Pilot Randomized Controlled Trial of the Feasibility of a Mobile App-Delivered Mindfulness-Based Intervention for Caregiver Stress.
Evan Plys, Morgan Seward, Elizabeth M Allen, Raquel G Tatar, Jennifer Huberty, Ana-Maria Vranceanu
The Gerontologist May 10, 2025 DOI: 10.1093/geront/gnaf047 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Pilot randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 95 |
| Population | Dementia caregivers |
| Duration | 12-week intervention |
| Topics | Meditation |
| Keywords | Caregiver stress Caregiving Mental health Pilot trial |
| Citations | 3 |
| Key findings | The mindfulness app was feasible and engaged mechanistic targets, but clinical outcomes did not significantly differ from a control condition. |
Abstract
We tested feasibility and preliminary benefits of a free mobile app-delivered mindfulness-based intervention for stress among dementia caregivers (i.e., Healthy Minds Program for Caregivers [HMP-C]). Single-blind Stage 1b pilot randomized controlled trial compared 12 weeks of HMP-C (n = 47) with a dose-matched education podcast control (n = 48; Wellness App [WA]). T-tests examined between-group differences. Feasibility benchmarks were met for acceptability (90% eligible enrolled), demand (95% completed post-tests), and data collection (100% measures complete). Treatment satisfaction was sufficient for HMP-C. Adherence was slightly lower than benchmarks (>52.5 minutes weekly) for HMP-C (67%) and WA (66%). Mechanistic targets of mindfulness (p < .001; d = -1.21) and positive aspects of caregiving (p < .001; d = -0.92) showed large pre-post improvements in the HMP-C group. Mechanistic validity was established through significant correlations between change in stress and change in mindfulness (r = -0.40, p = .006) and positive aspects of caregiving (r = -.49, p = .001). Pre-post improvements in HMP-C were not statistically significantly compared with WA for stress (p = .097; d = -0.35), depression (p = .110; d = -0.34), or anxiety (p = .237; d = -0.25). The current study demonstrated feasibility and mechanistic target engagement and validity for HMP-C. As expected in an underpowered feasibility trial, clinical outcomes did not improve more than control, but trends favored HMP-C. Together, findings demonstrate that a fully powered Stage 2 trial is warranted to test the efficacy of HMP-C compared with WA.
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 13
- The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials Perspectives on Psychological Science February 16, 2021
- Testing the Efficacy of a Multicomponent, Self-Guided, Smartphone-Based Meditation App: Three-Armed Randomized Controlled Trial JMIR Mental Health November 27, 2020
- The Effectiveness of Mindfulness- and Acceptance-Based Interventions for Informal Caregivers of People With Dementia: A Meta-Analysis The Gerontologist March 2, 2018
- Mindfulness training for psychological stress in family caregivers of persons with dementia: a systematic review and meta-analysis of randomized controlled trials Clinical Interventions in Aging September 1, 2017
- Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial. JMIR Research Protocols October 13, 2023
and 8 more in the library