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

Not Applicable

• Conditions: Alzheimer's Disease and Related Dementias Family Caregivers

• Registration Number: NCT05383027
• Lead Sponsor: Arizona State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Last Update Submitted: 2022-05-17
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States