Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410807
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-01-11
Brief Title:
Development of Web-Based Mind-Body Trainings for Adults With Subjective Concerns
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Development of Online Mind-body Training Programs for Adults With Subjective Cognitive Decline
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iMBT
Brief Summary:
The goal of this observational study is to develop online self-paced mindfulness iMBSR and lifestyle education iLifeEd programs for adults with cognitive concerns Participants will engage in focus groups to discuss healthy living web-based behavioral interventions intervention contentformat and ideal outcomes after engaging in behavioral interventions that promote healthy living Additionally participants will provide feedback on the protocol and online platform for either iMBSR or iLifeEd This feedback will be used to refine the iMBSR and iLifeEd protocols for future use in the randomized controlled trial portion of the parent project
Detailed Description:
Rising prevalence rates of Alzheimers Disease AD have led to widespread interest in identifying individuals at-risk for AD and for developing interventions that delay or prevent the onset of AD Growing evidence suggests that subjective cognitive decline SCD-characterized by perceived persistent declines in cognitive functioning compared to previously normal cognitive status-may be a preclinical stage of Alzheimers Disease Individuals with SCD can be identified by self-reported declines in cognitive functioning based on self-report questionnaires such as the Everyday Cognition Questionnaire yet also exhibit normal performance based on age sex and education corrected standardized cognitive measures There is mounting evidence that mindfulness training traditionally offered as an 8-week in-person MBSR program improves cognitive functioning including in the investigators pilot MBSR trial with healthy older adults Further recent evidence from adults over the age of 60 has linked trait mindfulness with lower accumulation of AD pathology lower cognitive decline on measures of global cognition sustained attention and immediate and delayed memory Together this suggests that mindfulness training could be beneficial as a preventative training program in adults with SCD who have yet to show objective cognitive impairments However limited accessibility time and schedule constraints and travel logistics are among the greatest barriers for in-person MBSR programs Internet-based mindfulness programs are a promising and cost-effective approach but few studies have adapted MBSR for internet-delivery in an asynchronous format Several internet-based interventions ideographically tailored for the target population including acquired brain injury fibromyalgia and heart disease show promising support The present study seeks to address the urgent need for the development of alternative training programs that provide theoretical promise for reducing age-related cognitive decline demonstrate broad transfer effects to domains of cognitive functioning that directly impact everyday functioning and facilitate the development of a mechanistic model with easily identifiable and separable mechanisms The aim of the present study is to iteratively develop and refine internet-based MBSR iMBSR and internet-based lifestyle education iLifeEd protocols with a team of stakeholders ie focus groups Focus groups of adults with subjective cognitive decline will be recruited to iteratively develop and refine the platforms for the iMBSR and iLifeEd groups The iMBSR program will be a promising platform to deliver evidence-based mindfulness meditation techniques Additionally the iLifeEd program that will match the iMBSR program in terms of format of delivery duration of training peer support and homework assignment will be developed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None