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

NCT05941143 | Completed

• 1 other identifier: 104/18
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (3)

• Change from baseline in dispositional mindfulness on the Five Facet Mindfulness (FFM) Scale at week 8

  FFM scale is a validated self-reported scale assessing dispositional mindfulness, with higher scores indicating higher mindfulness. Change=8 week score-baseline score.

  week 8

• Change from baseline in verbal memory on the California Verbal Learning Test (CVLT) at week 8

  CVLT is a validated word-list task assessing verbal memory, with higher scores indicating better verbal memory. Change=week 8 score-baseline score.

  week 8

• Change from baseline in interoceptive mindfulness on the Multidimensional Assessment of Interoceptive Awareness (MAIA) scale at week 8

  MAIA is a 32-item validated self-reported scale assessing interoceptive awareness, with higher scores indicating higher awareness. Change=8 week score-baseline score.

  week 8

Secondary Outcomes (1)

• Change from baseline EEG alpha power at week 8

  week 8

Other Outcomes (9)

• Change from baseline in emotion regulation strategies on the Emotion Regulation Questionnaire (ERQ) scale at week 8

  week 8

• Change from baseline in emotion regulation strategies on the Heidelberg Form for Emotion Regulation Strategies (HFERST) scale at week 8

  week 8

• Change from baseline in chronic worry on the Penn State Worry Questionnaire (PSWQ) at week 8

  week 8

Study Arms (1)

mindfulness-based intervention

EXPERIMENTAL

The intervention consist of 8 sessions in which participants learned three main different practices: body scan, sitting meditation, and yoga practice. Participants are instructed to regularly engage in home mindfulness practice of these new learned skills (45 minutes a day for 6 days a week). Home exercises include formal mindfulness practice (i.e., meditation and yoga) for about 30-35 minutes a day and informal practice focused on bringing mindful awareness to everyday activities for about 10-15 minutes a day. Mp3 audio of meditations proposed at each session are provided to guide personal practice.

Other: mindfulness-based intervention

Interventions

mindfulness-based intervention OTHER

8 weekly group 2-hour sessions program adapted from mindfulness-based stress reduction and mindfulness-based cognitive therapy protocols. It was specifically tailored to older adults.

mindfulness-based intervention

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• community-dwelling older adults
• age between 60 and 75 years
• normal cognition

You may not qualify if:

• clinically significant depression or anxiety
• major neurological disorders (i.e., stroke, dementia or cognitive impairment, tumor)
• major psychiatric disorders (i.e., major depressive disorder, bipolar disorder, drug and alcohol dependence)
• chronic disease or acute unstable illness (respiratory, cardiovascular, digestive, renal, metabolic, hematologic, endocrine, infectious, or malignancy) which interfered with the aims of the study protocol.

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

Location

Related Publications (1)

• Galluzzi S, Lanfredi M, Moretti DV, Rossi R, Meloni S, Tomasoni E, Frisoni GB, Chiesa A, Pievani M. Cognitive, psychological, and physiological effects of a web-based mindfulness intervention in older adults during the COVID-19 pandemic: an open study. BMC Geriatr. 2024 Feb 14;24(1):151. doi: 10.1186/s12877-024-04766-z.

  PMID: 38350854 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 12, 2023
• Study Start: September 11, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: July 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

IT (1)