Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study

Study Overview
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Brief Summary
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In a remotely delivered nationwide pilot study, we will be examining a novel 8-week heart rate variability biofeedback (HRVB) intervention vs music listening control (MLC) for 30 family caregivers 18 years and older (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality.

Official Title
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Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study(CARES)

Conditions
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Alzheimer's Disease and Related Dementias Family Caregivers

Intervention / Treatment
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* Behavioral: Music Listening Control (MLC)
* Behavioral: Heart Focused Breathing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and above primary, unpaid family caregiver for ADRD patient for 6 months or more owns and operates a smartphone with a data plan greater than of equal to 4 on caregiver burden scale Exclusion Criteria: regular mind-body practice under 18 years old pacemaker conditions or medications that interfere with heart rate variability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music Listening Control(MLC)<br> | Behavioral: Music Listening Control (MLC)<br>* MLC participants will engage in assigned music listening in the presence of their loved one with ADRD via a selected online platform (pandora or Spotify) for 10 minutes a day 5-7 days a week.<br>|
| Experimental: Heart Focused Breathing<br> | Behavioral: Heart Focused Breathing<br>* Heart-focused breathing participants will engage in heart-focused breathing using the inner balance device (shipped to their home), they will be asked to do this in the presence of their loved one with ADRD for 10 minutes a day 5-7 days per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale-10 | Measure of stress | 13 weeks | 
| Zarit Burden Interview | Measures participant burden | 13 weeks | 
| Brief Resilience Scale | Measures participant resillience | 13 weeks |