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MindWalk Intervention for Older South Asian Family Caregivers of People With IDD With Perceived Psychological Stress

Primary Purpose

Stress, Psychological, Cognitive Decline

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MindWalk Intervention
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress, Psychological focused on measuring Caregiver of a person with IDD, Perceived psychological stress, Cognitive Function, Mindful Walking, Physical Activity, Self-efficacy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Older South Asian family caregivers (50 years or older) caring for a person with IDD 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; having a score of < 24 out of a total score of 30 in the Mini Mental State Examination (MMSE) 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 50 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 Having a score of ≥ 24 out of a total score of 30 in the MMSE 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    MindWalk Intervention

    Control group

    Arm Description

    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 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.

    For the participants assigned to control group, there is no intervention. At the end of study, the control group participants will be given access to the recorded virtual mindful walking training only (this includes the 30 minutes introductory training and the weekly 10-minute mindfulness topics/modules).

    Outcomes

    Primary Outcome Measures

    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.
    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).
    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).

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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
    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

    Full Information

    First Posted
    July 20, 2023
    Last Updated
    August 16, 2023
    Sponsor
    University of Illinois at Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06002919
    Brief Title
    MindWalk Intervention for Older South Asian Family Caregivers of People With IDD With Perceived Psychological Stress
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 action 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 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.
    Detailed Description
    Older family caregivers, ages 50 and older of people with intellectual and/or developmental disabilities (IDD) 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 Intellectual and/or Developmental Disabilities (IDD) with Perceived Psychological Stress. Driven by a Community Advisory Committee (CAC) we will develop this 12-week mindful walking intervention using a participatory action 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Psychological, Cognitive Decline
    Keywords
    Caregiver of a person with IDD, Perceived psychological stress, Cognitive Function, Mindful Walking, Physical Activity, Self-efficacy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MindWalk Intervention
    Arm Type
    Active Comparator
    Arm Description
    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 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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    For the participants assigned to control group, there is no intervention. At the end of study, the control group participants will be given access to the recorded virtual mindful walking training only (this includes the 30 minutes introductory training and the weekly 10-minute mindfulness topics/modules).
    Intervention Type
    Behavioral
    Intervention Name(s)
    MindWalk Intervention
    Other Intervention Name(s)
    Mindful Walking Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Perceived Stress using the Acceptance and Action Questionnaire-II (AAQ-II)
    Description
    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.
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)
    Title
    Visuospatial inhibitory attention Using the NIH Toolbox Flanker Inhibitory Control and Attention Test
    Description
    Using the NIH Toolbox Flanker Inhibitory Control and Attention Test (for measuring attention and inhibitory control) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)
    Title
    Executive Functioning Using the NIH Toolbox Dimensional Change Card Sort Test
    Description
    Using the NIH Toolbox Dimensional Change Card Sort Test (for measuring executive function) from the NIH Toolbox Cognition Battery (HealthMeasures, 2020).
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)
    Secondary Outcome Measure Information:
    Title
    Physical Activity using International Physical Activity Questionnaire - Short (IPAQ-S) in MET-min/week
    Description
    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.
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)
    Title
    Physical Activity using Accelerometer to measure time spent on moderate-to-vigorous physical activity (MVPA)
    Description
    For physical activity measurement, participants will be asked to wear Accelerometers. Time spent on MVPA is measured.
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)
    Title
    Physical Activity using Accelerometer to measure step counts
    Description
    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.
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)
    Title
    Self-efficacy for coping with stress using Coping with Stress Self-Efficacy Scale (CSSES)
    Description
    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.
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)
    Title
    Self-Efficacy for Physical Activity using Self-Efficacy for Physical Activity (SEPA) scale
    Description
    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
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)
    Title
    Overall Self-Efficacy using the NIH ToolBox Emotion Battery on Self-Efficacy for Ages 18+
    Description
    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
    Time Frame
    Baseline, After 12 weeks and at follow up (20weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Older South Asian family caregivers (50 years or older) caring for a person with IDD 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; having a score of < 24 out of a total score of 30 in the Mini Mental State Examination (MMSE) 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 50 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 Having a score of ≥ 24 out of a total score of 30 in the MMSE 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sumithra Murthy
    Phone
    312-413-1647
    Email
    smurthy@uic.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sumithra Murthy
    Organizational Affiliation
    University of Illinois at Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    MindWalk Intervention for Older South Asian Family Caregivers of People With IDD With Perceived Psychological Stress

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