MELLO: Study Protocol: A Feasibility Randomised Controlled Trial Of Listening Based Leisure Activities Following Ischemic Stroke

Abstract

Background and aims: Stroke is the leading cause of disability in older adults. Early post-stroke interventions often focus on physical recovery. Less attention is paid to mood and cognition enhancing interventions that have the potential to improve well-being without the adverse side effects associated with pharmacological interventions. Daily music listening is an accessible and a low cost activity that has been suggested to have a beneficial effect on cognition and mood post stroke. The mechanism of this effect, or if it is reliable, however is not clear. It is speculated that music listening may enhance control of attention in a similar way to mindfulness interventions, that have been demonstrated to be beneficial in the treatment of mood disorders. This study aims to investigate the feasibility and acceptability of a novel intervention combining music listening with brief mindfulness training, within a randomised controlled trial (RCT) context, early post stroke. Method: This is a three-arm, parallel group, single-blind pilot randomised controlled trial (RCT). Individuals with ischemic stroke undergo assessment of mood and cognition (attention and memory) within four weeks post-stroke prior to being randomised to receive an 8-week music listening, mindful music listening, or audiobook listening intervention. Follow-up assessments of mood and cognition are carried out at 3-months and 6-months post-stroke. In addition, a qualitative interview exploring participants’ experience will be completed post intervention. Conclusions: If the mindful music listening intervention is found to be feasible and acceptable, a full scale RCT to investigate its efficacy would be warranted