This study will examine a heart rate variability biofeedback (HRVB) intervention versus a music listening control (MLC) for 30 family caregivers (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 over the course of 8-weeks.
This pilot study aims to examine feasibility of implementing a HRVB intervention and an MLC control with AD FCGs. The HRVB and MLC interventions will be evaluated for acceptability (operationalized as adherence to intervention) and satisfaction and to identify necessary intervention modifications. Feasibility benchmarks: 85% of participants will be at least 70% adherent to implementation goals (10-min use 5-7 days per week). Feasibility of randomization will be examined by comparing adherence/retention (expecting similar patterns across interventions). Acceptability/satisfaction with HRVB and MLC will be evaluated in semi-structured interviews post-intervention including detailed probing on feature preferences, barriers/facilitators, suggested improvements for retention. The second aim of this study is to examine patterns of association of HRVB and MLC with outcomes. The investigators will examine pre- to post-intervention changes (and sustained outcomes at follow-up) in self-reported caregiver burden, stress and resilience. Change in relationship quality will additionally be assessed from pre- to post intervention. Change in ANS balance, a neurophysiological indicator of reduced emotional distress and improved resilience, will be assessed using HRV data at all four timepoints to examine trends and change over time. Significance tests will not be conducted, in alignment with goals for pilot feasibility studies. The investigators will observe the direction of change and outcomes to examine the value of MLC as an appropriate control condition showing minimal placebo effects compared to HRVB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
38
Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week
Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week
Arizona State University Downtown Campus
Phoenix, Arizona, United States
Perceived Stress Scale-10 (PSS-10)
10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress
Time frame: Change from baseline to 8 weeks at end of intervention
Caregiver Burden
The Zarit Burden Interview includes 12 items, scoring from 0 to 4 (total range 0 to 48) with higher scores indicating higher perceived caregiver Burden
Time frame: Change from baseline to 8 weeks at end of intervention
The Brief Resilience Scale
The Brief Resilience Scale includes 4 items scoring 1-5, total score range, 4-20 with higher scores indicating higher resilience
Time frame: Change from baseline to 8 weeks at end of intervention
Self-Compassion Scale
Self-Compassion Scale contains 12 items scoring 1-5, total score range, 12-60 with higher scores indicating higher self-compassion
Time frame: Change from baseline to 8 weeks at end of intervention
Relationship Quality
Relationship Quality for caregivers and their caregivee is assessed using 4 items scoring 1-4, total range, 5-20 with higher scores indicating better quality
Time frame: Change from baseline to 8 weeks at end of intervention
Depression
Patient Health Questionnaire-4 (PHQ4) using 4 items scoring 0-3, total range 0-12 with higher scores indicating poor mood
Time frame: Change from baseline to 8 weeks at end of intervention
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