School of Medicine, University of Nottingham, Nottingham, UK.
School of Health Sciences, University of Nottingham, Nottingham, UK.
Health Technol Assess. 2019 Sep;23(47):1-176. doi: 10.3310/hta23470.
BACKGROUND: There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression. OBJECTIVE: To evaluate the feasibility of undertaking a definitive trial to evaluate the clinical effectiveness and cost-effectiveness of behavioural activation (BA) compared with usual stroke care for treating post-stroke depression. DESIGN: Parallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation. SETTING: Acute and community stroke services in three sites in England. PARTICIPANTS: Community-dwelling adults 3 months to 5 years post stroke who are depressed, as determined by the Patient Health Questionnaire-9 (PHQ-9) or the Visual Analogue Mood Scales 'Sad' item. Exclusions: patients who are blind and/or deaf, have dementia, are unable to communicate in English, do not have mental capacity to consent, are receiving treatment for depression at the time of stroke onset or are currently receiving psychological intervention. RANDOMISATION AND BLINDING: Participants were randomised (1 : 1 ratio) to BA or usual stroke care. Randomisation was conducted using a computer-generated list with random permuted blocks of varying sizes, stratified by site. Participants and therapists were aware of the allocation, but outcome assessors were blind. INTERVENTIONS: The intervention arm received up to 15 sessions of BA over 4 months. BA aims to improve mood by increasing people's level of enjoyable or valued activities. The control arm received usual care only. MAIN OUTCOME MEASURES: Primary feasibility outcomes concerned feasibility of recruitment to the main trial, acceptability of research procedures and measures, appropriateness of baseline and outcome measures, retention of participants and potential value of conducting the definitive trial. Secondary feasibility outcomes concerned the delivery of the intervention. The primary clinical outcome 6 months post randomisation was the PHQ-9. Secondary clinical outcomes were Stroke Aphasic Depression Questionnaire - Hospital version, Nottingham Leisure Questionnaire, Nottingham Extended Activities of Daily Living, Carer Strain Index, EuroQol-5 Dimensions, five-level version and health-care resource use questionnaire. RESULTS: Forty-eight participants were recruited in 27 centre-months of recruitment, at a recruitment rate of 1.8 participants per centre per month. The 25 participants randomised to receive BA attended a mean of 8.5 therapy sessions [standard deviation (SD) 4.4 therapy sessions]; 23 participants were allocated to usual care. Outcome assessments were completed by 39 (81%) participants (BA, = 18; usual care, = 21). Mean PHQ-9 scores at 6-month follow-up were 10.1 points (SD 6.9 points) and 14.4 points (SD 5.1 points) in the BA and control groups, respectively, a difference of -3.8 (95% confidence interval -6.9 to -0.6) after adjusting for baseline PHQ-9 score and centre, representing a reduction in depression in the BA arm. Therapy was delivered as intended. BA was acceptable to participants, carers and therapists. Value-of-information analysis indicates that the benefits of conducting a definitive trial would be likely to outweigh the costs. It is estimated that a sample size of between 580 and 623 participants would be needed for a definitive trial. LIMITATIONS: Target recruitment was not achieved, although we identified methods to improve recruitment. CONCLUSIONS: The Behavioural Activation Therapy for Depression after Stroke trial was feasible with regard to the majority of outcomes. The outstanding issue is whether or not a sufficient number of participants could be recruited within a reasonable time frame for a definitive trial. Future work is required to identify whether or not there are sufficient sites that are able to deliver the services required for a definitive trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12715175. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 47. See the NIHR Journals Library website for further project information.
背景:目前,针对中风后抑郁症的心理疗法的临床效果和成本效益尚无充分证据。
目的:评估开展一项确定性试验以评估行为激活(BA)与常规卒中护理治疗中风后抑郁症的临床效果和成本效益的可行性。
设计:平行组、可行性、多中心、随机对照试验,嵌套定性研究和健康经济评估。
地点:英格兰三个地点的急性和社区卒中服务。
参与者:社区居住的中风后 3 个月至 5 年且患有抑郁症的成年人,通过患者健康问卷-9(PHQ-9)或视觉模拟情绪量表“悲伤”项来确定。排除标准:盲人和/或聋人、痴呆症、无法用英语交流、无同意能力、中风发作时正在接受抑郁症治疗或目前正在接受心理干预的患者。
随机分组和设盲:参与者按 1:1 比例随机分配至 BA 或常规卒中护理。使用具有不同大小随机排列块的计算机生成列表进行随机分组,按地点分层。参与者和治疗师了解分配情况,但结果评估师是盲的。
干预:干预组在 4 个月内接受最多 15 次 BA。BA 旨在通过增加人们享受或有价值的活动水平来改善情绪。对照组仅接受常规护理。
主要结果测量:主要可行性结果涉及主要试验的招募可行性、研究程序和措施的可接受性、基线和结局测量的适当性、参与者的保留率以及进行确定性试验的潜在价值。次要可行性结果涉及干预措施的实施。随机分组后 6 个月的主要临床结局是 PHQ-9。次要临床结局包括中风失语性抑郁症问卷-医院版、诺丁汉休闲问卷、诺丁汉扩展日常生活活动、照顾者压力指数、EuroQol-5 维度,五级版和卫生保健资源使用问卷。
结果:在 27 个月的招募期间,招募了 48 名参与者,每个中心每月招募 1.8 名参与者。25 名随机接受 BA 的参与者接受了平均 8.5 次治疗(标准偏差 4.4 次治疗);23 名参与者接受了常规护理。39 名(81%)参与者完成了结局评估(BA,n=18;常规护理,n=21)。BA 和对照组在 6 个月随访时的平均 PHQ-9 评分分别为 10.1 分(标准差 6.9 分)和 14.4 分(标准差 5.1 分),调整基线 PHQ-9 评分和中心后,BA 组降低了-3.8(95%置信区间-6.9 至-0.6),表明 BA 臂中的抑郁症状有所减轻。治疗按计划进行。BA 得到了参与者、照顾者和治疗师的接受。价值信息分析表明,进行确定性试验的好处可能超过成本。估计需要 580 至 623 名参与者进行确定性试验。
局限性:虽然我们确定了提高招募率的方法,但未达到目标招募人数。
结论:行为激活治疗中风后抑郁症试验在大多数结局方面是可行的。尚未解决的问题是,在合理的时间框架内是否能够招募足够数量的参与者进行确定性试验。未来的工作需要确定是否有足够的能够提供确定性试验所需服务的站点。
试验注册:当前对照试验 ISRCTN81636232。
资金:该项目由英国国立卫生研究院健康技术评估计划资助,将在 ; Vol. 23, No. 47 中全文发表。欲了解更多项目信息,请访问英国国立卫生研究院期刊图书馆网站。
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