COMPLETED

Development of Web-Based Mind-Body Trainings for Adults With Subjective Concerns

Conditions

Aging Focus Groups mindfulness-based stress reduction cognitive function mindfulness training subjective cognitive decline lifestyle education

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development of Online Mind-body Training Programs for Adults With Subjective Cognitive Decline

Quick Facts

Study Start:2024-11-01

Study Completion:2025-05-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06410807

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Ruchika Prakash, PhD

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

Department of Psychology, The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Ruchika Prakash, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2025-05-02

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2025-05-02

Terms related to this study

Keywords Provided by Researchers

mindfulness-based stress reduction
cognitive function
mindfulness training
aging
subjective cognitive decline
focus groups
lifestyle education

Additional Relevant MeSH Terms

Aging
Focus Groups