Clinical trial NCT06410807: Development of Web-Based Mind-Body Trainings for Adults With Subjective Concerns
Official title: Development of Online Mind-body Training Programs for Adults With Subjective Cognitive Decline
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging
Focus Groups
Keywords: mindfulness-based stress reduction
cognitive function
mindfulness training
aging
subjective cognitive decline
focus groups
lifestyle education
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 50 years and over in the greater Columbus area with subjective cognitive decline

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 content/format 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 Alzheimer's 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 Alzheimer's 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 (i.e., 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.

Eligibility criteria: Inclusion Criteria:

* 50 years of age or older
* Report subjective cognitive decline with normatively intact performance on cognitive testing
* Capable of attending the assessment and the majority of focus group sessions
* Fluent English speaker
* Corrected (near and far) visual acuity of 20/40 or better
* Adequate hearing for experimental purposes
* Absence of diagnosed terminal illness
* Absence of diagnosed neurological disorders
* No history of psychotic disorder or substance abuse disorder
* Absence of any psychiatric disorder that was 1) diagnosed by a psychologist or psychiatrist and 2) diagnosed within the past 2 years OR symptoms and/or treatment is ongoing
* Absence of medication use that significantly alters brain activity
* No history of diagnosed learning disability that would interfere with the completion of cognitive tasks
* No evidence of mild cognitive impairment (MCI) or dementia: \>1 standard deviation (SD) below demographically adjusted normative mean on both measures of one domain OR \>1 SD below demographically adjusted normative mean on at least one measure of all three domains OR inadequate self-reported performance of instrumental activities of daily living
* Able to engage in light stretching exercises with or without assistive devices
* No regular practice of meditation or yoga (defined as once or more per week) AND no previous participation in a structured mindfulness class such as MBSR
* Access to the internet

Exclusion Criteria:

* Not 50 years of age or older
* Does not report subjective cognitive decline AND/ OR does not perform in the normatively intact range on cognitive testing
* Any physical limitation or pragmatic limitation that prohibits attendance at assessment and focus group sessions
* No fluency in English
* Corrected (near or far) visual acuity worse than 20/40
* Self-reported hearing impairment that would affect their ability to hear the experimenter
* Diagnosis of terminal illness
* Presence of diagnosed neurological disorders
* History of psychotic disorder or substance abuse disorder diagnosed by a psychologist or psychiatrist
* Presence of any psychiatric disorder that was 1) diagnosed by a psychologist or psychiatrist and 2) diagnosed within the past 2 years OR symptoms/treatment is ongoing
* Medication use that significantly alters brain activity
* History of diagnosed learning disability that would interfere with completion of the cognitive tasks
* Evidence of MCI or dementia: \>1 SD below demographically adjusted normative mean on both measures of one domain OR \>1 SD below demographically adjusted normative mean on at least one measure of all three domains OR inadequate self-reported performance of instrumental activities of daily living
* Actual or perceived limitation that prohibits engaging in light stretching exercises with or without assistive devices
* Any regular practice of meditation or yoga (defined as once or more per week) OR previous participation in a structured mindfulness class such as MBSR
* No access to the internet

Primary outcomes:
measure: Qualitative themes derived from focus group discussions on healthy living, web-based behavioral interventions, intervention content/format and ideal outcomes after engaging in behavioral interventions that promote healthy living
timeFrame: Baseline
measure: Qualitative themes derived from focus group discussions on perceptions of, attitudes toward, and feedback on initial intervention protocols
timeFrame: Baseline
measure: Qualitative themes derived from focus group discussions on perceptions of, attitudes toward, and feedback on fully developed web-based interface of the iMBSR and iLifeEd programs
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Department of Psychology, The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ruchika Prakash, PhD
role: PRINCIPAL_INVESTIGATOR
References: