Anxiety, Caregiver Burden, Stress
Conditions
Keywords
Heart Rate Variability, Biofeedback, Alzheimer's disease, Dementia
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHeart Rate Variability Biofeedback
Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week
BEHAVIORALMusic Listening Control
Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week
Sponsors
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
The participant is advised that they are entering a study in which they will be randomized to one of two conditions designed to potentially reduce stress and caregiver burden. Neither condition is presented as the control, thus participants are blinded to the expectations of the assigned condition.
Intervention model description
This is a two-arm parallel randomized controlled trial comparing heart rate variability biofeedback to a music listening control condition, both practiced 4-5 days per week for 8 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* In primary/unpaid FCG role \> 6 months * Caring for mild-to-severe ADRD patient * 4 caregiver burden score Own/operate smartphone w data plan
Exclusion criteria
* Pacemakers or implanted cardioconverter defibrillator (ICD), or conditions/meds that interfere with HRV measurement/feedback
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale-10 (PSS-10) | Change from baseline to 8 weeks at end of intervention | 10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress |
| Caregiver Burden | Change from baseline to 8 weeks at end of intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Brief Resilience Scale | Change from baseline to 8 weeks at end of intervention | The Brief Resilience Scale includes 4 items scoring 1-5, total score range, 4-20 with higher scores indicating higher resilience |
| Self-Compassion Scale | Change from baseline to 8 weeks at end of intervention | Self-Compassion Scale contains 12 items scoring 1-5, total score range, 12-60 with higher scores indicating higher self-compassion |
| Relationship Quality | Change from baseline to 8 weeks at end of intervention | 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 |
| Depression | Change from baseline to 8 weeks at end of intervention | Patient Health Questionnaire-4 (PHQ4) using 4 items scoring 0-3, total range 0-12 with higher scores indicating poor mood |
Countries
United States
Outcome results
None listed