Background: Difficulties in learning and memory are among the most persistent and frequently reported cognitive symptoms in individuals with multiple sclerosis (MS).
Objective: To examine the efficacy of the self-generation learning program ( self-GEN trial) that consist of behavioral intervention sessions, teaching self-generation technique while using metacognitive strategies to improve learning and memory abilities in persons with MS. Additionally, the treatment aimed to address generalization of the treatment to activities of daily living.
Methods: This double-blind, placebo-controlled, randomized clinical trial included 35 participants with clinically definite MS, 19 in the treatment group and 16 in the placebo control group. Participants completed a baseline neuropsychological assessment, including questionnaires assessing everyday memory and a repeat assessment immediately post-treatment.
Results: The treatment group showed significantly improved learning and memory, self-regulation, and metacognition relative to the placebo post-treatment. Similar results were noted on measures of depression, functional status, and quality of life (QOL).
Conclusion: This study provides initial Class I evidence that the self-GEN behavioral intervention improves memory, self-regulation, functional status, affective symptomatology, and QOL in patients with MS.
Trial registration: ClinicalTrials.gov NCT02032589.
Keywords: Cognition; activities of daily living; memory; multiple sclerosis; randomized clinical trial; transfer.