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Stress Reduction Techniques for Caregiver Stress (CARES Trial)

Phase 1 & 2

Waitlist Available

Led By Linda K Larkey, PhD

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 8 weeks at end of intervention

Awards & highlights

CARES Trial Summary

This trial will compare two interventions to help reduce stress in family caregivers of Alzheimer's and Dementia patients. It will measure feasibility, burden, stress, resilience, anxiety, self-compassion, and relationship quality.

Who is the study for?

This trial is for primary, unpaid family caregivers who have been caring for a relative with Alzheimer's or related dementias for over 6 months. Participants must own a smartphone with a data plan and experience caregiver burden. Those with pacemakers, ICDs, or conditions/medications affecting heart rate variability cannot join.Check my eligibility

What is being tested?

The study tests if heart rate variability biofeedback can help reduce stress and improve well-being in caregivers compared to just listening to music. Over 8 weeks, it will look at changes in caregiver burden, anxiety, resilience, self-compassion, and relationship quality.See study design

What are the potential side effects?

There are minimal side effects expected from this trial as the interventions involve non-invasive techniques like biofeedback and music listening which are generally considered safe.

CARES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 8 weeks at end of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 8 weeks at end of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 8 weeks at end of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Caregiver Burden

Perceived Stress Scale-10 (PSS-10)

Secondary outcome measures

Depression

Relationship Quality

Self-Compassion Scale

+1 more

CARES Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Heart Rate Variability BiofeedbackActive Control1 Intervention

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.

Group II: Music Listening ControlPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Arizona State UniversityLead Sponsor

283 Previous Clinical Trials

109,476 Total Patients Enrolled

7 Trials studying Anxiety

4,762 Patients Enrolled for Anxiety

Linda K Larkey, PhDPrincipal InvestigatorArizona State University

1 Previous Clinical Trials

21 Total Patients Enrolled

Media Library

Heart Rate Variability Biofeedback Clinical Trial Eligibility Overview. Trial Name: NCT05627687 — Phase 1 & 2

Anxiety Research Study Groups: Heart Rate Variability Biofeedback, Music Listening Control

Anxiety Clinical Trial 2023: Heart Rate Variability Biofeedback Highlights & Side Effects. Trial Name: NCT05627687 — Phase 1 & 2

Heart Rate Variability Biofeedback 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627687 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the anticipated outcome of this experiment?

"This trial will measure its progress over an 8-week period, with the primary metric being the Perceived Stress Scale-10 (PSS-10). Secondary outcomes include scores from the Self Compassion Scale (ranging 12 to 60, higher is better), Relationship Quality survey (5 to 20, high score indicates good relationship quality) and PHQ4 Depression scores (0 to 12, where a low score reflects improved mood.)"

Answered by AI

Can those looking for clinical trial participation currently sign up?

"Affirmative. According to the data on clinicaltrials.gov, this medical trial was initially published on December 13th 2021 and has been amended as recently as November 16th 2022. 30 patients are being sought from a single site for participation in the study."

Answered by AI

What is the total participant capacity for this research endeavor?

"Affirmative. According to information retrieved from clinicaltrials.gov, this medical experiment is actively attempting to enrol participants and was first published on December 13th 2021. Last updated on November 16th 2022, the research requires 30 people to be recruited at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Caring Relationships Expression Study

Linda Larkey 2021. "Caring Relationships Expression Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05627687.