MindWalk Intervention for Older South Asian Caregivers of People With Cognitive Disabilities (CD)

NCT06002919 | Recruiting DMC

• 2 other identifiers: 2023-0337P30AG022849
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

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.

Conditions

Stress, Psychological; Cognitive Decline

Keywords

Caregiver of a person with cognitive disability; Perceived psychological stress; Cognitive Function; Mindful Walking; Physical Activity; Self-efficacy

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (6)

• Physical Activity using International Physical Activity Questionnaire - Short (IPAQ-S) in MET-min/week

  Baseline, After 12 weeks and at follow up (20weeks)

• Physical Activity using Accelerometer to measure time spent on moderate-to-vigorous physical activity (MVPA)

  Baseline, After 12 weeks and at follow up (20weeks)

• Physical Activity using Accelerometer to measure step counts

  Baseline, After 12 weeks and at follow up (20weeks)

• Self-efficacy for coping with stress using Coping with Stress Self-Efficacy Scale (CSSES)

  Baseline, After 12 weeks and at follow up (20weeks)

• Self-Efficacy for Physical Activity using Self-Efficacy for Physical Activity (SEPA) scale

  Baseline, After 12 weeks and at follow up (20weeks)

Study Arms (2)

MindWalk Intervention

ACTIVE COMPARATOR

12 week intervention: 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.

Behavioral: MindWalk Intervention

Control group

NO INTERVENTION

The participants in the control group will be provided with psychoeducation materials on benefits of walking without any components of mindfulness. The control group will receive neutral text messages with identical frequency and amount of messages that do not include motivational content or reminders related to mindful walking. At the end of study, the control group will also be given access to the recorded virtual mindful walking training (this includes the 30 minutes introductory training and the weekly 10-minute mindfulness topics/modules).

Interventions

MindWalk Intervention BEHAVIORAL

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.

Also known as: Mindful Walking Intervention

MindWalk Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (8)

American Association of Retired Asians

Bolingbrook, Illinois, 60440, United States

RECRUITING

Sanjeevani 4U

Buffalo Grove, Illinois, 60089, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Apna Ghar

Chicago, Illinois, 60613, United States

RECRUITING

South Asian American Policy & Research Institute

Chicago, Illinois, 60640, United States

RECRUITING

Metropolitan Asian Family Services

Chicago, Illinois, 60659, United States

RECRUITING

Hamdard Health Alliance

Chicago, Illinois, 60660, United States

RECRUITING

IL Department of Aging

Chicago, Illinois, 60661, United States

RECRUITING

MeSH Terms

Conditions

Stress, Psychological; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sumithra Murthy

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumithra Murthy

CONTACT

312-355-1396; smurthy@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 21, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (8)