Closed-Loop and Neuroplasticity-Based Mindfulness Program for Family Caregivers

The aim of this study is to evaluate the effectiveness of a closed-loop and neuroplasticity-based mindfulness program for reducing stress among family caregivers of people with dementia. Participants will be randomly assigned to one of three groups: the closed-loop and neuroplasticity-based mindfulness program, a traditional mindfulness program, or brief education on dementia care. The closed-loop and neuroplasticity-based mindfulness program will include three weekly face-to-face training sessions (90 minutes each) and daily guided self-practice over 8 weeks via a mobile application. The traditional mindfulness program will not include the closed-loop approach but will feature general mindfulness practices with the same group size, duration, and frequency as the closed-loop program. The family caregivers in the control group will receive self-directed e-learning on dementia care with support from a registered nurse experienced in dementia care or elderly care, maintaining the same group size, duration, and frequency as the intervention groups. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). All groups will complete the same assessments at the same time points.

NCT Number	NCT06880822
Lead Sponsor	The Hong Kong Polytechnic University
Conditions	Caregiving Stress
Enrollment	189 participants
Start Date	2025-04-01
Primary Completion	2027-04 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2025-03-20