Dementia Caregiver
Conditions
Brief 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.
Interventions
BEHAVIORALGroup 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
BEHAVIORALGroup 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
Education University of Hong Kong
The Hong Kong Polytechnic University
Lingnan University
Columbia University
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 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. |
| caregiving burden | 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. |
| Positive Aspect of Caregiving | 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 |
| sleep quality | baseline and immediately after intervention | Pittsburgh Sleep Quality Index, score ranging from 0-21, with higher scores indicate poorer sleep quality. |
| quality of life | 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. |
| Mindfulness | 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. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORKee Lee Chou, PhD
The Education University of Hong Kong
Outcome results
None listed