Video-Delivered Emotion-Focused Mindfulness Therapy for late- life anxiety: Study Protocol for a Feasibility Randomized Controlled Trial During COVID-19

Abstract Background: The worldwide prevalence of anxiety in older adults is estimated at between 6% and 10%. In Canada, adults 65 and older experience anxiety at a rate of 6.4%, affecting more than 300,000 people. Anxiety in older adults has been linked to difficulties retaining new information and engaging in instrumental daily activities of living. Due to COVID-19 restrictions, novel methods of delivering therapy programs remotely are needed, however data is limited. There is some evidence that older adults prefer non-pharmacological approaches for anxiety that can be delivered in the community. Emotion-Focused Mindfulness Therapy (EFMT) is a mindfulness-based intervention that emphasizes meditation and observing thoughts and emotions as they arise. This emphasis has been demonstrated to reduce symptoms of anxiety in general populations. This study aims to evaluate the feasibility of EFMT with older adults.Methods: This pilot feasibility randomized controlled trial will use a wait list control trial design. Due to COVID-19 restrictions, we will use telehealth delivery via Zoom rather than in-person delivery. The first 48 people to meet the eligibility criteria will be randomly allocated to either receive EFMT immediately, or in approximately eight weeks time from enrollment (1:1 allocation ratio). Data will be collected at baseline, eight weeks following baseline, and sixteen weeks following baseline. The primary outcomes will determine the feasibility of the intervention based on recruitment, enrolment, retention and adherence to all components of the intervention. The secondary outcome will be changes to anxiety over time.Discussion: The results of this trial will determine the feasibility and potential effectiveness of video-delivered EFMT for late-life anxiety compared to no treatment. If the results are promising, a larger randomized controlled trial may be conducted.Trial registration: ClinicalTrials.gov: NCT04415528. Registered on June 4, 2020Protocol version: Protocol version 2, January 2, 2021