Mindful Walking for Caregiver Stress

Recruiting at 7 trial locations

Overseen By Sumithra Murthy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Stress reduction medications

Disqualifiers: Non-South Asian, Under 45, Mobility limitation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, if you are taking medications for stress reduction, you will not be eligible to participate in this trial.

What data supports the effectiveness of the MindWalk Intervention treatment for caregiver stress?

Research shows that mindfulness-based interventions can help reduce stress and improve quality of life for caregivers. Studies have found that these interventions are feasible and can lead to significant improvements in mindfulness and stress reduction for caregivers, suggesting potential benefits for those participating in the MindWalk Intervention. ^{1 2 3 4 5}

Is mindful walking safe for caregivers?

Mindfulness-based interventions, which include mindful walking, are generally considered safe and have been shown to be acceptable and credible for caregivers, with no significant safety concerns reported in studies. ^{3 5 6 7 8}

How is the MindWalk Intervention treatment different from other treatments for caregiver stress?

The MindWalk Intervention is unique because it combines mindful walking, which is a form of mindfulness-based stress reduction (MBSR), with physical activity, offering a dual approach to reducing caregiver stress. This treatment is distinct from other mindfulness interventions that may not include a physical activity component, potentially enhancing both mental and physical well-being. ^{1 3 7 9 10}

Research Team

Sumithra Murthy

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for older South Asian family caregivers, aged 50 or above, who look after someone with IDD and are not very active physically (less than 60 minutes of moderate activity per week) and don't practice mindfulness. They should feel stressed, score below 24 on the MMSE test for cognitive function, own a smartphone or tablet to use the Fitbit app, and be able to communicate in English.

Inclusion Criteria

You possess a sufficient level of proficiency in English to comprehend the consent process and provide informed agreement.

You must possess a cellular-connected smartphone or Bluetooth-enabled device (e.g., iPad) to synchronize data from the Fitbit tracker and receive text notifications.

You have reported psychological stress, and achieved a score of 24 or lower on the Mini Mental State Examination.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindful Walking Training

Participants undergo mindful walking training as part of the intervention

1 week

1 visit (in-person or virtual)

Mindful Walking Regimen

Participants follow a prescribed mindful walking regimen, self-report adherence using logbooks and a PA tracker, and receive personalized text messages for motivation and accountability

12 weeks

Weekly check-ins (call or text)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of stress, cognitive function, and physical activity

8 weeks

2 visits (in-person or virtual)

Treatment Details

Interventions

• MindWalk Intervention

Trial Overview The study tests a 'MindWalk Intervention' combining physical activity through walking with cognitive training via mindfulness over a period of 12 weeks. Participants will be split into two groups: one will follow the mindful walking program while the other won't. The goal is to see if this helps reduce stress and improve both mental function and physical activity levels.

Participant Groups

Group I: MindWalk Intervention Active Control 1 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.

Group II: Control group Active Control 1 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).

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Written emotional disclosure showed a significant short-term reduction in caregiver burden, as measured by the Zarit Caregiver Burden Index, with a decline of -4.21 points at week 4 compared to control, although this effect diminished by week 8.

While overall distress and quality of life worsened for all groups, the written emotional disclosure group experienced the least worsening, suggesting it may be a beneficial strategy for managing caregiver distress in the context of advanced liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. Tapper, EB., Saleh, ZM., Lizza, S., et al.[2023]

An 8-week mindfulness-based intervention for caregivers of veterans was found to be feasible and well-accepted, with 100% retention of participants throughout the study.

The intervention led to significant improvements in four out of five facets of mindfulness compared to a waitlist control group, indicating its effectiveness in enhancing mindfulness among caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Mindfulness-Based Intervention for Caregivers of Veterans: A Pilot Study. Lara-Cinisomo, S., Fujimoto, EM., Santens, RL.[2020]

The dyadic intervention combining mindfulness-based stress reduction (MBSR) for caregivers and balance and progressive resistance training (PRT) for their loved ones significantly improved caregiver mindfulness and functional mobility in the loved ones, indicating potential benefits for both parties involved.

Despite these improvements, the intervention did not significantly reduce caregiver burden, suggesting that while mindfulness training is beneficial, additional strategies may be needed to address the challenges faced by caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Informal Dementia Caregivers and Their Loved Ones Via the HOMeCARE Exercise and Mindfulness for Health Program (HOMeCARE): A Randomized, Single-Blind, Controlled Trial. Lang, T., Daniel, K., Inskip, M., et al.[2023]

The Mindful Stress Reduction in Diabetes Education (Mind-STRIDE) program, a mindfulness-based intervention for veterans, showed high satisfaction rates among participants and educators, with 71% of veterans completing the study.

Participants experienced significant improvements in diabetes-related outcomes, including reduced diabetes distress and better self-management behaviors, suggesting that mindfulness practices can positively impact diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindful Approach to Diabetes Self-Management Education and Support for Veterans. DiNardo, M., Saba, S., Greco, CM., et al.[2022]

Mindfulness-based interventions (MBIs) are generally well-accepted and show medium to large positive effects on psychosocial outcomes for patients with dementia and mild cognitive impairment, while effects on cognitive functioning are smaller.

Caregivers of patients with dementia also benefit from MBIs, experiencing significant reductions in stress and improvements in quality of life, although the overall confidence in these findings is limited due to methodological inconsistencies across the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness-Based Interventions for Patients with Mild Cognitive Impairment or Dementia and Caregivers. Shim, M., Tilley, JL., Im, S., et al.[2021]

The study aims to develop and test a user-friendly stress management toolkit for people living with dementia and their care partners, using simple, nonpharmacologic tools like animatronic pets and aromatherapy, to help manage stress effectively.

By employing a human-centered design approach and involving dementia caring dyads in the co-design process, the intervention is expected to be more acceptable and feasible for real-world use, with preliminary data supporting its potential for implementation in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. Harris, M., Van Houtven, C., Hastings, S.[2022]

A randomized controlled trial is underway to assess the feasibility and effectiveness of the Healthy Minds Program (HMP) mobile app in reducing stress and emotional distress among caregivers of individuals with Alzheimer's disease and related dementias, with 80 caregivers expected to participate over 12 weeks.

Preliminary enrollment has begun, with 27 caregivers enrolled as of June 2023, indicating the potential for HMP to be a cost-effective intervention that improves caregiver health and quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial. Woodworth, EC., Briskin, EA., Plys, E., et al.[2023]

This pilot study successfully recruited family caregivers of dementia patients for a randomized controlled trial of mindfulness-based stress reduction, exceeding recruitment goals and achieving a high retention rate of 92% at 2 months and 90% at 6 months.

The study highlights that innovative recruitment strategies, such as outreach to health plan members and press coverage, can effectively address challenges in engaging caregivers, despite barriers like cultural perceptions and time commitments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruiting and retaining family caregivers to a randomized controlled trial on mindfulness-based stress reduction. Whitebird, RR., Kreitzer, MJ., Lewis, BA., et al.[2021]

A pilot study involving 64 family caregivers of frail older adults showed that an 8-week social media-based mind-body intervention, which included mindfulness meditation and self-administered acupressure, significantly reduced caregiver stress and improved sleep quality and mindfulness awareness compared to a control group.

The intervention demonstrated high feasibility with an 87.5% attendance rate and low attrition (1.6%), indicating that it is a practical and engaging option for caregivers, although it did not significantly reduce caregiver burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Social Media-Based Mind-Body Intervention Embedded With Acupressure and Mindfulness for Stress Reduction Among Family Caregivers of Frail Older Adults: Pilot Randomized Controlled Trial. Sui, Y., Kor, PPK., Li, M., et al.[2023]

Mindfulness-based stress reduction has been shown to effectively improve psychological symptoms such as stress, depression, and anxiety in family caregivers of patients with various conditions.

This approach is considered safe and easily accessible, making it a promising option for enhancing the mental well-being of caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Mindfulness-Based Stress Reduction for Family Caregivers: Systematic Review. Li, G., Yuan, H., Zhang, W.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Mindfulness-Based Intervention for Caregivers of Veterans: A Pilot Study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Caring for Informal Dementia Caregivers and Their Loved Ones Via the HOMeCARE Exercise and Mindfulness for Health Program (HOMeCARE): A Randomized, Single-Blind, Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Mindful Approach to Diabetes Self-Management Education and Support for Veterans. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness-Based Interventions for Patients with Mild Cognitive Impairment or Dementia and Caregivers. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Recruiting and retaining family caregivers to a randomized controlled trial on mindfulness-based stress reduction. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Effects of a Social Media-Based Mind-Body Intervention Embedded With Acupressure and Mindfulness for Stress Reduction Among Family Caregivers of Frail Older Adults: Pilot Randomized Controlled Trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The Effects of Mindfulness-Based Stress Reduction for Family Caregivers: Systematic Review. [2018]