NCT05446909

Preventing Cognitive Decline

Completed NA Results posted Last updated 29 October 2024

What this trial tests

NA trial testing IBMT mindfulness in Cognitive Decline in 40 participants. Completed in 28 February 2023.

Timeline

1 February 2021

Primary endpoint
28 February 2023

28 February 2023

Quick facts

Lead sponsor	Arizona State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	40
Start date	1 February 2021
Primary completion	28 February 2023
Estimated completion	28 February 2023
Sites	1 location across United States

Drugs / interventions tested

• IBMT mindfulness
• health education

Conditions studied

• Cognitive Decline — all drugs for Cognitive Decline →

Sponsor

Arizona State University

Who can join

Adults 40 to 65, any sex, with Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Trials Correct On Working Memory Test Primary · 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.

Baseline

Group	Value	95% CI
IBMT Mindfulness	87.69	± 0.15
Health Education	91.57	± 0.14

Post-Intervention

Group	Value	95% CI
IBMT Mindfulness	88.01	± 0.16
Health Education	91.68	± 0.17

Intervention Effects on Cognitive Decline Primary · 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.

Baseline

Group	Value	95% CI
IBMT Mindfulness	5.34	± 1.18
Health Education	4.96	± 1.02

Post-Intervention

Group	Value	95% CI
IBMT Mindfulness	5.29	± 1.17
Health Education	4.87	± 1.03

Intervention Effects on Emotion Regulation Primary · 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.

Baseline

Group	Value	95% CI
IBMT Mindfulness	5.71	± 0.83
Health Education	5.23	± 1.12

Post-Intervention

Group	Value	95% CI
IBMT Mindfulness	5.50	± 1.21
Health Education	4.94	± 0.84

Intervention Effects on Mindfulness Primary · 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.

Baseline

Group	Value	95% CI
IBMT Mindfulness	2.92	± 0.29
Health Education	2.87	± 0.32

Post-Intervention

Group	Value	95% CI
IBMT Mindfulness	3.92	± 0.49
Health Education	3.39	± 0.50

Intervention Effects on Brain Function Secondary · The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).

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.

Baseline

Group	Value	95% CI
IBMT Mindfulness	0.47	± 0.31
Health Education	0.51	± 0.39

Post-intervention

Group	Value	95% CI
IBMT Mindfulness	0.53	± 0.33
Health Education	0.49	± 0.35

Intervention Effects on Brain White Matter Secondary · The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).

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.

Baseline

Group	Value	95% CI
IBMT Mindfulness	0.42	± 0.04
Health Education	0.39	± 0.05

Post-intervention

Group	Value	95% CI
IBMT Mindfulness	0.43	± 0.04
Health Education	0.37	± 0.04

Intervention Effects on Brain Grey Matter Secondary · The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).

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.

Baseline

Group	Value	95% CI
IBMT Mindfulness	589.23	± 69.3
Health Education	569.39	± 67.32

Post-intervention

Group	Value	95% CI
IBMT Mindfulness	570.42	± 62.11
Health Education	576.87	± 64.28

Sponsor's own description

The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.