Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurological Disorders

Official title

A Brief and Blended Mindfulness-based Lifestyle Counselling Programme (B-Mindful-Life) for Behavioural Risk Modification Among Caregivers of People With Neurodegenerative Disorders: A Randomised Controlled Trial

Overview

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. Mindfulness-based lifestyle modification might help caregivers better manage physical discomfort, stress, and self-limiting beliefs, thereby supporting sustained PA by improving attentional regulation and psychological flexibility. 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. A pilot RCT was conducted to compare B-Mindful-Life to brief lifestyle education program in Chinese neurodegenerative disease caregivers, demonstrating promising acceptability, engagement, and effect for increasing PA (NCT06583018). Therefore, this full-power randomized clinical trial aims to rigorously examine its effectiveness and broader impact on this underserved population with several advancement: (i) broaden the population into all neurological disorder caregivers to test for the generalizability of the B-Mindful-Life program; (ii) conduct a 12-month follow-up to assess long-term effects of B-Mindful-Life intervention in real-life settings; (iii) modify outcome measures for targeted assessment. 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.

Interventions

• Behavioral In-Person Mindfulness-based Group Sessions
  The 3-hour group-based session in week 1 focuses on experiential mindfulness practices, and a booster session in week 5 further consolidates these mindfulness techniques, reinforces mindful, healthy lifestyle, and provides peer support. Participants will enhance their self-awareness of positive, neutral, and negative body sensations, feelings, and thoughts while engaging in healthy behaviors, particularly physical activity.
• Behavioral Ecological Momentary Interventions (EMI)
  Participants will receive personalized instant messages with chat-based support throughout the 8-week intervention period. The message content is guided by existing international lifestyle modification guidelines and the Integrated Body-Mind-Spirit Model. The pre-set frequency of regular message delivery is five times per week. The schedule of message delivery will be personalized according to the participants' on-going needs/preferences over the intervention period. Chat-based support will be p
• Behavioral In-person Lifestyle Education Session
  A 3-hour group-based session in week 1 focused on general education on lifestyle modification based on the HEARTS technical package as recommended by the WHO, and will only receive reminder messages for the two assessment follow-ups. No chat-based support will be provided.
• Behavioral Activity Monitoring
  All participants will wear an accelerometer-based wristband activity tracker to monitor their physical activity in daily life.

Primary outcome measures

• Mean change of time spent on 10-minute bout MVPA over a 7-day period [Time frame: Baseline (T0) and 2 months (T1)]

Secondary outcome measures (12)

• Mean change of time spent on 10-minute bout MVPA over a 7-day period [Time frame: Baseline (T0), 6 months (T2), and 12 months (T3)]
• Mean change of time spent on total MVPA over a 7-day period [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Mean change of time spent on sporadic MVPA over a 7-day period [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Health-related quality of life [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Self-reported level of physical activity [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Negative emotions [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Caregiver burden [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Caregiving gains [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Mindfulness [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Self-care behaviors [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Self-care efficacy [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]
• Attention and meditation levels [Time frame: Baseline (T0), 2 months (T1), 6 months (T2), and 12 months (T3)]

Eligibility criteria

Inclusion criteria

• Adults who self-identify as the primary co-residing caregivers of ND patients for ≥3 months. ND is defined as any long-term disorder affecting the nervous system, such as stroke, epilepsy, multiple sclerosis, Parkinson's disease, Alzheimer's disease, traumatic brain injury, migraines, amyotrophic lateral sclerosis, and Huntington's disease;
• Experience of at least mild negative emotions, as indicated by DASS-21 score of Depression subscale ≥10, Anxiety subscale ≥8, or Stress subscale ≥15);
• 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.

Exclusion criteria

• 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; and
• Presence of contraindications, such as a current diagnosis of psychiatric illness (according to the DSM IV-TR, DSM-V, or ICD-10) or severe comorbidities (e.g., severe hearing, vision, or cognitive impairment) that might limit full participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Hong Kong · 1 center

• School of Nursing, LKS Faculty of Medicine, The University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07342140 · 23244201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗