Effects of a closed-loop mindfulness-based program for reducing stress in family caregivers of people with dementia: a study protocol of a randomized controlled trial.

BACKGROUND

Mindfulness-based interventions (MBIs) have shown promise in reducing stress among family caregivers (FCs) of people with dementia (PWD). However, the long-term stress-relieving effects of traditional MBIs are often limited by challenges in maintaining regular practice, leading to issues with adherence and attrition. To address these limitations, this study protocol aims to test a novel closed-loop mindfulness-based program, integrated with a mobile application (Mind & Care App), to facilitate sustained mindfulness practice by providing quantifiable practice feedback and adaptive practice durations based on attentional capacity.

METHODS

This is a three-arm randomized controlled trial involving 189 FCs of PWD. Participants will be randomly assigned to one of three groups: (1) the closed-loop mindfulness-based program, (2) a traditional mindfulness program, or (3) a control group receiving brief education on dementia care. The closed-loop mindfulness program will consist of three weekly face-to-face training sessions (90 minutes each) and daily guided self-practice using the Mind & Care App over an 8-week period. Evaluations will occur at baseline, post-intervention, and at a 6-month follow-up. The primary outcome will be perceived stress, while secondary outcomes will include depressive symptoms, peace of mind, caregiving burden, dyadic relationship quality, dispositional mindfulness, heart rate variability, and the care recipients' neuropsychiatric symptoms. A process evaluation will examine whether dispositional mindfulness mediates the relationship between mobile app usage and stress reduction. A cost-effectiveness analysis will evaluate between-group differences in intervention costs relative to work productivity and activity impairment with caregiving activities. Focus group interviews will be conducted to explore the strengths, limitations, and therapeutic components of the intervention from the perspective of FCs.

DISCUSSION

This study will contribute to the understanding of how integrating quantifiable feedback and adaptive practice durations into mindfulness programs can enhance long-term mindfulness practice. By empowering FCs of PWD with mindfulness skills to manage the long-term challenges of caregiving, this intervention can improve caregiver well-being and caregiving outcomes.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT06880822. Registered on March 2025.