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

Ruchika Shaurya Prakash, Stephanie Fountain-Zaragoza, Megan Fisher, Oyetunde Gbadeyan, Rebecca Andridge, Janice Kiecolt-Glaser, Heena R Manglani, Elizabeth J Duraney, Anita Shankar, Michael R McKenna, James Teng, Madhura Phansikar, Rosie Canter, Ruchika Shaurya Prakash, Stephanie Fountain-Zaragoza, Megan Fisher, Oyetunde Gbadeyan, Rebecca Andridge, Janice Kiecolt-Glaser, Heena R Manglani, Elizabeth J Duraney, Anita Shankar, Michael R McKenna, James Teng, Madhura Phansikar, Rosie Canter

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.

Keywords: Attentional control; Healthy aging; Mind-wandering; Mindfulness.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of the HealthyAgers Trial
Fig. 2
Fig. 2
Functional neuroanatomy of the sustained attention connectome-based predictive model (saCPM). A Presents the involvement of the ten canonical networks in the high attention model with edges representing functional connections that positively predict attentional control. Ribbons in the ring plot visualization are proportional to the representation of each network in the saCPM model. The matrix presented on the bottom shows the relative contribution of each network to the saCPM model adjusted using the formula described in Greene et al., 2019. Panel B highlights the network localization of the low attentonl model with edges representing functional connections that negatively predict attentional control. The matrix on the bottom shows the relative contribution of each network in the saCPM model. Chord diagrams were generated using the software Flourish (v7.0.0, https://app.flourish.studio)

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