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Recruiting NCT07420426

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

No phase Interventional Mild Cognitive Impairment (MCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: automated instant message-guided neuropsychiatric symptoms management, general mental health management.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Behavioral automated instant message-guided neuropsychiatric symptoms management
    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.
  • Behavioral general mental health management
    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.

Primary outcome measures

  • MBI-C scores [Time frame: at baseline, 10th week and 24th week]
Secondary outcome measures (6)
  • Depressive symptoms (PHQ-9) [Time frame: at baseline, 10th week and 24th week]
  • Anxiety symptoms (GAD-7) [Time frame: at baseline, 10th week and 24th week]
  • Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L]) [Time frame: at baseline, 10th week and 24th week]
  • Cognitive functions (HK-MoCA) [Time frame: at baseline, 10th week and 24th week]
  • Acceptance of negative emotions and valued-based actions (AAQ-II) [Time frame: at baseline, 10th week and 24th week]
  • Subjective Cognitive Decline scale (SCD-9) [Time frame: at baseline, 10th week and 24th week]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • The University of Hong Kong — Hong Kong

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 25125421

Identifiers

NCT: NCT07420426 · IMPACT2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗