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Stress, PsychologicalNCT06002919

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

A study testing MindWalk Intervention in people with Stress, Psychological and Cognitive Decline, run by University of Illinois Chicago at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Stress, Psychological, Cognitive Decline
What is being tested?
MindWalk Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
8 sitesUnited States
Study dates
31 Oct 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sumithra Murthy contact

312-355-1396

smurthy@uic.edu

8 sites in 1 country

United States8 sites, 8 recruiting
  • American Association of Retired Asians

    Bolingbrook, Illinois, 60440

    Nazneen Saylawala, nsayla@gmail.com

    Recruiting
  • Sanjeevani 4U

    Buffalo Grove, Illinois, 60089

    Promila Kumar, promila.kumar11@gmail.com

    Recruiting
  • Northwestern University

    Chicago, Illinois, 60611

    Namratha Kandula, n-kandula@northwestern.edu

    Recruiting
  • Apna Ghar

    Chicago, Illinois, 60613

    Radhika Sharma, rsharma@apnaghar.org

    Recruiting
  • South Asian American Policy & Research Institute

    Chicago, Illinois, 60640

    Shobhana Johri Verma, shobhana@saapri.org

    Recruiting
  • Metropolitan Asian Family Services

    Chicago, Illinois, 60659

    Santosh Kumar, santoshk@umasinc.com

    Recruiting
  • Hamdard Health Alliance

    Chicago, Illinois, 60660

    Kiran Siddiqui, ksiddiqui@hamdardhealth.org

    Recruiting
  • IL Department of Aging

    Chicago, Illinois, 60661

    Selma D'Souza, selma.dsouza@illinois.gov

    Recruiting

Other trials in United States

About this study

Official title: MindWalk: A Mindful Walking Intervention for Older South Asian Family Caregivers of People With Cognitive Disabilities (CD) With Perceived Psychological Stress

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.

Read the 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.

Being tested
MindWalk Intervention
Keywords
Caregiver of a person with cognitive disability, Perceived psychological stress, Cognitive Function, Mindful Walking, Physical Activity, Self-efficacy
Medical subject headings
Stress, Psychological, Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MindWalk InterventionBehavioural

    Also called Mindful Walking 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) 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.

Study groups in NCT06002919
Study groupRoleWhat they receive
MindWalk InterventionActive comparator12 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.
Receives: Behavioral: MindWalk Intervention
Control groupNo interventionThe 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

  3. 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).

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

Secondary outcomes (6)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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

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

  6. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start31 Oct 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002919
Sponsor's protocol ID
2023-0337
Other IDs
P30AG022849
Status last verified
Apr 2026
First submitted
20 Jul 2023
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing MindWalk Intervention in people with Stress, Psychological and Cognitive Decline, run by University of Illinois Chicago at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sumithra Murthy (312-355-1396, smurthy@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress using the Acceptance and Action Questionnaire-II (AAQ-II) (time frame: Baseline, After 12 weeks and at follow up (20weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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