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

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)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05383027

Acronym

CARES

Enrollment

Registered

2022-05-19

Start date

2022-02-01

Completion date

2022-12-31

Last updated

2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease and Related Dementias Family Caregivers

Brief summary

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.

Interventions

BEHAVIORALMusic Listening Control (MLC)

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.

BEHAVIORALHeart Focused Breathing

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactLinda K Larkey, PhD

linda.larkey@asu.edu6028212366

Backup ContactDara James, PhD

dara.james@asu.edu2074791440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026