Protocol for the Reducing Fear-Avoidance of Memory Loss (REFRAME) Study: A randomized controlled trial investigating the feasibility of a low-intensity psychological intervention for fear of memory loss and quality of life in older adults. (Preprint)
BACKGROUND Dementia is the most feared disease associated with aging. These fears can have harmful consequences even in the absence of cognitive decline. Fear of dementia is associated with poorer health outcomes, reduced psychological wellbeing and increased memory failures in older adults. OBJECTIVE We will conduct a randomized controlled trial to determine the feasibility of a tailored, web-based mindfulness program to reduce fear of memory loss and increase quality of life in older adults experiencing heightened fear. METHODS One group will receive psychoeducation along with brief mindfulness training, which facilitates non-judgmental awareness to manage psychological distress. A second group will receive psychoeducation, mindfulness training and additional modules targeting maladaptive behavioral avoidance (i.e., social and cognitive withdrawal). RESULTS Our recent etiological model posits that maladaptive behavioral avoidance strategies critically underlie psycho-social dysfunction associated with fear of memory loss. Thus, we predict better outcomes in the second group, including fear of memory loss (primary outcome), fear of Alzheimer’s disease, quality of life, anxiety and subjective memory failures (secondary outcomes). Outcome measures will be applied at five time points (pre-, baseline, interim-, and post-intervention as well as at 3-month follow up). CONCLUSIONS Data will be analyzed using mixed models, correlations and t-tests. This study was approved by the IRB at Northwestern University (USA) and data collection will take place between May and August 2021. CLINICALTRIAL Trial Registration Number: NCT04821960