TY - JOUR
T1 - Solution Focused brief therapy In post-stroke Aphasia (SOFIA): feasibility and acceptability results of a feasibility randomised wait-list controlled trial
AU - Northcott, Sarah
AU - Thomas, Shirley
AU - James, Kirsty
AU - Simpson, Alan
AU - Hirani, Shashivadan
AU - Barnard, Rachel
AU - Hilari, Katerina
N1 - Publisher Copyright:
© 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.
Copyright:
This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine
PY - 2021/8/19
Y1 - 2021/8/19
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85114660216&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-050308
DO - 10.1136/bmjopen-2021-050308
M3 - Article
SN - 2044-6055
VL - 11
SP - e050308
JO - BMJ Open
JF - BMJ Open
IS - 8
ER -