MindWalk Intervention for Older South Asian Caregivers of People With IDD

Stress, Psychological Clinical Trial

Official title:

MindWalk: A Mindful Walking Intervention for Older South Asian Family Caregivers of People With Intellectual and/or Developmental Disabilities (IDD) With Perceived Psychological Stress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002919
• Other study ID #: 2023-0337
• Secondary ID: P30AG022849
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: University of Illinois at Chicago
• Contact: Sumithra Murthy
• Phone: 312-413-1647
• Email: smurthy[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 research 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.

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 Charge HR) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Stress, Psychological

Intervention

Behavioral:
• MindWalk Intervention
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 Charge HR) 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.

Locations

Country	Name	City	State
United States	American Association of Retired Asians	Bolingbrook	Illinois
United States	Sanjeevani 4U	Buffalo Grove	Illinois
United States	Apna Ghar	Chicago	Illinois
United States	Hamdard Health Alliance	Chicago	Illinois
United States	IL Department of Aging	Chicago	Illinois
United States	Metropolitan Asian Family Services	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	South Asian American Policy & Research Institute	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress using the Acceptance and Action Questionnaire-II (AAQ-II)	Perceived stress will be measured using the Acceptance and Action Questionnaire-II (AAQ-II) scale, a 7-item scale (Bond et al., 2011). Higher total scores on the AAQ-II indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Lower total scores mean more psychological flexibility.	Baseline, After 12 weeks and at follow up (20weeks)
Primary	Visuospatial inhibitory attention Using the NIH Toolbox Flanker Inhibitory Control and Attention Test	Using the NIH Toolbox Flanker Inhibitory Control and Attention Test (for measuring attention and inhibitory control) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).	Baseline, After 12 weeks and at follow up (20weeks)
Primary	Executive Functioning Using the NIH Toolbox Dimensional Change Card Sort Test	Using the NIH Toolbox Dimensional Change Card Sort Test (for measuring executive function) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).	Baseline, After 12 weeks and at follow up (20weeks)
Secondary	Physical Activity using International Physical Activity Questionnaire - Short (IPAQ-S) in MET-min/week	For physical activity measurement, participants will complete International Physical Activity Questionnaire - Short (IPAQ-S). MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.	Baseline, After 12 weeks and at follow up (20weeks)
Secondary	Physical Activity using Accelerometer to measure time spent on moderate-to-vigorous physical activity (MVPA)	For physical activity measurement, participants will be asked to wear Accelerometers. Time spent on MVPA is measured.	Baseline, After 12 weeks and at follow up (20weeks)
Secondary	Physical Activity using Accelerometer to measure step counts	For physical activity measurement, participants will be asked to wear Accelerometers. Monitoring, step counts can serve as a proxy for the total volume of PA.	Baseline, After 12 weeks and at follow up (20weeks)
Secondary	Self-efficacy for coping with stress using Coping with Stress Self-Efficacy Scale (CSSES)	Self-efficacy for coping with stress will be measured using Coping with Stress Self-Efficacy Scale (CSSES) (Godoy-Izquierdo, Sola, García, 2011). The 8-item scale assesses efficacy and outcome expectations. This instrument consists of 8 items, 4 of which (items 2, 4, 5, and 7) assess the EE component, and the remaining 4 (items 1, 3, 6, and 8) assess the OE component. A global score (Total) is obtained by adding the EE and OE scores. Higher scores indicate greater confidence in one's skills for managing stress.	Baseline, After 12 weeks and at follow up (20weeks)
Secondary	Self-Efficacy for Physical Activity using Self-Efficacy for Physical Activity (SEPA) scale	Self-efficacy for physical activity will be measured using Self-Efficacy for Physical Activity (SEPA) scale (Marcus, Selby, Niaura, & Rossi, 1992). The Self-Efficacy for Physical Activity (SEPA) scale is a 5-item Likert measure that assesses an individual's confidence for engaging in exercise in the presence of barriers	Baseline, After 12 weeks and at follow up (20weeks)
Secondary	Overall Self-Efficacy using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+	Overall Self-efficacy for coping with stress will be measured using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+ (HealthMeasures, 2020) is a 10-item Likert scale with higher scores denoting better outcomes	Baseline, After 12 weeks and at follow up (20weeks)