SOlution Focused brief therapy In post-stroke Aphasia (SOFIA Trial): protocol for a feasibility randomised controlled trial

Abstract

Background: Around a quarter of people post stroke will experience aphasia, a language disability. Having aphasia places someone at risk of becoming depressed and isolated. There is limited evidence for effective interventions to enhance psychological well-being for this client group. A potential intervention is Solution Focused Brief Therapy (SFBT), which supports a person to build meaningful, achievable change through focusing on a person’s skills and resources rather than their deficits. The SOFIA Trial aims to explore the acceptability of SFBT to people with varying presentations of aphasia, including severe aphasia, and to assess the feasibility of conducting a future definitive trial investigating clinical and cost effectiveness. Methods: The trial is a single-blind, randomised, wait-list controlled feasibility trial with nested qualitative research and pilot economic evaluation comparing SFBT plus usual care to usual care alone. The study will recruit 32 participants with aphasia who are ≥6 months post stroke. All participants will be assessed on psychosocial outcome measures at baseline, three, and six months post randomisation by assessors blinded to treatment allocation. Participants will be randomly assigned to intervention group (start intervention immediately post randomisation) or wait-list group (start intervention six months post randomisation). Wait-list group will additionally be assessed nine months post randomisation. The intervention consists of up to six SFBT sessions delivered over three months by speech and language therapists. Participants and therapists will also take part in in-depth interviews exploring their experiences of the study. The pilot economic evaluation will use the EQ-5D-5L measure and an adapted Client Service Receipt Inventory. People with aphasia have been involved in designing and monitoring the trial. Discussion: Given the high levels of depression and isolation, there is a need to investigate effective interventions that enhance the psychological wellbeing of people with aphasia. Trial registration: ClinicalTrials.gov NCT03245060 10/08/2017.