- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07714681
Developing and Testing a Brief Mindfulness Just-in-time Adaptive Intervention for Reducing Stress of Dementia Caregivers
14 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
195
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Hong Kong, Hong Kong
- The Education University of Hong Kong
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Groupe 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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Expérimental: Groupe 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perceived Stress
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Depressive Symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Prompt-Specific Questions
Délai: 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
Délai: immediately after intervention
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immediately after intervention
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mindfulness intervention specific questions
Délai: immediately after intervention
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immediately after intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kee Lee Chou, PhD, The Education University of Hong Kong
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 novembre 2024
Achèvement primaire (Réel)
31 décembre 2025
Achèvement de l'étude (Réel)
31 décembre 2025
Dates d'inscription aux études
Première soumission
8 juillet 2026
Première soumission répondant aux critères de contrôle qualité
14 juillet 2026
Première publication (Réel)
20 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2021-2022-0276
- 20210051 (Autre subvention/numéro de financement: Health and Medical Research Fund)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .