OBJECTIVES: The objectives of this study were to evaluate whether a mindfulness meditation intervention may be effective in caregivers of close relatives with dementia and to help refine the protocol for future larger trials. DESIGN: The design was a pilot randomized trial to evaluate the effectiveness of a mindfulness meditation intervention adapted from the Mindfulness-Based Cognitive Therapy program in relation to two comparison groups: an education class based on Powerful Tools for Caregivers serving as an active control group and a respite-only group serving as a pragmatic control. SETTINGS/LOCATION: This study was conducted at the Oregon Health & Science University, Portland, OR. SUBJECTS: The subjects were community-dwelling caregivers aged 45-85 years of close relatives with dementia. INTERVENTIONS: The two active interventions lasted 7 weeks, and consisted of one 90-minute session per week along with at-home implementation of knowledge learned. The respite-only condition provided the same duration of respite care that was needed for the active interventions. OUTCOME MEASURES: Subjects were assessed prior to randomization and again after completing classes at 8 weeks. The primary outcome measure was a self-rated measure of caregiver stress, the Revised Memory and Behavior Problems Checklist (RMBPC). Secondary outcome measures included mood, fatigue, self-efficacy, mindfulness, salivary cortisols, cytokines, and cognitive function. We also evaluated self-rated stress in the subjects' own environment, expectancy of improvement, and credibility of the interventions. RESULTS: There were 31 caregivers randomized and 28 completers. There was a significant effect on RMBPC by group covarying for baseline RMBPC, with both active interventions showing improvement compared with the respite-only group. Most of the secondary outcome measures were not significantly affected by the interventions. There was an intervention effect on the caregiver self-efficacy measure and on cognitive measures. Although mindfulness was not impacted by the intervention, there were significant correlations between mindfulness and self-rated mood and stress scores. CONCLUSIONS: Both mindfulness and education interventions decreased the self-rated caregiver stress compared to the respite-only control.