中风患者照顾者的生物心理社会干预（BISC）：可行性随机对照试验（RCT）方案

Biopsychosocial Intervention for Stroke Carers (BISC): protocol for a feasibility randomised controlled trial (RCT).

作者信息

Walker Marion F, Thomas Shirley A, Whitehead Phillip J, Condon Laura, Fisher Rebecca J, Kontou Eirini, Benford Penny, Cobley Christine

机构信息

Division of Rehabilitation and Ageing, University of Nottingham, The Medical School, Queen's Medical Centre, Nottingham, UK.

Department of Clinical Psychology, Derbyshire Healthcare NHS Foundation Trust, Derby, UK.

出版信息

BMJ Open. 2017 Oct 22;7(10):e018309. doi: 10.1136/bmjopen-2017-018309.

DOI:10.1136/bmjopen-2017-018309

PMID:29061630

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5665302/

Abstract

INTRODUCTION

Reducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT).

METHODS AND ANALYSIS

Feasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life.

ETHICS AND DISSEMINATION

Favourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences.

TRIAL REGISTRATION NUMBER

ISRCTN15643456; Pre-results.

摘要

引言

缩短中风幸存者的住院时间往往会使护理责任向非正式护理人员转移。许多护理人员在适应护理过程中感到压力巨大、复杂且要求苛刻，这可能对其身心健康和幸福感产生不利影响。国家政策指南建议考虑并满足护理人员的需求；尽管如此，很少有干预措施得到开发和实证评估。我们与中风幸存者的护理人员合作开发了一种生物心理社会干预措施。我们的目的是确定该干预措施能否在小组环境中实施，并通过随机对照试验（RCT）进行评估。

方法与分析

可行性随机对照试验和嵌套定性访谈研究。我们的目标是在中风发作后1年内招募多达40名中风护理人员。护理人员被随机分为接受常规护理或常规护理加生物心理社会干预。每个干预组将由五名中风护理人员组成。干预措施将侧重于：心理教育、对中风的心理调适、减少不必要的消极思想和情绪的策略以及解决问题的策略。主要结果是进行随机对照试验的可行性。护理人员在6个月时的结果包括：焦虑和抑郁、生活质量和护理负担。还在基线和6个月时从中风幸存者那里收集数据，包括：残疾程度、焦虑和抑郁以及生活质量。

伦理与传播

东米德兰兹 - 诺丁汉2研究伦理委员会（14/EMI/1264）给出了有利的伦理意见。本研究将确定生物心理社会干预措施以小组形式提供给中风护理人员是否可行且可接受。它还将确定在随机对照试验中评估生物心理社会干预措施的效果是否可行。我们将通过同行评审的出版物以及在国内和国际会议上的报告来传播我们的研究结果。