Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 23, 2023
Date Accepted: Jul 17, 2023
Mindfulness-Based App to Reduce Stress in Caregivers of Persons with Alzheimer’s Disease and Related Dementias: Protocol for a Single-Blind, Feasibility, Proof of Concept RCT
ABSTRACT
Background:
Informal caregivers (i.e., individuals that provide assistance to a known person with health or functional needs, often unpaid) experience high levels of stress. Caregiver stress is associated with negative outcomes for both caregivers and care-recipients. Mindfulness-based interventions (MBIs) show promise for improving stress, emotional distress, and sleep disturbance in caregivers of persons with Alzheimer’s disease and related dementias (ADRD). Commercially available mobile mindfulness apps can deliver MBIs to caregivers of persons with ADRD in a feasible and cost-effective manner.
Objective:
We are conducting a single-blind feasibility, proof of concept randomized controlled trial (RCT; NIH stage 1B) comparing two free mobile applications: the active intervention Healthy Minds Program (HMP) with within app text tailored for addressing stress among caregivers of persons with ADRD, versus Wellness App (WA), a time- and dose- matched educational control also tailored for caregivers of persons with ADRD.
Methods:
We aim to recruit 80 geographically diverse stressed caregivers of persons with ADRD. Interested caregivers use a link or QR code on a recruitment flyer to complete an online eligibility screener. Research assistants conduct enrollment phone calls during which participants provide electronic informed consent. After participants complete baseline surveys, we randomize them to the mindfulness-based intervention (HMP) or educational control podcast app (WA) and instruct them to listen to prescribed content for ten minutes per day (70 minutes/week) for 12 weeks. Caregivers are blinded to intervention versus control. The study team checks adherence weekly and contacts participants to promote adherence, as needed. Participants complete self-report measures online at baseline, post-test, and follow-up; weekly process measures are also completed. Primary outcomes are a priori set feasibility benchmarks. Secondary outcomes are stress, emotional distress, sleep disturbance, caregiver burden, mindfulness, awareness, connection, insight, and purpose.
Results:
Recruitment started on February 20th 2023. We have enrolled 27 caregivers (14 HMP and 13 WA) as of June 2023.
Conclusions:
Through this trial, we aim to establish feasibility benchmarks of HMP and WA for a subsequent R01 efficacy trial (NIH stage II) testing HMP among stressed caregivers of persons with ADRD. If feasible and efficacious, HMP has the potential to be a cost-effective solution to reduce stress in caregivers of persons with ADRD, benefitting caregiver health and quality of care as well as patient care. Clinical Trial: ClinicalTrials.gov NCT05732038
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