Protocol for a randomized controlled trial of mindfulness-based stress reduction to improve attentional control in older adults (HealthyAgers trial)

Abstract

Background Mindfulness meditation is a form of mind–body intervention that has increasing scientific support for its ability to reduce age-related declines in cognitive functioning, improve affective health, and strengthen the neural circuitry supporting improved cognitive and affective health. However, the majority of existent studies have been pilot investigations with small sample sizes, limited follow-up data, and a lack of attention to expectancy effects. Here, we present the study design of a Phase I/II, efficacy trial—HealthyAgers trial—that examines the benefits of a manualized mindfulness-based stress reduction program in improving attentional control and reducing mind-wandering in older adults. Methods One hundred fifty older adults (ages 65–85 years) will be randomized into one of two groups: an eight-week mindfulness program or an eight-week, placebo-controlled, lifestyle education program. Behavioral and neuroimaging assessments are conducted before and after the training. Participants are then invited to booster sessions once every three months for a period of 12 months with post-intervention follow-up assessments conducted at 6-months and 12-months. The primary outcomes for the study are behavioral measures of attentional control and mind-wandering. Additional, secondary outcomes include network strength in an a priori defined neuromarker of attentional control, fluid and everyday cognition, emotion regulation strategy use, and markers of inflammation. Discussion This study will establish the efficacy of a group-based, low-cost mind–body intervention for the inter-related facets of attentional control and mind-wandering in older adults. Strengths of this study include a well-designed, placebo-controlled comparison group, use of web/mobile application to track study adherence, and longitudinal follow-up. Trial registration Clinicaltrials.gov (#NCT03626532). Registered August 4, 2018.

The Role of Attentional Control in Mindfulness Intervention for Emotional Distress: A Randomized Controlled Trial With Longitudinal Mediation Analyses

“…Moreover, our findings indicate a significant enhancement in attentional control following the intervention, which was also significantly correlated with the MIED programme registration days. Consistent with several randomized control studies, the efficacy of 8-week mindfulness training interventions has been demonstrated in improving attentional control, manifested in improvements in momentary attentional control during daily life (Chin et al 2021), behavioural measures of attentional control (Prakash et al 2022) and electrophysiological markers of attentional control (Klee et al 2020;Moore et al 2012). Consequently, the MIED programme exhibits a pronounced impact on mitigating emotional distress (anxiety and depression levels) and enhancing attentional control, akin to other widely utilized MBIs.…”

“…2021), behavioural measures of attentional control (Prakash et al. 2022) and electrophysiological markers of attentional control (Klee et al. 2020; Moore et al.…”

Using connectome-based models of working memory to predict emotion regulation in older adults

“…The data used for the current study were collected as part of a randomized controlled trial designed to examine the effects of two mind-body interventions on attentional control in healthy older adults ( Prakash et al. , 2022 ).…”

“…Participants were initially recruited from the greater Columbus, Ohio area through a combination of advertisements and community outreach events. Detailed inclusionary and exclusionary criteria for the parent study have been published in the study protocol paper ( Prakash et al. , 2022 ).…”