Strengthening older adults remembering (SOARing): Research protocol for a multi-site randomized clinical trial examining the efficacy of the Kessler Foundation modified story memory technique (KF-mSMT®) in mild cognitive impairment (MCI)

Background: Long-term memory dysfunction is the hallmark feature of amnestic mild cognitive impairment (aMCI) resulting in substantial negative impact on everyday functioning and quality of life. The Kessler Foundation modified Story Memory Technique (KF-mSMT®) is a 10-session memory rehabilitation protocol in which participants are taught to utilize imagery and context to facilitate learning. This paper describes the protocol for a double blind, placebo controlled, randomized clinical trial (RCT) examining the efficacy of the KF-mSMT® in persons who meet criteria for aMCI. Methods: Participants will undergo baseline assessments consisting of neuropsychological testing, neuroimaging, self-report questionnaires, and a blood draw for measuring plasma biomarkers. Participants will then be randomized to one of two conditions using concealed allocation: KF-mSMT® or an active placebo control condition consisting of memory exercises. Participants will be blinded to condition. Within 2 weeks of completing the intervention, participants will complete the same measures as at baseline administered by treatment-blinded assessors. The primary study outcome is new learning and memory measured by neuropsychological assessment (Open Trial Selective Reminding Test). Secondary outcomes include other measures of learning and memory (i.e. Repeatable Battery for the Assessment of Neuropsychological Status story), visuospatial memory (Brief Visuospatial Memory Test-Revised)) as well as everyday memory (Ecological Memory Simulations, Object Location Touchscreen Test), neuroimaging and plasma biomarkers. Conclusion: If successful, this trial will provide Class I evidence supporting the application of the KF-mSMT® for treating MCI-related learning and memory decline in older adults.