Thomas Shirley A, Coates Elizabeth, das Nair Roshan, Lincoln Nadina B, Cooper Cindy, Palmer Rebecca, Walters Stephen J, Latimer Nicholas R, England Timothy J, Mandefield Laura, Chater Timothy, Callaghan Patrick, Drummond Avril E R
Division of Rehabilitation and Ageing, School of Medicine, B Floor Medical School, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH UK.
Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
Pilot Feasibility Stud. 2016 Aug 10;2:45. doi: 10.1186/s40814-016-0072-0. eCollection 2016.
There is currently insufficient evidence for the clinical and cost-effectiveness of psychological therapies for treating post-stroke depression.
METHODS/DESIGN: BEADS is a parallel group feasibility multicentre randomised controlled trial with nested qualitative research and economic evaluation. The aim is to evaluate the feasibility of undertaking a full trial comparing behavioural activation (BA) to usual stroke care for 4 months for patients with post-stroke depression. We aim to recruit 72 patients with post-stroke depression over 12 months at three centres, with patients identified from the National Health Service (NHS) community and acute services and from the voluntary sector. They will be randomly allocated to receive behavioural activation in addition to usual care or usual care alone. Outcomes will be measured at 6 months after randomisation for both participants and their carers, to determine their effectiveness. The primary clinical outcome measure for the full trial will be the Patient Health Questionnaire-9 (PHQ-9). Rates of consent, recruitment and follow-up by centre and randomised group will be reported. The acceptability of the intervention to patients, their carers and therapists will also be assessed using qualitative interviews. The economic evaluation will be undertaken from the National Health Service and personal social service perspective, with a supplementary analysis from the societal perspective. A value of information analysis will be completed to identify the areas in which future research will be most valuable.
The feasibility outcomes from this trial will provide the data needed to inform the design of a definitive multicentre randomised controlled trial evaluating the clinical and cost-effectiveness of behavioural activation for treating post-stroke depression.
Current controlled trials ISRCTN12715175.
目前，关于心理治疗对中风后抑郁症的临床疗效和成本效益，证据尚不充分。
方法/设计：BEADS是一项平行组可行性多中心随机对照试验，包含嵌套式定性研究和经济评估。目的是评估开展一项全面试验的可行性，该试验将比较行为激活疗法（BA）与常规中风护理对中风后抑郁症患者进行为期4个月治疗的效果。我们的目标是在12个月内，于三个中心招募72名中风后抑郁症患者，这些患者来自国民健康服务体系（NHS）的社区及急症服务部门以及志愿部门。他们将被随机分配，一组除接受常规护理外还接受行为激活疗法，另一组仅接受常规护理。在随机分组6个月后，将对参与者及其护理人员进行结果测量，以确定其有效性。全面试验的主要临床结果测量指标将是患者健康问卷-9（PHQ-9）。将报告各中心及随机分组的同意率、招募率和随访率。还将通过定性访谈评估患者、其护理人员和治疗师对干预措施的可接受性。经济评估将从国民健康服务体系和个人社会服务的角度进行，并从社会角度进行补充分析。将完成信息价值分析，以确定未来研究最具价值的领域。
该试验的可行性结果将提供所需数据，为设计一项确定性多中心随机对照试验提供信息，该试验将评估行为激活疗法治疗中风后抑郁症的临床疗效和成本效益。
当前受控试验ISRCTN12715175。
