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.
Patrick Pui Kin Kor, Kee Lee Chou, Alex Pak Lik Tsang, Winnie W. S. Mak, Julieta Galante, Rainbow Tin Hung Ho, Samuel Yeung Shan Wong, Daphne Sze Ki Cheung, Justina Yat Wa Liu, Steven H Zarit
BMC Psychology July 1, 2025 DOI: 10.1186/s40359-025-02919-2 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 189 |
| Population | Family caregivers of people with dementia |
| Interventions | closed-loop mindfulness-based program traditional mindfulness program brief education on dementia care |
| Duration | 8-week intervention, 6-month follow-up |
| Topics | Neuroplasticity Meditation |
| Keywords | Caregiving stress Closed-loop mindfulness Dementia care Family caregivers Mindfulness-based interventions Caregiver support Mindfulness interventions Randomized controlled trials |
| Citations | 2 |
| Registration | NCT06880822 |
| Key findings | The protocol describes a planned trial to test whether a closed-loop mindfulness program with adaptive practice durations and quantifiable feedback improves stress and other outcomes more than a traditional mindfulness program or education alone. |
Abstract
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. 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. 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. ClinicalTrials.gov, NCT06880822. Registered on March 2025.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 8
- The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology 2003
- How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective Perspectives on Psychological Science October 14, 2011
- 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. BMC Psychology October 21, 2024
- Mindfulness-based cognitive therapy for depression. Industrial Psychiatry Journal October 29, 2024
- Evaluating the effectiveness of a 6-week hybrid mindfulness-based intervention in reducing the stress among caregivers of patients with dementia during COVID-19 pandemic: protocol of a randomized controlled trial. BMC Psychology July 19, 2022
and 3 more in the library