Caregiver BurdenPhase 1/2CARESNCT05627687
Caring Relationships Expression Study
A Phase 1/2 study testing Heart Rate Variability Biofeedback in people with Caregiver Burden and Anxiety, run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Anxiety, Stress
- What is being tested?
- Heart Rate Variability Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 1 Jul 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In primary/unpaid FCG role > 6 months
- Caring for mild-to-severe ADRD patient
- 4 caregiver burden score Own/operate smartphone w data plan
Who cannot join
- Pacemakers or implanted cardioconverter defibrillator (ICD), or conditions/meds that interfere with HRV measurement/feedback
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona State University Downtown Campus
Phoenix, Arizona, 85004
About this study
Official title: Caring Relationships Expression Study (CARES)
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.
Read the 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.
- Conditions
- Caregiver Burden, Anxiety, Stress
- Being tested
- Heart Rate Variability Biofeedback, Music Listening Control
- Keywords
- Heart Rate Variability, Biofeedback, Alzheimer's disease, Dementia
- Medical subject headings
- Caregiver Burden, Anxiety Disorders, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Variability BiofeedbackBehavioural
Also called Heart Focused breathing
Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week
Music Listening ControlBehavioural
Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week
| Study group | Role | What they receive |
|---|---|---|
| Music Listening Control | Placebo comparator | 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. Receives: Behavioral: Music Listening Control |
| Heart Rate Variability Biofeedback | Active comparator | 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. Receives: Behavioral: Heart Rate Variability Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale-10 (PSS-10)
10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress
Measured: 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
Measured: Change from baseline to 8 weeks at end of intervention
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to 8 weeks at end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start13 Dec 2021
- Primary completion28 Feb 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Larkey, Arizona State University
- Investigators
- Linda K Larkey, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627687
- Sponsor's protocol ID
- 00014913
- Acronym
- CARES
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring Relationships Expression Study (CARES)
- ClinicalTrials.gov ID
- NCT05627687
- Acronym / sponsor ID
- CARES / 00014913
- Conditions
- Caregiver Burden, Anxiety, Stress
- Keywords
- Heart Rate Variability, Biofeedback, Alzheimer's disease, Dementia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music Listening Control | Placebo comparator | Behavioral: Music Listening ControlMusic 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. |
| Heart Rate Variability Biofeedback | Active comparator | Behavioral: Heart Rate Variability BiofeedbackParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In primary/unpaid FCG role > 6 months
- Caring for mild-to-severe ADRD patient
Key exclusion criteria (1 listed)
- Pacemakers or implanted cardioconverter defibrillator (ICD), or conditions/meds that interfere with HRV measurement/feedback
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate Variability BiofeedbackAlso: Heart Focused breathingPractice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week | Behavioural | Heart Rate Variability Biofeedback |
| Music Listening ControlListening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week | Behavioural | Music Listening Control |
Primary outcome
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
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
4 secondary outcomes
The Brief Resilience Scale
Time frame: Change from baseline to 8 weeks at end of intervention
Self-Compassion Scale
Time frame: Change from baseline to 8 weeks at end of intervention
Relationship Quality
Time frame: Change from baseline to 8 weeks at end of intervention
Depression
Time frame: Change from baseline to 8 weeks at end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda K Larkey, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Heart Rate Variability Biofeedback in people with Caregiver Burden and Anxiety, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale-10 (PSS-10) (time frame: Change from baseline to 8 weeks at end of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.