Recruiting

HRVB & MLC

Sponsor:

Arizona State University

Code:

NCT05383027

Conditions

Alzheimer's Disease and Related Dementias Family Caregivers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Music Listening Control (MLC)

Heart Focused Breathing

Study Details

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.

Conditions

Alzheimer's Disease and Related Dementias Family Caregivers

Study ID

NCT05383027

Start date

Feb 1, 2022

Status verified date

May, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Music Listening Control(MLC)

experimental: Heart Focused Breathing

Interventions

Music 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.

Heart 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.

Primary outcome measure

  • Perceived Stress Scale-10 [ Time Frame: 13 weeks ]
  • Zarit Burden Interview [ Time Frame: 13 weeks ]
  • Brief Resilience Scale [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Linda K Larkey, PhD

6028212366linda.larkey@asu.edu

Dara James, PhD

2074791440dara.james@asu.edu

Locations

Arizona State University

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Linda K Larkey, PhD

602-821-2366linda.larkey@asu.edu

More Information

Sponsor

Arizona State University

Last update posted

May 19, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arizona State University on 2022-05-19.