- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07714681
Developing and Testing a Brief Mindfulness Just-in-time Adaptive Intervention for Reducing Stress of Dementia Caregivers
14. juli 2026 oppdatert av: Chou Kee Lee, Education University of Hong Kong
- To determine an effective decision rule for delivering brief mindfulness prompts as a function of caregivers' real-time stress state, including whether prompt delivery affects subsequent stress and affect and whether this effect varies by stress state at the decision point.
- To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending the current state of stress of caregivers and to examine if the adaptive model of machine learning algorithm generate higher receptivity of the brief intervention than the static and control model at the end of the four weeks.
- To evaluate the feasibility, acceptability, and preliminary effects of the brief mindfulness just-in-time adaptive intervention on perceived stress and related caregiver outcomes.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
195
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hong Kong, Hong Kong
- The Education University of Hong Kong
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- family dementia caregivers aged 18 above
- family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
- having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
- have a smartphone
- have moderate to high stress
Exclusion Criteria:
- Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
- Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Gruppe 2
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In the second phase, the receptivity of the brief mindfulness intervention will be examined within a just-in-time adaptive intervention (JITAI) framework, comprising distal outcomes, a proximal outcome (engagement with the brief intervention), decision points, intervention options (which notification-delivery model is applied), a tailoring variable (predicted receptivity), and decision rules.
In the first four days, as in the first phase, participants will be interviewed with a structured questionnaire and will receive a four-day psycho-education intervention.
Over the subsequent 14-day micro-randomized trial (Day 5 to Day 18), notification-delivery models will be randomized at scheduled daily decision points.
From Day 5 to Day 11, prompts will be delivered by either a random or a static machine-learning model with equal probability; from Day 12 to Day 18, prompts will be delivered by a random, static, or adaptive machine-learning model with equal probability, with the adaptive model u
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Eksperimentell: Gruppe 1
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In the first phase of the study, participants will be interviewed by a research assistant over the phone with a structured questionnaire on the first day of the study period.
They will then receive a four-day psycho-education intervention, during which the study application will be installed on their smartphone.
At the end of the fourth day, participants will be asked to use the app for the following 16 days of the micro-randomized trial (MRT).
In the 16-day MRT (Day 5 to Day 20), zero to six ecological momentary assessments (EMAs), separated by at least 30 minutes, will be delivered each day (from one hour after self-reported wake time to one hour before self-reported sleep time) to classify whether the participant is probably-stressed or probably-not-stressed using a single stress item.
Immediately following each EMA, participants will be randomized to receive a brief mindfulness intervention prompt or no prompt, with randomization occurring only if no brief mindfulness intervention
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Perceived Stress
Tidsramme: baseline and immediately after intervention
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14-item perceived stress scale.
Items are rated on a 5-point Likert scale, ranging from 0-56,with higher scores indicating greater perceived stress.
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baseline and immediately after intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Depressive Symptoms
Tidsramme: baseline and immediately after intervention
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Patient health questionnaire 9, items are rated on a 4-point scale, ranging from 0 to 27, with higher scores reflecting greater depression severity.
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baseline and immediately after intervention
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caregiving burden
Tidsramme: baseline and immediately after intervention
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12-item Zarit Burden Interview, items are rated on a 5-point scale, ranging from 0-48, with higher scores denoting greater burden.
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baseline and immediately after intervention
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Positive Aspect of Caregiving
Tidsramme: baseline and immediately after intervention
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Positive Aspects of Caregiving Scale, items are rated on a 5-point Likert scale, ranging from 9-45, with higher scores indicating a more positive appraisal
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baseline and immediately after intervention
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sleep quality
Tidsramme: baseline and immediately after intervention
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Pittsburgh Sleep Quality Index, score ranging from 0-21, with higher scores indicate poorer sleep quality.
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baseline and immediately after intervention
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quality of life
Tidsramme: baseline and immediately after intervention
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EuroQoL 5-Dimension 5-Level measures across 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), score ranging from 0-100, higher scores reflect better health-related quality of life.
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baseline and immediately after intervention
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Mindfulness
Tidsramme: baseline and immediately after intervention
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15-item Mindful Attention Awareness Scale, items are rated on a 6-point scale, score ranging from 1-6, with higher scores indicating greater dispositional mindfulness.
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baseline and immediately after intervention
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Prompt-Specific Questions
Tidsramme: during and immediately after intervention
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app backend records of post-prompt engagement with the brief intervention, including just-in-time response (engagement within the just-in-time window) and response delay; and single-item ecological momentary assessment ratings of stress, positive mood, and negative mood administered immediately following each completed intervention
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during and immediately after intervention
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feasibility and acceptability rate of the app
Tidsramme: immediately after intervention
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immediately after intervention
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mindfulness intervention specific questions
Tidsramme: immediately after intervention
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immediately after intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kee Lee Chou, PhD, The Education University of Hong Kong
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. november 2024
Primær fullføring (Faktiske)
31. desember 2025
Studiet fullført (Faktiske)
31. desember 2025
Datoer for studieregistrering
Først innsendt
8. juli 2026
Først innsendt som oppfylte QC-kriteriene
14. juli 2026
Først lagt ut (Faktiske)
20. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2021-2022-0276
- 20210051 (Annet stipend/finansieringsnummer: Health and Medical Research Fund)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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