5Minutes4Myself Wellness Program for Caregiver Stress

Overseen By Elizabeth Larson, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Significant mental illness, others

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

Compensation: Varies

Number of Visits: 3

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study refines a wellness program designed for caregivers of autistic children called 5Minutes4Myself and further investigates its feasibility. Participants will attend a workshop to consent, participate in focus groups on lifestyle issues, and complete a baseline survey. Participants will have an individualized consultation with a coach to develop their tailored wellness program and be introduced to an app that support habits to build wellness activities into their daily life. The app provides the participant with their goal profile, tailored reminders, weekly check-ins, and delivers a micro-mindfulness program. Coaches will check-in monthly with participants and work together to modify their program as desired. After 4-6 months, participants will gather for a closing workshop to discuss their lifestyle and to evaluate the program. Pre-/post-surveys will examine health, well-being, stress, depression, and mindfulness. The app usability will be assessed using the Modified Systems Usability Scale (MSUS) as well as usage data.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment 5Minutes4Myself: A Wellness Program for Caregivers?

The research on similar wellness programs for caregivers, such as the Caregiver Wellness Self-Care program, shows that teaching strategies like mindfulness and self-care can help reduce caregiver stress and improve their well-being. This suggests that the 5Minutes4Myself program might also be effective in helping caregivers manage stress. ^{1 2 3 4 5}

Is the 5Minutes4Myself Wellness Program for Caregiver Stress safe for humans?

The research articles do not provide specific safety data for the 5Minutes4Myself Wellness Program, but similar wellness and self-care programs for caregivers, which include mindfulness and yoga practices, have been piloted without reported safety concerns. ^{2 4 6 7 8}

How is the 5Minutes4Myself treatment different from other treatments for caregiver stress?

The 5Minutes4Myself Wellness Program for Caregivers is unique because it focuses on providing quick, accessible wellness strategies specifically designed for caregivers, potentially offering a more flexible and time-efficient approach compared to longer, group-based programs like the Stress-Busting Program or the Caregiver Wellness Self-Care program. ^{2 4 9 10 11}

Research Team

Elizabeth Larson, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for primary caregivers of autistic children aged 8-21, or grandparents parenting grandchildren aged 5-21. Participants should have a desire to engage in a wellness program and be able to commit time to it. Those caring for children outside these age ranges or with significant mental illness (except treated depression) cannot join.

Inclusion Criteria

I care for a child with autism aged 8-21 or am a grandparent caring for a grandchild aged 5-21.

Primary caregivers for child with autism OR primary caregiver of grandchild

I am willing to dedicate the necessary time for this program.

Exclusion Criteria

I am a caregiver without major mental illness, except for treated depression.

I am a caregiver for a child with autism who is either under 8 or over 21, or I am a grandparent caring for a grandchild who is under 5 or over 21.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline Assessment and Program Introduction

Participants complete baseline surveys, participate in focus groups, and receive training on the wellness program and app usage

1-2 weeks

1 workshop (in-person or virtual)

Individualized Wellness Program

Participants engage in a tailored wellness program with monthly coaching sessions and app-based activities

4-6 months

Monthly coaching sessions (in-person or virtual), weekly app check-ins

Follow-up and Program Evaluation

Participants complete post-intervention surveys and participate in a closing workshop to evaluate the program

1-2 weeks

1 workshop (in-person or virtual)

Treatment Details

Interventions

• 5Minutes4Myself: A Wellness Program for Caregivers

Trial Overview The study tests the '5Minutes4Myself' wellness program, which includes motivational coaching and an app that helps build healthy habits. Caregivers will attend workshops, receive tailored programs, use the app for reminders and mindfulness exercises, and have monthly coach check-ins.

Participant Groups

Group I: Convenience sample participants Experimental Treatment 1 Intervention

In this feasibility study all participants will receive the intervention.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of a Caregiver's Education Program on Stroke Rehabilitation. [2022]

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

Caregivers of People With Disabilities: A Program to Enhance Wellness Self-Care. [2021]

3. 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]

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

Anticipating an Easier Day: Effects of Adult Day Services on Daily Cortisol and Stress. [2021]

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

Comparative Effectiveness of 2 Interventions for Hispanic Caregivers of Persons with Dementia. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

An online intervention to improve the health and well-being of informal caregivers of individuals with Alzheimer's disease: A pilot study. [2023]

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

The effect of video-based interventions on self-care. [2017]

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

A stress-busting program for family caregivers. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Description of a Multidimensional Health Program for Informal Caregivers]. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Care for the Caregivers: a program for Canadian military chaplains after serving in NATO and United Nations peacekeeping missions in the 1990s. [2017]