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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
  1. 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.
  2. 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.
  3. 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

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

      • Hong Kong, Hong Kong
        • The Education University of Hong Kong

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
Eksperimentell: Gruppe 2
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
Eksperimentell: Gruppe 1
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Perceived Stress
Tidsramme: baseline and immediately after intervention
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.
baseline and immediately after intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Depressive Symptoms
Tidsramme: baseline and immediately after intervention
Patient health questionnaire 9, items are rated on a 4-point scale, ranging from 0 to 27, with higher scores reflecting greater depression severity.
baseline and immediately after intervention
caregiving burden
Tidsramme: baseline and immediately after intervention
12-item Zarit Burden Interview, items are rated on a 5-point scale, ranging from 0-48, with higher scores denoting greater burden.
baseline and immediately after intervention
Positive Aspect of Caregiving
Tidsramme: baseline and immediately after intervention
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
baseline and immediately after intervention
sleep quality
Tidsramme: baseline and immediately after intervention
Pittsburgh Sleep Quality Index, score ranging from 0-21, with higher scores indicate poorer sleep quality.
baseline and immediately after intervention
quality of life
Tidsramme: baseline and immediately after intervention
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.
baseline and immediately after intervention
Mindfulness
Tidsramme: baseline and immediately after intervention
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.
baseline and immediately after intervention

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prompt-Specific Questions
Tidsramme: during and immediately after intervention
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
during and immediately after intervention
feasibility and acceptability rate of the app
Tidsramme: immediately after intervention
immediately after intervention
mindfulness intervention specific questions
Tidsramme: immediately after intervention
immediately after intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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