- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420426
Instant Message-delivered Personalised Acceptance and Commitment Therapy (IMPACT) for Neuropsychiatric Symptoms in Persons With Mild Cognitive Impairment (IMPACT)
Instant Message-delivered Personalised Acceptance and Commitment Therapy (IMPACT) for Neuropsychiatric Symptoms in Persons With Mild Cognitive Impairment: a Mixed Methods Study
Study Overview
Status
Conditions
Detailed Description
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.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doris Sau Fung Yu, Professor
- Phone Number: +852 3917 6319
- Email: dyu1@hku.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Contact:
- Doris Sau Fung Yu, PhD
- Phone Number: +852 3917 6319
- Email: dyu1@hku.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
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 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).
|
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.
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|
Active Comparator: Control group
The 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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MBI-C scores
Time Frame: at baseline, 10th week and 24th week
|
The primary outcome will be MBI-C scores to assess NPSs.
A higher MBI-C scores will indicate a higher level of neuropsychiatric symptoms.
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at baseline, 10th week and 24th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms (PHQ-9)
Time Frame: at baseline, 10th week and 24th week
|
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.
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at baseline, 10th week and 24th week
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Anxiety symptoms (GAD-7)
Time Frame: at baseline, 10th week and 24th week
|
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom
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at baseline, 10th week and 24th week
|
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Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
Time Frame: at baseline, 10th week and 24th week
|
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).
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at baseline, 10th week and 24th week
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Cognitive functions (HK-MoCA)
Time Frame: at baseline, 10th week and 24th week
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The total score is calculated by summing up the score of all items.
Higher scores indicate better cognitive function.
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at baseline, 10th week and 24th week
|
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Acceptance of negative emotions and valued-based actions (AAQ-II)
Time Frame: at baseline, 10th week and 24th week
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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.
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at baseline, 10th week and 24th week
|
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Subjective Cognitive Decline scale (SCD-9)
Time Frame: at baseline, 10th week and 24th week
|
SCD-9 is a scale detecting subjective cognitive function.
Higher socre indicate worse subjective cognitive function.
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at baseline, 10th week and 24th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Doris Sau Fung Yu, Professor, School of Nursing, The University of Hong Kong
Publications and helpful links
General Publications
- GBD 2016 Dementia Collaborators. Global, regional, and national burden of Alzheimer's disease and other dementias, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):88-106. doi: 10.1016/S1474-4422(18)30403-4. Epub 2018 Nov 26.
- Jia L, Du Y, Chu L, Zhang Z, Li F, Lyu D, Li Y, Li Y, Zhu M, Jiao H, Song Y, Shi Y, Zhang H, Gong M, Wei C, Tang Y, Fang B, Guo D, Wang F, Zhou A, Chu C, Zuo X, Yu Y, Yuan Q, Wang W, Li F, Shi S, Yang H, Zhou C, Liao Z, Lv Y, Li Y, Kan M, Zhao H, Wang S, Yang S, Li H, Liu Z, Wang Q, Qin W, Jia J; COAST Group. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health. 2020 Dec;5(12):e661-e671. doi: 10.1016/S2468-2667(20)30185-7.
- Versluis A, Verkuil B, Spinhoven P, van der Ploeg MM, Brosschot JF. Changing Mental Health and Positive Psychological Well-Being Using Ecological Momentary Interventions: A Systematic Review and Meta-analysis. J Med Internet Res. 2016 Jun 27;18(6):e152. doi: 10.2196/jmir.5642.
- Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Herbert MS, Dochat C, Wooldridge JS, Materna K, Blanco BH, Tynan M, Lee MW, Gasperi M, Camodeca A, Harris D, Afari N. Technology-supported Acceptance and Commitment Therapy for chronic health conditions: A systematic review and meta-analysis. Behav Res Ther. 2022 Jan;148:103995. doi: 10.1016/j.brat.2021.103995. Epub 2021 Nov 12.
- Balaskas A, Schueller SM, Cox AL, Doherty G. Ecological momentary interventions for mental health: A scoping review. PLoS One. 2021 Mar 11;16(3):e0248152. doi: 10.1371/journal.pone.0248152. eCollection 2021.
- Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.
- Dindo L, Van Liew JR, Arch JJ. Acceptance and Commitment Therapy: A Transdiagnostic Behavioral Intervention for Mental Health and Medical Conditions. Neurotherapeutics. 2017 Jul;14(3):546-553. doi: 10.1007/s13311-017-0521-3.
- By the 2019 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria(R) for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019 Apr;67(4):674-694. doi: 10.1111/jgs.15767. Epub 2019 Jan 29.
- Yunusa I, Alsumali A, Garba AE, Regestein QR, Eguale T. Assessment of Reported Comparative Effectiveness and Safety of Atypical Antipsychotics in the Treatment of Behavioral and Psychological Symptoms of Dementia: A Network Meta-analysis. JAMA Netw Open. 2019 Mar 1;2(3):e190828. doi: 10.1001/jamanetworkopen.2019.0828.
- Cooper C, Sommerlad A, Lyketsos CG, Livingston G. Modifiable predictors of dementia in mild cognitive impairment: a systematic review and meta-analysis. Am J Psychiatry. 2015 Apr;172(4):323-34. doi: 10.1176/appi.ajp.2014.14070878. Epub 2015 Feb 20.
- Mourao RJ, Mansur G, Malloy-Diniz LF, Castro Costa E, Diniz BS. Depressive symptoms increase the risk of progression to dementia in subjects with mild cognitive impairment: systematic review and meta-analysis. Int J Geriatr Psychiatry. 2016 Aug;31(8):905-11. doi: 10.1002/gps.4406. Epub 2015 Dec 17.
- Hall GR, Buckwalter KC. Progressively lowered stress threshold: a conceptual model for care of adults with Alzheimer's disease. Arch Psychiatr Nurs. 1987 Dec;1(6):399-406. No abstract available.
- Dietlin S, Soto M, Kiyasova V, Pueyo M, de Mauleon A, Delrieu J, Ousset PJ, Vellas B. Neuropsychiatric Symptoms and Risk of Progression to Alzheimer's Disease Among Mild Cognitive Impairment Subjects. J Alzheimers Dis. 2019;70(1):25-34. doi: 10.3233/JAD-190025.
- Martin E, Velayudhan L. Neuropsychiatric Symptoms in Mild Cognitive Impairment: A Literature Review. Dement Geriatr Cogn Disord. 2020;49(2):146-155. doi: 10.1159/000507078. Epub 2020 Apr 14.
- Yatawara C, Hiu S, Tan L, Kandiah N. Neuropsychiatric symptoms in South-East Asian patients with mild cognitive impairment and dementia: prevalence, subtypes, and risk factors. Int J Geriatr Psychiatry. 2018 Jan;33(1):122-130. doi: 10.1002/gps.4693. Epub 2017 Feb 27.
- Kasper S, Bancher C, Eckert A, Forstl H, Frolich L, Hort J, Korczyn AD, Kressig RW, Levin O, Palomo MSM. Management of mild cognitive impairment (MCI): The need for national and international guidelines. World J Biol Psychiatry. 2020 Oct;21(8):579-594. doi: 10.1080/15622975.2019.1696473. Epub 2020 Feb 5.
- Elman JA, Jak AJ, Panizzon MS, Tu XM, Chen T, Reynolds CA, Gustavson DE, Franz CE, Hatton SN, Jacobson KC, Toomey R, McKenzie R, Xian H, Lyons MJ, Kremen WS. Underdiagnosis of mild cognitive impairment: A consequence of ignoring practice effects. Alzheimers Dement (Amst). 2018 May 14;10:372-381. doi: 10.1016/j.dadm.2018.04.003. eCollection 2018.
- Inui Y, Ito K, Kato T; SEAD-J Study Group. Longer-Term Investigation of the Value of 18F-FDG-PET and Magnetic Resonance Imaging for Predicting the Conversion of Mild Cognitive Impairment to Alzheimer's Disease: A Multicenter Study. J Alzheimers Dis. 2017;60(3):877-887. doi: 10.3233/JAD-170395.
- Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Practice guideline update summary: Mild cognitive impairment [RETIRED]: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Jan 16;90(3):126-135. doi: 10.1212/WNL.0000000000004826. Epub 2017 Dec 27.
- Liu CC, Liu CC, Kanekiyo T, Xu H, Bu G. Apolipoprotein E and Alzheimer disease: risk, mechanisms and therapy. Nat Rev Neurol. 2013 Feb;9(2):106-18. doi: 10.1038/nrneurol.2012.263. Epub 2013 Jan 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMPACT2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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