Healthy AgingNCT05941143
Effect of Mindfulness on EEG Brain Activity for Cognitive and Psychological Well-being in the Elderly
A study testing mindfulness-based intervention in people with Healthy Aging, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- mindfulness-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteItaly
- Study dates
- 11 Sep 2019to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- community-dwelling older adults
- age between 60 and 75 years
- normal cognition
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Sixty older adults will be enrolled through local media announcements, meetings with elderly people organized in collaboration with local leisure and cultural associations, Alzheimer cafè, university of the third age, contacts with general practitioners. All participants will undergo cognitive and psychological evaluation and EEG. Moreover, current pharmacological therapies will be recorded and medical illness burden and comorbidity will be rated by the Cumulative Illness Rating Scale. Personality traits will be assessed by the Revised NEO Personality Inventory (NEO PI-R). The Subjective Cognitive Decline-Interview will be administered to evaluate the presence of subjective cognitive decline.
The EEG will be recorded (250 Hz sampling frequency, without filtering) with 19 standard electrodes positioned according to the international standard 10-20 in baseline conditions. The electrodes will have an impedance of less than 5 kiloohm. Recordings of 5 minutes with open eyes and 5 minutes with eyes closed will be performed. Following the acquisition of the signal, spectral analysis will be applied.
Mindfulness-based intervention is a standardized program which consists of 2-hour sessions that will be delivered at weekly intervals for 8 weeks in group setting. It is based on a comprehensive set of mindfulness practices derived from mindfulness-based stress reduction and mindfulness-based cognitive therapy programs, but specifically tailored to older adults. Participants will also be instructed to regularly engage in home mindfulness practice.
Follow-up: all participants will repeat cognitive and psychological evaluation and EEG after 2 weeks and after 24 weeks from the end of MBI.
Data analysis: Descriptive statistics on cognitive, psychological, and EEG variables will be done by using parametric and non- parametric tests. The analyses of correlation between different clinical variables (assessment tools) and EEG brain features will be assessed by linear and generalized linear models. For longitudinal analyses we will adopt the generalized estimating equation models.
- Conditions
- Healthy Aging
- Being tested
- mindfulness-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: mindfulness-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: week 8
Secondary outcomes (1)
Change from baseline EEG alpha power at week 8
alpha 1, alpha 2, alpha 3 bands
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start11 Sep 2019
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941143
- Sponsor's protocol ID
- 104/18
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset analyzed in this article is publicly available at the Mendeley data repository
Publications
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.
PubMed 38350854
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness on EEG Brain Activity for Cognitive and Psychological Well-being in the Elderly
- ClinicalTrials.gov ID
- NCT05941143
- Acronym / sponsor ID
- 104/18
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sixty older adults will be enrolled through local media announcements, meetings with elderly people organized in collaboration with local leisure and cultural associations, Alzheimer cafè, university of the third age, contacts with general practitioners. All participants will undergo cognitive and psychological evaluation and EEG. Moreover, current pharmacological therapies will be recorded and medical illness burden and comorbidity will be rated by the Cumulative Illness Rating Scale. Personality traits will be assessed by the Revised NEO Personality Inventory (NEO PI-R). The Subjective Cognitive Decline-Interview will be administered to evaluate the presence of subjective cognitive decline.
The EEG will be recorded (250 Hz sampling frequency, without filtering) with 19 standard electrodes positioned according to the international standard 10-20 in baseline conditions. The electrodes will have an impedance of less than 5 kiloohm. Recordings of 5 minutes with open eyes and 5 minutes with eyes closed will be performed. Following the acquisition of the signal, spectral analysis will be applied.
Mindfulness-based intervention is a standardized program which consists of 2-hour sessions that will be delivered at weekly intervals for 8 weeks in group setting. It is based on a comprehensive set of mindfulness practices derived from mindfulness-based stress reduction and mindfulness-based cognitive therapy programs, but specifically tailored to older adults. Participants will also be instructed to regularly engage in home mindfulness practice.
Follow-up: all participants will repeat cognitive and psychological evaluation and EEG after 2 weeks and after 24 weeks from the end of MBI.
Data analysis: Descriptive statistics on cognitive, psychological, and EEG variables will be done by using parametric and non- parametric tests. The analyses of correlation between different clinical variables (assessment tools) and EEG brain features will be assessed by linear and generalized linear models. For longitudinal analyses we will adopt the generalized estimating equation models.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based intervention | Experimental | Other: mindfulness-based interventionThe 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- community-dwelling older adults
- age between 60 and 75 years
- normal cognition
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based intervention8 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. | Other | mindfulness-based intervention |
Primary outcome
Change from baseline in dispositional mindfulness on the Five Facet Mindfulness (FFM) Scale at week 8
Time frame: 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.
Change from baseline in verbal memory on the California Verbal Learning Test (CVLT) at week 8
Time frame: 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.
Change from baseline in interoceptive mindfulness on the Multidimensional Assessment of Interoceptive Awareness (MAIA) scale at week 8
Time frame: 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.
1 secondary outcome
Change from baseline EEG alpha power at week 8
Time frame: week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 38350854Galluzzi 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.
- Individual participant dataSharing planned: Yes. The dataset analyzed in this article is publicly available at the Mendeley data repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based intervention in people with Healthy Aging, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in dispositional mindfulness on the Five Facet Mindfulness (FFM) Scale at week 8 (time frame: week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.