Status:
RECRUITING
Cereset Research for Caregivers
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Memory Counseling Program general fund
Heidi Munger-Clary, MD
Conditions:
Caregivers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Caregivers experience high levels of prolonged stress that can lead to chronic problems with health, including increased risk of cardiovascular disease that is linked to autonomic dysregulation. Heart...
Detailed Description
Phase I: Intervention only pre-piloting: up to 5 adults; mirroring Phase II characteristics described below Phase II: 20 caregivers experiencing symptoms of stress, anxiety or insomnia. Primary aims ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Participants must provide caregiving at least 10 hours per week. This includes all types of caregiving
- participants must be willing to provide informed consent
- participants must be able to comply with basic instructions
- participants must be able to sit comfortably for up to 90 minutes, and attend up to three 60-minute intervention sessions each week during the 4-week intervention period
- participants must self report experiencing symptoms of stress, anxiety, or insomnia and meet threshold scores on one or more self-report inventories of these symptoms (Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale)
- Exclusion criteria:
- participants providing less than 10 hours a week of care to a person
- participants who are unable or unwilling to attend intervention sessions during the planned study period
- participants who are unable or unwilling to provide consent
- participants who are not exhibiting symptoms of stress, anxiety or insomnia
- participants with hearing impairment severe enough that they cannot perceive tones through ear buds
- participants with known seizure disorder, or suicidal thoughts within the last 3 months
- participants who respond positively to a question about risk for suicide within the last 3 months will be excluded and receive a behavioral health resource list
- participants weighing more than 400 pounds (the weight limit of the chair used during intervention)
- participants currently enrolled in another intervention study
- prior use (past 3 years) of the technology being tested
- prior use of neuromodulation, neurostimulation, deep brain stimulation, neurofeedback, biofeedback, alpha stim, Eye Movement Desensitization and Reprocessing (EMDR),or electroconvulsive therapy within the last month
- Pace makers and beta blockers that affect the assessment of heart rate variability will also be exclusionary
- participants taking Medications that may affect the assessment of heart rate variability (beta blockers.
Exclusion
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05209438
Start Date
June 16 2022
End Date
July 1 2026
Last Update
July 15 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157