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

Summary

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.

Conditions

• Dementia Caregiver

Interventions

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

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University

  collaborator OTHER

• Lingnan University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• Education University of Hong Kong

  lead OTHER

Principal Investigators

• Kee Lee Chou, PhD · The Education University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-18

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Hong Kong

Study Locations