Centre for Language and Communication Science, City, University of London, London, UK
Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
BMJ Open. 2021 Aug 18;11(8):e050308. doi: 10.1136/bmjopen-2021-050308.
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.
Two-group randomised controlled feasibility trial with wait-list design, blinded outcome assessors and nested qualitative research.
Participants identified via two community NHS Speech and Language Therapy London services and through community routes (eg, voluntary-sector stroke groups).
People with aphasia at least 6 months post stroke.
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.
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.
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.
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.
NCT03245060.
卒中后失语症的焦点解决式短期心理疗法可行性试验有四个主要目的：（1）评估干预措施对失语症患者（包括严重失语症患者）的可接受性；（2）评估招募和保留的可行性；（3）评估研究程序和结果测量的可接受性；（4）评估言语治疗师实施干预措施的可行性。
两组随机对照可行性试验，采用等待名单设计，对结果评估者设盲，并进行嵌套式定性研究。
通过两个社区内的英国国家医疗服务体系言语治疗服务和社区途径（例如，志愿性中风群体）确定参与者。
卒中后至少 6 个月的失语症患者。
焦点解决式短期心理疗法，一种心理干预措施，经调整以使其更具语言可及性。参与者在随机分组后即刻或延迟 6 个月后，最多接受 6 次治疗，每次治疗持续 3 个月。
主要结局指标与可行性和可接受性相关。临床结局在随机分组后 3 个月和 6 个月以及 9 个月（仅等待名单组）时收集。候选的主要结局指标为华威-爱丁堡心理健康量表。参与者和治疗师还参加了深入访谈。
共招募了 32 名参与者，其中 43.8%的参与者有严重失语症。可接受性结局指标：治疗被参与者（30 次访谈）和治疗师（3 次访谈）均认为有价值和可接受；93.8%的参与者完成了≥2 次治疗（90.6%完成了 6/6 次治疗）。可行性结局指标：在规定的 13 个月的招募窗口期内达到了招募目标；82.1%的合格参与者同意参与；96.9%的参与者在 6 个月时得到了随访；缺失数据<0.01%。所有五个预先规定的可行性进展标准均得到满足。
高保留率和依从率，以及定性数据表明，研究设计是可行的，治疗方法是可以接受的，即使是严重失语症患者也可以接受。这些结果表明，该干预措施的确定性随机对照试验是可行的。
NCT03245060。
