MindWalk Intervention for Older South Asian Caregivers of People With Cognitive Disabilities (CD)
MindWalk: A Mindful Walking Intervention for Older South Asian Family Caregivers of People With Cognitive Disabilities (CD) With Perceived Psychological Stress
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Sumithra Murthy
- Phone Number: 312-355-1396
- Email: smurthy@uic.edu
Study Locations
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Illinois
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Bolingbrook, Illinois, United States, 60440
- Recruiting
- American Association of Retired Asians
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Contact:
- Nazneen Saylawala
- Email: nsayla@gmail.com
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Buffalo Grove, Illinois, United States, 60089
- Recruiting
- Sanjeevani 4U
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Contact:
- Promila Kumar
- Email: promila.kumar11@gmail.com
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Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
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Contact:
- Namratha Kandula
- Email: n-kandula@northwestern.edu
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Chicago, Illinois, United States, 60613
- Recruiting
- Apna Ghar
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Contact:
- Radhika Sharma
- Email: rsharma@apnaghar.org
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Chicago, Illinois, United States, 60640
- Recruiting
- South Asian American Policy & Research Institute
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Contact:
- Shobhana Johri Verma
- Email: shobhana@saapri.org
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Chicago, Illinois, United States, 60659
- Recruiting
- Metropolitan Asian Family Services
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Contact:
- Santosh Kumar
- Email: santoshk@umasinc.com
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Chicago, Illinois, United States, 60660
- Recruiting
- Hamdard Health Alliance
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Contact:
- Kiran Siddiqui
- Email: ksiddiqui@hamdardhealth.org
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Chicago, Illinois, United States, 60661
- Recruiting
- IL Department of Aging
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Contact:
- Selma D'Souza
- Email: selma.dsouza@illinois.gov
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Active Comparator: MindWalk Intervention
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.
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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.
Other Names:
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No Intervention: Control group
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).
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perceived Stress using the Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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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.
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Baseline, After 12 weeks and at follow up (20weeks)
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Visuospatial inhibitory attention Using the NIH Toolbox Flanker Inhibitory Control and Attention Test
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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Using the NIH Toolbox Flanker Inhibitory Control and Attention Test (for measuring attention and inhibitory control) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).
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Baseline, After 12 weeks and at follow up (20weeks)
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Executive Functioning Using the NIH Toolbox Dimensional Change Card Sort Test
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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Using the NIH Toolbox Dimensional Change Card Sort Test (for measuring executive function) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).
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Baseline, After 12 weeks and at follow up (20weeks)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity using International Physical Activity Questionnaire - Short (IPAQ-S) in MET-min/week
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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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.
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Baseline, After 12 weeks and at follow up (20weeks)
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Physical Activity using Accelerometer to measure time spent on moderate-to-vigorous physical activity (MVPA)
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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For physical activity measurement, participants will be asked to wear Accelerometers.
Time spent on MVPA is measured.
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Baseline, After 12 weeks and at follow up (20weeks)
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Physical Activity using Accelerometer to measure step counts
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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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.
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Baseline, After 12 weeks and at follow up (20weeks)
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Self-efficacy for coping with stress using Coping with Stress Self-Efficacy Scale (CSSES)
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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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.
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Baseline, After 12 weeks and at follow up (20weeks)
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Self-Efficacy for Physical Activity using Self-Efficacy for Physical Activity (SEPA) scale
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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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
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Baseline, After 12 weeks and at follow up (20weeks)
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Overall Self-Efficacy using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+
Time Frame: Baseline, After 12 weeks and at follow up (20weeks)
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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
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Baseline, After 12 weeks and at follow up (20weeks)
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Sumithra Murthy, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2023-0337
- P30AG022849 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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