Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurodegenerative Disorders
- Conditions
- Caregiver
- Registration Number
- NCT06583018
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
Over 80% of caregivers for individuals with neurodegenerative diseases (ND) engage in significant risk behaviors, particularly physical inactivity, which increases the risk of cardiometabolic diseases (CMD) by 30% and reduces life expectancy by 4-8 years. Despite the health benefits of maintaining healthy behaviors, awareness of behavioral risk management among healthcare professionals and the public is low, and research on this topic for ND caregivers is limited. Given that physical activity (PA) is the most prevalent modifiable risk factor, timely intervention is essential.
International guidelines prioritize PA as a key strategy for caregiver health. However, existing PA interventions often struggle with low compliance due to the physical and emotional challenges caregivers face. Our research group actively explores the health-regulating and enhancing effects of integrative mind-body modalities, particularly mindfulness, which may promote and sustain healthy behaviors by improving attentional regulation and psychological flexibility. Mindfulness-based lifestyle modification might help caregivers better manage physical discomfort, stress, and self-limiting beliefs, thereby supporting sustained PA.
The World Health Organization advocates for non-communicable disease (NCD) prevention through brief lifestyle interventions, such as ecological momentary interventions (EMI), which use mobile messaging (e.g., WhatsApp) to deliver personalized health content. This method is particularly valuable for caregivers who find it difficult to access traditional services due to their responsibilities.
This randomized clinical trial aims to evaluate the effects and acceptability of an EMI-enhanced "Brief and Blended Mindfulness-based Lifestyle Counselling Programme" (B-Mindful-Life) compared to brief lifestyle education for increasing PA among Chinese ND caregivers. The primary outcome will measure the change in accelerometer-determined, 10-minute bout moderate-to-vigorous physical activity (MVPA) over a 7-day period from baseline to post-intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 202
- adults who self-identify as the primary caregivers of ND patients for ≥3 months,
- experience of at least moderate stress as indicated by a PSS score ≥14,
- have a mobile device (e.g., smartphone, tablet, and laptop) with Internet access, and
- able to read and communicate in Chinese and give written consent
- a self-reported exercise regimen of great than 150 minutes/week of MVPA (according to the American College of Sports Medicine guidelines),
- have received (within the past 6 months) or are receiving other physical and/or psychosocial interventions,
- pregnancy or within 6 months of postpartum,
- contraindications (e.g., current diagnosis of psychiatric illness according to the DSM IV-TR, DSM-V, or ICD-10) or severe comorbidities (e.g., severe hearing/vision/cognitive impairment) that might limit full participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean change of time spent on 10-minute bout MVPA over a 7-day period Baseline and 2 months For caregivers only, measured by the accelerometer-based wristband activity tracker. The data will be considered valid if the participants wear the activity tracker for ≥10 hours/day for ≥5 days over a 7-day period.
- Secondary Outcome Measures
Name Time Method Mean change of time spent on 10-minute bout MVPA over a 7-day period Baseline and 5 months For caregivers only, measured by the accelerometer-based wristband activity tracker. The data will be considered valid if the participants wear the activity tracker for ≥10 hours/day for ≥5 days over a 7-day period.
Mean change of time spent on total MVPA over a 7-day period Baseline, 2 months, 5 months For caregivers only, measured by the accelerometer-based wristband activity tracker. The data will be considered valid if the participants wear the activity tracker for ≥10 hours/day for ≥5 days over a 7-day period.
Mean change of time spent on sporadic MVPA over a 7-day period Baseline, 2 months, 5 months For caregivers only, measured by the accelerometer-based wristband activity tracker. The data will be considered valid if the participants wear the activity tracker for ≥10 hours/day for ≥5 days over a 7-day period.
Mean change of average steps per day over a 7-day period Baseline, 2 month, 5 months For caregivers only, measured by the accelerometer-based wristband activity tracker. The data will be considered valid if the participants wear the activity tracker for ≥10 hours/day for ≥5 days over a 7-day period.
Health-related quality of life Baseline, 2 months, and 5 months For both caregivers and care recipients, measured by EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L). The questionnaire comprises two main components: a description of health status across 5 dimensions (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), and a numeric value representing the overall health status perceived by the respondents (EQ-VAS). Each dimension is rated from 0 (no problems) to 4 (extreme problems). The scores across the 5 dimensions will be transformed into a utility score based on a validated EQ-5D-5L value set for the Chinese population, with a higher utility score indicating a better health state.
The EQ-VAS records an individual's self-rated health on a numeric analogue visual scale, ranging from 0 (the worst health) to 100 (the best health).Self-reported level of physical activity Baseline, 2 months, and 5 months For caregivers only, measured by International Physical Activity Questionnaire - Short Form. Continuous scores will be calculated according to the standard scoring protocol, which transforms various physical activities into metabolic equivalent (MET)-minutes/week. A higher MET-minutes/week indicates a higher level of physical activity Based on the duration of different physical activities and the calculated MET-minutes/week, participants can also be classified into three categories: Low, Moderate, and High levels of physical activity.
Percieved stress level Baseline, 2 months, and 5 months For caregivers only, measured by Perceived Stress Scale. Each item is rated on a 0-4 scale (0=never, 4=very often). The total score ranges from 0-40. Higher score indicates higher level of stress. A total score ≥14 indicates moderate level of perceived stress, and a total score ≥27 indicates high level of perceived stress.
Caregiver burden Baseline, 2 months, and 5 months For caregivers only, measured by the 12-item Zarit Burden Interview - Short Version (ZBI-SV). Each item is rated on a 0-4 scale (0=Never, 4=Very Often). The total score ranges from 0-48. Higher score indicates heavier caregiver burden. Three domains of ZBI-SV perceived role strain, self-criticism, and negative emotion will also be assessed.
Anxiety Baseline, 2 months, and 5 months For caregivers only, measured by General Anxiety Disoder - 7 (GAD-7). Each item is rated on a 0-3 scale (0=not at all, 4=nearly every day). The total score ranges from 0-21. Higher score indicates higher level of anxiety. A total score ≥10 indicates possible anxiety.
Depression Baseline, 2 months, and 5 months For caregivers only, measured by Patient Health Questionnaire - 9 (PHQ-9). Each item is rated on a 0-3 scale (0=not at all, 4=nearly every day). The total score ranges from 0-27. Higher score indicates higher level of depression. A total score ≥10 indicates possible major depression.
Mindfulness Baseline, 2 months, and 5 months For caregivers only, measured by 20-item Five-facet Mindfulness Questionnaire - Short Form (FFMQ-SF). Each item is rated on 1-5 scale (1=Never, 5=Very Often). The total score ranges from 20-100. Higher score indicates higher level of trait mindfulness. In addition, five domains of the FFMQ-SF, namely observing, describing, acting with awareness, non-judgment of inner experience, and non-reaction to inner experience will be assessed.
Self-care behaviors Baseline, 2 months, and 5 months For caregivers only, measured by 20-item Self-Care Inventory (SCI). Each item is rated on a 1 to 5 scale (1=Never, 5=Always). 3 domains of the SCI, namely self-care maintenance, self-care monitoring, and self-care management will be assessed. The score of each domain is derived from the raw summative score using the scoring algorithm proposed by the scale developer, which ranges from 0 to 100. A higher score on the SCI indicates better engagement in self-care in the corresponding domain.
Self-care efficacy Baseline, 2 months, and 5 months For caregivers only, measured by the 10-item Self-Care Self-Efficacy Scale (SCSES). Each item is rated on a 1 to 5 scale (1=No Confident, 5=Extremely Confident). The total score ranges from 10-50. Higher score in SCSES indicates higher level of self-care efficacy.
Attention and meditation levels Baseline, 2 months, and 5 months For caregivers only, measured using a validated electroencephalogram-based headband tracker. Participants will wear the headband with assistance from the outcome assessor before following a standardized audio-guided protocol. Attention and meditation levels will be assessed using a 0-100 rating scale, where a higher score indicates increased focused attention and meditation status, respectively.
Support care needs Baseline, 2 months, and 5 months For care recipients only, meausred by the 10-item Palliative care Outcome Scale (POS). The 10 items assess physical symptoms, emotional, psychosocial and spiritual needs, provision of information and practical concerns. Each item is rated on a 0 - 4 scale (0=No burden, 4=Overwhelming problems). The total score ranges from 0-40. Higher score indicates greater unmet support care needs.
Trial Locations
- Locations (1)
School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
🇭🇰Pokfulam, Hong Kong