CARES: Caring Relationships Expression Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Music Listening Control Music listening control (MLC) will consist of listening to selected music tracks of choice using either the Pandora or Spotify app (with coaching to download app and play, and log listening time in diary), specifically choosing a neutral channel, Coffeehouse Playlist. For both interventions, FCG will be asked to practice/listen 10-minutes at a time with their AD patient (sharing as much or as little as is possible/preferred) for at least 4-5 days/week, and asked to complete diary/checklists to show times practicing/listening. |
Behavioral: Music Listening Control
Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week
|
| Active Comparator: Heart Rate Variability Biofeedback Participants will receive coaching in a practice that is guided using an Inner Balance app with a device that senses pulse and provides feedback to help achieve a rhythm of heart rate variability called resonant frequency, or "coherence". They will be guided first in slowed heart-focused breathing and positively-focused emotions and then will connect to the app to receives visual feedback to achieve a favorable HRV. |
Behavioral: Heart Rate Variability Biofeedback
Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona State University Downtown Campus | Phoenix | Arizona | United States | 85004 |
Sponsors and Collaborators
- Arizona State University
Investigators
- Principal Investigator: Linda K Larkey, PhD, Arizona State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00014913