NCT05941143

Effect of Mindfulness on EEG Brain Activity for Cognitive and Psychological Well-being in the Elderly

Completed NA Last updated 12 July 2023

What this trial tests

NA trial testing mindfulness-based intervention in Healthy Aging in 77 participants. Completed in 15 December 2021.

Timeline

11 September 2019

Primary endpoint
15 December 2021

15 December 2021

Quick facts

Lead sponsor	IRCCS Centro San Giovanni di Dio Fatebenefratelli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	77
Start date	11 September 2019
Primary completion	15 December 2021
Estimated completion	15 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• mindfulness-based intervention

Conditions studied

• Healthy Aging — all drugs for Healthy Aging →

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Who can join

Adults 60 to 75, any sex, with Healthy Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

As the worldwide population of older adults rapidly increases over the coming years, effective strategies are needed to help this population to maintain and enhance physical, cognitive, and psychological well-being. Up to 10% of community dwelling older adults have depressive symptoms in Europe. Older adults are also subject to chronic illnesses which further exacerbate psychological symptoms. Furthermore, normal aging is associated with decline in cognitive functioning. Given the prevalence of mental health problems and cognitive difficulties in older adults, mindfulness-based interventions (MBIs) could be helpful in this population. Accordingly, a growing number of studies suggest that mindfulness-based interventions in the elderly have beneficial effects on psychological health (decrease in depression, anxiety, sleep problems, and increase in general mood and positive affect) and cognition (enhanced attention, executive functions).

Electroencephalography (EEG) is a non-invasive technique which can be useful to study the neurophysiological correlates of mindfulness, and give neurobiological evidence of its beneficial effect in the elderly. Studies that examined spectral power outcomes between mindfulness and control state showed (i) increased alpha and theta power, as a marker of internally-directed attention processing and executive functioning and (ii) a shift towards left-sided anterior alpha activation, a pattern associated previously with positive emotions.

The aim of this study is to evaluate short and long-term cognitive, psychological, and physiological effects of a standard 8-week MBI in healthy older adults. Cognitive and psychological evaluations, and resting state EEG will be administered within 2 weeks prior to and within 2 weeks following MBI, and repeated 24 weeks following MBI.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cognitive, psychological, and physiological effects of a web-based mindfulness intervention in older adults during the COVID-19 pandemic: an open study.
   Galluzzi S, Lanfredi M, Moretti DV, Rossi R, et al · · 2024 · cited 6× · PMID 38350854 · DOI 10.1186/s12877-024-04766-z