Pilot Randomized Controlled Trial of the Feasibility of a Mobile App-Delivered Mindfulness-Based Intervention for Caregiver Stress
Author: Evan Plys1,2, Morgan Seward1, Elizabeth M Allen1, Raquel G Tatar3, Jennifer Huberty4, Ana-Maria Vranceanu1,2
Affiliation:
1 Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, USA.
2 Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
3 Healthy Minds Innovations, Madison, WI, USA.
4 Fit Minded Inc., Phoenix, AZ, USA.
Conference/Journal: Gerontologist
Date published: 2025 Feb 8
Other:
Pages: gnaf047 , Special Notes: doi: 10.1093/geront/gnaf047. , Word Count: 238
Background and objectives:
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]).
Research design and methods:
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.
Results:
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 lower than benchmarks (>52.5 minutes weekly) for HMP-C (57%) and WA (59%). 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 =-.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).
Discussion and implications:
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.
Keywords: caregiver stress; caregiving; mental health; mindfulness; pilot trial.
PMID: 39921878 DOI: 10.1093/geront/gnaf047
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