Solution Focused Brief Therapy in Post-Stroke Aphasia (SOFIA): feasibility and acceptability results of a feasibility randomised wait-list controlled trial

Sarah Northcott, Shirley Thomas, Kirsty James, Alan Simpson, Shashivadan Hirani, Rachel Barnard, Katerina Hilari, Sarah Northcott, Shirley Thomas, Kirsty James, Alan Simpson, Shashivadan Hirani, Rachel Barnard, Katerina Hilari

Abstract

Objectives: The Solution Focused Brief Therapy in Post-Stroke Aphasia feasibility trial had four primary aims: to assess (1) acceptability of the intervention to people with aphasia, including severe aphasia, (2) feasibility of recruitment and retention, (3) acceptability of research procedures and outcome measures, and (4) feasibility of delivering the intervention by speech and language therapists.

Design: Two-group randomised controlled feasibility trial with wait-list design, blinded outcome assessors and nested qualitative research.

Setting: Participants identified via two community NHS Speech and Language Therapy London services and through community routes (eg, voluntary-sector stroke groups).

Participants: People with aphasia at least 6 months post stroke.

Intervention: Solution-focused brief therapy, a psychological intervention, adapted to be linguistically accessible. Participants offered up to six sessions over 3 months, either immediately postrandomisation or after a delay of 6 months.

Outcome measures: Primary endpoints related to feasibility and acceptability. Clinical outcomes were collected at baseline, 3 and 6 months postrandomisation, and at 9 months (wait-list group only). The candidate primary outcome measure was the Warwick-Edinburgh Mental Well-being Scale. Participants and therapists also took part in in-depth interviews.

Results: Thirty-two participants were recruited, including 43.8% with severe aphasia. Acceptability endpoints: therapy was perceived as valuable and acceptable by both participants (n=30 interviews) and therapists (n=3 interviews); 93.8% of participants had ≥2 therapy sessions (90.6% had 6/6 sessions). Feasibility endpoints: recruitment target was reached within the prespecified 13-month recruitment window; 82.1% of eligible participants consented; 96.9% were followed up at 6 months; missing data <0.01%. All five prespecified feasibility progression criteria were met.

Conclusion: The high retention and adherence rates, alongside the qualitative data, suggest the study design was feasible and therapy approach acceptable even to people with severe aphasia. These results indicate a definitive randomised controlled trial of the intervention would be feasible.

Trial registration number: NCT03245060.

Keywords: mental health; rehabilitation medicine; stroke medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Solution Focused Brief Therapy in Post-Stroke Aphasia trial Consolidated Standards of Reporting Trials diagram. SLT, speech and language therapist.
Figure 2
Figure 2
Standardised treatment effects at 3 and 6 months. CPIB, Communicative Participation Item Bank; DISCs, Depression Intensity Scale Circles; GHQ-12, General Health Questionnaire-12; WEMWBS, Warwick Edinburgh Mental Well-being Scale.

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