Effect of a single-session mindfulness-based intervention for reducing stress in family caregivers of people with dementia: study protocol for a randomized controlled trial.

A single-session mindfulness-based intervention combined with app-based follow-up may reduce stress in family caregivers of people with dementia. This trial will test the effectiveness and feasibility of a 90-minute group session with mindfulness practices and psychoeducation, plus an 8-week self-practice toolkit and online sharing, compared to an education session on dementia care. The study is a single-blinded randomized controlled trial with assessments at baseline, 8 weeks, and 6 months. Primary outcome is perceived caregiving stress; secondary outcomes include depressive symptoms, positive aspects of caregiving, dyadic relationship, trait mindfulness, and neuropsychiatric symptoms of care recipients. Feasibility outcomes include eligibility, enrollment, attendance, adherence, and retention.

Study at a glance

Abstract

Caregiver stress can pose serious health and psychological concerns, highlighting the importance of timely interventions for family caregivers of people with dementia. Single-session mindfulness-based interventions could be a promising yet under-researched approach to enhancing their mental well-being within their unpredictable, time-constrained contexts. This trial will evaluate the effectiveness and feasibility of a blended mindfulness-based intervention consisting of a single session and app-based follow-up in reducing caregiver stress. The study is a single-blinded randomized controlled trial with two arms (intervention versus an education session on dementia care) and assessments at baseline, 8 weeks, and 6 months. The eligibility criteria include: family caregivers aged 18 years or older; providing care for an individual with a confirmed medical diagnosis of dementia for at least 3 months prior to recruitment, with a minimum of 4 hours of daily contact; and exhibiting a high level of caregiver stress. The intervention comprises a 90-minute group-based session with various mindfulness practices and psychoeducation. Participants will receive a self-practice toolkit to guide their practice over a duration of 8 weeks. Sharing activities will be implemented through an online social media platform. The primary outcome is perceived caregiving stress. The secondary outcomes include depressive symptoms, positive aspects of caregiving, dyadic relationship, trait mindfulness, and neuropsychiatric symptoms of care recipients. The feasibility outcomes include eligibility and enrollment, attendance, adherence to self-practice, and retention, assessed using mixed methods. The study will contribute to the evidence base by investigating whether a single-session mindfulness intervention is effective and feasible for reducing caregiver stress among family caregivers of people with dementia. ClinicalTrials.gov, NCT06346223. Registered on April 3, 2024.