Feasibility of the Mindfulness Self-Compassionate Care program: a randomized controlled trial to address dementia
Ana-Maria Vranceanu1,2, Claire Szapary1,2, Maggie Crean2,3
1Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, Massachusetts, United States.
Background And Objectives:
We tested the feasibility and preliminary effects of the Mindfulness Self-Compassionate Care (MASC) program for dementia caregivers' stress triggered by the care recipients' neuropsychiatric symptoms.
Research Design And Methods:
Single-blind Stage 1B pilot randomized (2:1) controlled trial compared 6 weeks of MASC (n = 45) with a time and dose-matched education control (n = 23; Healthy Living for Caregivers [HLC]). T-tests examined within-group and between-group differences.
Results:
Most feasibility benchmarks were met. Mechanistic targets of mindfulness (p < .001; d = .58), self-compassion (p = .04; d = .32), self-efficacy (p < .001, d = .58), and distress from neuropsychiatric symptoms (p = .04, d = .33) showed small to medium pre-post improvements in the MASC group. Mechanistic validity was established through significant correlations between change in stress and change in mindfulness (r = -.58, p < .001), compassion (r = -.43, p = .003), self-compassion (r = -.77, p = <.000), self-efficacy (r = -.50, p = .001), and distress from dementia-related neuropsychiatric symptoms (r = .33, p = .03). Pre-post improvements in MASC were not statistically significantly different compared with HLC for stress (t (64) = -1.07, p = .29) or other outcomes.
Discussion And Implications:
The current study demonstrated feasibility and mechanistic target engagement and validity for MASC. As expected in an underpowered feasibility trial, clinical outcomes did not improve more than control, but trends favored MASC. These findings support a fully powered Stage 2 trial to test the efficacy of MASC compared with HLC.
Clinical Trial Registration Number:
NCT06276023.
