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

NCT07714681 | Completed

• 2 other identifiers: 2021-2022-027620210051
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Dementia Caregiver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Depressive Symptoms

  baseline and immediately after intervention

• caregiving burden

  baseline and immediately after intervention

• Positive Aspect of Caregiving

  baseline and immediately after intervention

• sleep quality

  baseline and immediately after intervention

• quality of life

  baseline and immediately after intervention

Other Outcomes (3)

• Prompt-Specific Questions

  during and immediately after intervention

• feasibility and acceptability rate of the app

  immediately after intervention

• mindfulness intervention specific questions

  immediately after intervention

Study Arms (2)

Group 1

EXPERIMENTAL

Behavioral: Group 1 - Vulnerability

Group 2

EXPERIMENTAL

Behavioral: Group 2 - Receptivity

Interventions

Group 1 - Vulnerability BEHAVIORAL

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

Group 1

Group 2 - Receptivity BEHAVIORAL

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Education University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator
• Lingnan University: collaborator
• Columbia University: collaborator
• Penn State University: collaborator

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

• Kee Lee Chou, PhD

  The Education University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor of Social Policy

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: November 18, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)