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)

Arizona State University (ASU)

Status: Unknown

Conditions: Alzheimer's Disease and Related Dementias Family Caregivers

Treatments: Behavioral: Heart Focused Breathing; Behavioral: Music Listening Control (MLC)

Study type: Interventional

Funder types: Other

Identifiers

NCT05383027

000141913

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Music Listening Control(MLC)

Active Comparator group

Treatment:

Behavioral: Music Listening Control (MLC)

Heart Focused Breathing

Experimental group

Treatment:

Behavioral: Heart Focused Breathing