Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2021-12-13
2023-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Music Listening Control
Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week
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.
Heart Rate Variability Biofeedback
Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week
Interventions
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Heart Rate Variability Biofeedback
Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week
Music Listening Control
Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Caring for mild-to-severe ADRD patient
* 4 caregiver burden score Own/operate smartphone w data plan
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Arizona State University
OTHER
Responsible Party
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Linda Larkey
Professor
Principal Investigators
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Linda K Larkey, PhD
Role: PRINCIPAL_INVESTIGATOR
Arizona State University
Locations
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Arizona State University Downtown Campus
Phoenix, Arizona, United States
Countries
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Other Identifiers
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00014913
Identifier Type: -
Identifier Source: org_study_id
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