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Abstract

Objectives: the SOlution Focused brief therapy In post-stroke Aphasia (SOFIA) 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; nested qualitative research.

Setting: participants identified via two community NHS Speech and Language Therapy London services and through community routes (e.g. voluntary-sector stroke groups).

Participants: people with aphasia at least six months post stroke.

Intervention: Solution Focused Brief Therapy, a psychological intervention, adapted to be linguistically accessible. Participants offered up to six sessions over three months, either immediately post randomisation or after a delay of six months.

Outcome measures: primary endpoints related to feasibility and acceptability. Clinical outcomes were collected at baseline, three- and six-months post randomisation, and at nine months (wait-list group only). The candidate primary outcome measure was the Warwick Edinburgh Mental Wellbeing Scale. Participants and therapists also took part in in-depth interviews.

Results: Thirty-two participants were recruited, including 44% 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 received ≥2 therapy sessions (90.6% received 6/6 sessions). Feasibility endpoints: recruitment target was reached within the pre-specified 13-month recruitment window; 82.1% of eligible participants consented; 96.9% were followed up at six months; missing data <0.01%. All five pre-specified 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 RCT of the intervention would be feasible.

Trial registration: ClinicalTrials.gov NCT03245060.

Publication Type:	Article
Additional Information:	© 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. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Publisher Keywords:	aphasia; SOFIA Trial; solution focused brief therapy; wellbeing
Subjects:	P Language and Literature > P Philology. Linguistics R Medicine > RT Nursing
Departments:	School of Health & Psychological Sciences > Healthcare Services Research & Management School of Health & Psychological Sciences > Language & Communication Science School of Health & Psychological Sciences > Nursing

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