Clinical trial NCT06002919: MindWalk Intervention for Older South Asian Caregivers of People With Cognitive Disabilities (CD)
Official title: MindWalk: A Mindful Walking Intervention for Older South Asian Family Caregivers of People With Cognitive Disabilities (CD) With Perceived Psychological Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress, Psychological
Cognitive Decline
Keywords: Caregiver of a person with cognitive disability
Perceived psychological stress
Cognitive Function
Mindful Walking
Physical Activity
Self-efficacy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a a two-arm parallel assignment that involves two groups of participants. One group receives the MindWalk intervention, and the other group is the control group.
Primary purpose: OTHER

Brief summary: Older South Asian family caregivers experience elevated psychological stress and limited physical activity (PA) due to caregiving responsibilities and additional factors such as lack of access to services, cultural/linguistic barriers, stigma and discrimination. South Asian family caregivers are especially underserved and are a growing ethnic group in the US. Both PA and cognitive training (CT) have shown to improve cognitive function in older adults who experience cognitive function decline because of psychological stress. However, there are no studies using this approach for this population. We propose a randomized control trial pilot study to address this gap. Driven by a Community Advisory Committee (CAC) we will develop this 12-week mindful walking intervention using a participatory methodology in partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the PA of walking and the CT through mindfulness. We will recruit fifty participants and will randomly and equally assign 25 people to the intervention and 25 people to the control group. The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability. The primary aim of the proposed pilot study is to evaluate the feasibility and acceptability of the protocol and intervention implementation. A secondary aim will evaluate the intervention to examine preliminary efficacy in reduction of psychological stress, improvement in cognitive function, increase in physical activity, and increased self-efficacy (self-efficacy for coping with stress, self-efficacy for physical activity, and overall self-efficacy). The findings of this pilot project will provide evidence-based data to support a larger scale study proposal for future funding such as the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) field initiative award, or the National Institute of Health (NIH) Research Project Grant (R21 NIH Exploratory/Developmental Research Grant Award) award, especially National Institute on Aging (NIA) grants.

Detailed description: Older family caregivers, ages 45 and older of people with cognitive disabilities often experience high levels of stress and psychological distress which can result in cognitive decline. Both physical activity (PA) and cognitive training (CT) have shown to improve cognitive function in older adults who experience cognitive function decline because of psychological stress. There are some activities such as South Asian martial arts and yoga, that the South Asian community is familiar with, however there seems to be limited research incorporating mindful walking as an activity combining PA and CT. Specifically, mindful walking is a technique to learn to be more present and focused on the here and now while engaged in the physical activity of walking. Older South Asian family caregivers experience elevated psychological stress and limited physical activity due to caregiving responsibilities and additional factors such as lack of access to services, cultural and linguistic barriers, stigma and discrimination. South Asian family caregivers are especially underserved and are a growing ethnic group in the US. However, there are no studies using this approach for this population. We propose a randomized control trial pilot study to address this gap titled MindWalk: A Mindful Walking Intervention for Older South Asian Family Caregivers of People with Cognitive Disabilities with Perceived Psychological Stress. Driven by a Community Advisory Committee (CAC) we will develop this 12-week mindful walking intervention using a participatory research methodology in partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the physical activity of walking and the cognitive training through mindfulness. We will recruit fifty participants and will randomly and equally assign 25 people to the intervention and 25 people to the control group. The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability. The primary aim of the proposed pilot study is to evaluate the feasibility and acceptability of the protocol and intervention implementation. A secondary aim will evaluate the intervention to examine preliminary efficacy in reduction of psychological stress, improvement in cognitive function, increase in physical activity, and increased self-efficacy (self-efficacy for coping with stress, self-efficacy for physical activity, and overall self-efficacy). The findings of this pilot project will provide evidence-based data to support a larger scale study proposal for future funding such as the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) field initiative award, or the National Institute of Health (NIH) Research Project Grant (R21 NIH Exploratory/Developmental Research Grant Award) award, especially National Institute on Aging (NIA) grants.

Eligibility criteria: Inclusion Criteria:

* Older South Asian family caregivers (45 years or older) caring for a person with cognitive disability of any age
* Self-reported insufficient physical activity (defined as participating in moderate physical activity less than 60 min/week) and not engaged in mindfulness training
* Self-reporting of experiencing psychological stress;
* Own a smartphone with a data plan or Bluetooth-enabled device (e.g., tablets such as iPad) to sync data from the Fitbit tracker to the Fitbit app and to receive text messages
* Ability to speak, understand, read and write English; ability to provide informed consent

Exclusion Criteria:

* Non-South Asian caregivers
* Caregivers less than 45 years old
* Having self-reported sufficient physical activity (defined as participating in moderate physical activity more than 60 min/week) and engaged in some form of mindfulness training
* Not owning a smartphone with a data plan or Bluetooth-enabled device (e.g., tablets such as iPad)
* Mobility limitation
* Taking medications or other behavioral treatment for stress reduction; acute or chronic diseases at baseline
* Inability to understand, speak, read, and write English
* Inability to provide informed consent

Primary outcomes:
measure: Perceived Stress using the Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
measure: Visuospatial inhibitory attention Using the NIH Toolbox Flanker Inhibitory Control and Attention Test
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
measure: Executive Functioning Using the NIH Toolbox Dimensional Change Card Sort Test
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
Secondary outcomes:
measure: Physical Activity using International Physical Activity Questionnaire - Short (IPAQ-S) in MET-min/week
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
measure: Physical Activity using Accelerometer to measure time spent on moderate-to-vigorous physical activity (MVPA)
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
measure: Physical Activity using Accelerometer to measure step counts
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
measure: Self-efficacy for coping with stress using Coping with Stress Self-Efficacy Scale (CSSES)
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
measure: Self-Efficacy for Physical Activity using Self-Efficacy for Physical Activity (SEPA) scale
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
measure: Overall Self-Efficacy using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+
timeFrame: Baseline, After 12 weeks and at follow up (20weeks)
Other outcomes:
Locations:
city: Bolingbrook
country: United States
facility: American Association of Retired Asians
state: Illinois
city: Buffalo Grove
country: United States
facility: Sanjeevani 4U
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Apna Ghar
state: Illinois
city: Chicago
country: United States
facility: South Asian American Policy & Research Institute
state: Illinois
city: Chicago
country: United States
facility: Metropolitan Asian Family Services
state: Illinois
city: Chicago
country: United States
facility: Hamdard Health Alliance
state: Illinois
city: Chicago
country: United States
facility: IL Department of Aging
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sumithra Murthy
role: PRINCIPAL_INVESTIGATOR
References: