Cognitive DeclineNCT05446909
Preventing Cognitive Decline
A study testing IBMT mindfulness and health education in people with Cognitive Decline, run by Arizona State University at 1 site in United States.
Trial summary
The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- IBMT mindfulness and health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read/understand English
- Normal performance using standardized cognitive tests
- Self-reported decline in cognitive capacity such as memory loss
- Eligible for non-invasive fMRI
- Willing to be randomized
- Free of any severe psychiatric diagnoses or medication that may affect participation
Who cannot join
- Medical disorders or medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
- Unable to provide consent or understand study procedures due to mental illness or cognitive limitations
- Previous meditation experiences
- Evidence of illicit drug use
- Participants for blood draws weigh less than 110 lbs
- Metal or metallic materials in the body such as pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation Effects of a Novel Body-mind Intervention on Subjective Cognitive Decline
The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.
Read the detailed description
Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is a risk factor for the cognitive decline and development of Alzheimer's (AD) and often happens in midlife. Recently, few mind-body interventions have suggested promising effects in preventing cognitive decline. However, these interventions often require longer training time (months to years) to achieve modest benefits, making them less optimal for rapidly learning and achieving desirable outcomes. One mechanism for cognitive decline and AD may involve deficits in self-control networks, and autonomic nervous system (ANS) and these deficits can be ameliorated through body-mind interventions. This study aims to investigate the modulation effects of a novel body-mind intervention on SCD using an evidence-based preventive intervention - integrative body-mind training (IBMT).
- Conditions
- Cognitive Decline
- Being tested
- IBMT mindfulness, health education
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBMT mindfulnessBehavioural
IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
health educationBehavioural
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
| Study group | Role | What they receive |
|---|---|---|
| IBMT mindfulness | Experimental | An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components. Receives: Behavioral: IBMT mindfulness |
| health education | Active comparator | Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Trials Correct On Working Memory Test
The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome.
Measured: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Cognitive Decline
The composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome.
Measured: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Emotion Regulation
The composite measures of executive function such as emotion regulation questionnaire; the minimum and maximum values (4 and 10); higher scores mean a better outcome.
Measured: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Mindfulness
The composite measures of executive function such as Five Facet Mindfulness Questionnaire; the minimum and maximum values (1 and 5); higher scores mean a better outcome.
Measured: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Secondary outcomes (3)
Intervention Effects on Brain Function
Changes in the strength of brain functional connectivity were measured by functional resting-state brain imaging. Higher numerical values represent stronger connectivity/better outcomes and lower values represent weaker connectivity/worse outcomes. Arbitrary units are used and the theoretical range of the values is from 0 to 1.
Measured: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Brain White Matter
Changes in AD-signature cortical brain white matter (i.e., level of fractional anisotropy) were measured by diffusion imaging. Higher numerical values represent higher white matter integrity/better outcomes and lower values represent lower white matter integrity/worse outcomes. Arbitrary units are used and the theoretical range of the values is from 0 to 1.
Measured: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Brain Grey Matter
Changes in AD-signature cortical grey matter volume were measured by MRI structural imaging. Higher numerical values represent greater grey matter volume/better outcomes and lower values represent lower grey matter volume/worse outcomes.
Measured: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Feb 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive DeclineStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- mindfulness vs. health education
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- YiYuan Tang, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446909
- Sponsor's protocol ID
- 2022 IBMT SCD
- Other IDs
- 3R61AT010138-03S1
- Status last verified
- Oct 2024
- First submitted
- 25 May 2022
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation Effects of a Novel Body-mind Intervention on Subjective Cognitive Decline
- ClinicalTrials.gov ID
- NCT05446909
- Acronym / sponsor ID
- 2022 IBMT SCD
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.
Detailed description
Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is a risk factor for the cognitive decline and development of Alzheimer's (AD) and often happens in midlife. Recently, few mind-body interventions have suggested promising effects in preventing cognitive decline. However, these interventions often require longer training time (months to years) to achieve modest benefits, making them less optimal for rapidly learning and achieving desirable outcomes. One mechanism for cognitive decline and AD may involve deficits in self-control networks, and autonomic nervous system (ANS) and these deficits can be ameliorated through body-mind interventions. This study aims to investigate the modulation effects of a novel body-mind intervention on SCD using an evidence-based preventive intervention - integrative body-mind training (IBMT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- mindfulness vs. health education
| Arm | Type | Receives |
|---|---|---|
| IBMT mindfulness | Experimental | Behavioral: IBMT mindfulnessAn evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components. |
| health education | Active comparator | Behavioral: health educationHealth education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to read/understand English
- Normal performance using standardized cognitive tests
- Self-reported decline in cognitive capacity such as memory loss
- Eligible for non-invasive fMRI
- Willing to be randomized
Key exclusion criteria (6 listed)
- Medical disorders or medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
- Unable to provide consent or understand study procedures due to mental illness or cognitive limitations
- Previous meditation experiences
- Evidence of illicit drug use
- Participants for blood draws weigh less than 110 lbs
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 |
|---|---|---|
| IBMT mindfulnessIBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management | Behavioural | IBMT mindfulness |
| health educationHealth education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle | Behavioural | health education |
Primary outcome
Percentage of Trials Correct On Working Memory Test
Time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome.
Intervention Effects on Cognitive Decline
Time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
The composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome.
Intervention Effects on Emotion Regulation
Time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
The composite measures of executive function such as emotion regulation questionnaire; the minimum and maximum values (4 and 10); higher scores mean a better outcome.
Intervention Effects on Mindfulness
Time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
The composite measures of executive function such as Five Facet Mindfulness Questionnaire; the minimum and maximum values (1 and 5); higher scores mean a better outcome.
3 secondary outcomes
Intervention Effects on Brain Function
Time frame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Brain White Matter
Time frame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Brain Grey Matter
Time frame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Recruiting
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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.
YiYuan Tang principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBMT mindfulness and health education in people with Cognitive Decline, run by Arizona State University at 1 site in United States.
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 6 inclusion and 6 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 29 Oct 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Trials Correct On Working Memory Test (time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.