Pilot Randomized Controlled Trial of the Feasibility of a Mobile App-Delivered Mindfulness-Based Intervention for Caregiver Stress.

A mobile app-delivered mindfulness program for dementia caregivers (Healthy Minds Program for Caregivers) was feasible and acceptable in a pilot randomized trial with 95 participants. Feasibility benchmarks were met for enrollment, retention, and data collection. The intervention improved mindfulness and positive aspects of caregiving with large effects, and changes in these targets correlated with stress reduction. However, improvements in stress, depression, and anxiety were not statistically significant compared with an education podcast control, though trends favored the mindfulness program. A fully powered trial is warranted to test efficacy.

Study at a glance

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.