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Completed

NCT Number: NCT05627687

Caring Relationships Expression Study

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.

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Key information

Conditions

Caregiver Burden Alzheimer Disease Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stress Stress, Psychological Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Arizona State University Downtown Campus

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart rate variability biofeedback

Behavioral

Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week

Other names: Heart Focused breathing

Music Listening Control

Behavioral

Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week

Primary outcomes

  1. Perceived Stress Scale-10 (PSS-10)

    Time frame: 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

  2. Caregiver Burden

    Time frame: 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 outcomes

  1. The Brief Resilience Scale

    Time frame: 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

  2. Self-Compassion Scale

    Time frame: 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

  3. Relationship Quality

    Time frame: 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

  4. Depression

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Caring Relationships Expression Study (CARES)

Acronym: CARES

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 28, 2022
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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