Caring Relationships Expression Study

Anxiety Clinical Trial

— CARES  

Official title:

Caring Relationships Expression Study (CARES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05627687
• Other study ID #: 00014913
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 13, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2024
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 burden, stress, resilience, anxiety, self-compassion, and relationship quality over the course of 8-weeks.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Caregiver Burden
• Stress

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Arizona State University Downtown Campus	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress Scale-10 (PSS-10)	10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress	Change from baseline to 8 weeks at end of intervention
Primary	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	Change from baseline to 8 weeks at end of intervention
Secondary	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	Change from baseline to 8 weeks at end of intervention
Secondary	Self-Compassion Scale	Self-Compassion Scale contains 12 items scoring 1-5, total score range, 12-60 with higher scores indicating higher self-compassion	Change from baseline to 8 weeks at end of intervention
Secondary	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	Change from baseline to 8 weeks at end of intervention
Secondary	Depression	Patient Health Questionnaire-4 (PHQ4) using 4 items scoring 0-3, total range 0-12 with higher scores indicating poor mood	Change from baseline to 8 weeks at end of intervention