Developing and Testing a Brief Mindfulness Just-in-time Adaptive Intervention for Reducing Stress of Dementia Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Dementia Caregiver
• Intervention / Treatment: Behavioral: Group 1 - Vulnerability; Behavioral: Group 2 - Receptivity

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2	Behavioral: Group 2 - Receptivity; 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
Experimental: Group 1	Behavioral: Group 1 - Vulnerability; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	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	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	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	Pittsburgh Sleep Quality Index, score ranging from 0-21, with higher scores indicate poorer sleep quality.	baseline and immediately after intervention
quality of life	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prompt-Specific Questions	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		immediately after intervention
mindfulness intervention specific questions		immediately after intervention

Collaborators and Investigators

• Sponsor: Education University of Hong Kong
• Collaborators: Columbia University; The Hong Kong Polytechnic University; Penn State University; Lingnan University
• Investigators: Principal Investigator: Kee Lee Chou, PhD, The Education University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2021-2022-0276; 20210051 (Other Grant/Funding Number: Health and Medical Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No