methods study. Int J Nurs Stud. 2023 Jan;137:104381. doi: 10.1016/j.ijnurstu.2022.104381. Epub 2022 Oct 14.

    PubMed 36402056
  • Sachs-Ericsson N, Blazer DG. The new DSM-5 diagnosis of mild neurocognitive disorder and its relation to research in mild cognitive impairment. Aging Ment Health. 2015 Jan;19(1):2-12. doi: 10.1080/13607863.2014.920303. Epub 2014 Jun 10.

    PubMed 24914889
  • Yang C, Moore A, Mpofu E, Dorstyn D, Li Q, Yin C. Effectiveness of Combined Cognitive and Physical Interventions to Enhance Functioning in Older Adults With Mild Cognitive Impairment: A Systematic Review of Randomized Controlled Trials. Gerontologist. 2020 Nov 23;60(8):633-642. doi: 10.1093/geront/gnz149.

    PubMed 31697831
  • Salzman T, Sarquis-Adamson Y, Son S, Montero-Odasso M, Fraser S. Associations of Multidomain Interventions With Improvements in Cognition in Mild Cognitive Impairment: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 May 2;5(5):e226744. doi: 10.1001/jamanetworkopen.2022.6744.

    PubMed 35503222
  • Christiansen L, Sanmartin Berglund J, Anderberg P, Cellek S, Zhang J, Lemmens E, Garolera M, Mayoral-Cleries F, Skar L. Associations Between Mobile Health Technology use and Self-rated Quality of Life: A Cross-sectional Study on Older Adults with Cognitive Impairment. Gerontol Geriatr Med. 2021 May 25;7:23337214211018924. doi: 10.1177/23337214211018924. eCollection 2021 Jan-Dec.

    PubMed 34104685

Questions about this trial

What is this clinical trial studying?

A study testing automated instant message-guided neuropsychiatric symptoms management and general mental health 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 May 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?

Contact Doris Sau Fung Yu, Professor (+852 3917 6319, dyu1@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MBI-C scores (time frame: at baseline, 10th week and 24th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07420426, which also lists 36 linked publications.

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 18 May 2026.

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