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Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2).
Trials ( IF 2.5 ) Pub Date : 2020-04-01 , DOI: 10.1186/s13063-020-4181-y
Mark Hayward 1, 2 , Clio Berry 1 , Ben Cameron 3 , Kate Arnold 2 , Katherine Berry 4 , Stephen Bremner 5 , Kate Cavanagh 1 , David Fowler 1 , Heather Gage 6 , Kathryn Greenwood 1 , Cassie Hazell 7 , Anna-Marie Jones 2 , Sam Robertson 2 , Clara Strauss 8
Affiliation  

BACKGROUND The National Institute for Health and Care Excellence (NICE) recommends that Cognitive Behaviour Therapy for psychosis (CBTp) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBTp. This is attributable, in part, to the resource-intensive nature of CBTp. One response to this problem has been the development of CBTp in brief formats that are targeted at a single symptom and the mechanisms that maintain distress. We have developed a brief form of CBTp for distressing voices and reported preliminary evidence for its effectiveness when delivered by highly trained therapists (clinical psychologists). This study will investigate the delivery of this intervention by a cost-effective workforce of assistant psychologists following a brief training and evaluate the acceptability and feasibility of conducting a future, definitive, randomised controlled trial (RCT). METHODS This is a feasibility study for a pragmatic, three-arm, parallel-group, superiority 1:1:1 RCT comparing a Guided self-help CBT intervention for voices and treatment as usual (GiVE) to Supportive Counselling and treatment as usual (SC) to treatment as usual alone (TAU), recruiting across two sites, with blinded post-treatment and follow-up assessments. A process evaluation will quantitatively and qualitatively explore stakeholder experience. DISCUSSION Expected outcomes will include an assessment of the feasibility of conducting a definitive RCT, and data to inform the calculation of its sample size. If evidence from a subsequent, fully powered RCT suggests that GiVE is clinically and cost-effective when delivered by briefly trained assistant psychologists, CBTp offered in these less resource-intensive forms has the potential to generate benefits for individual patients (reduced distress, enhanced recovery and enhanced quality of life), service-level patient benefit (increased access to evidence-based psychological therapies) and economic benefits to the NHS (in terms of the reduced use of mental health inpatient services). TRIAL REGISTRATION Current Controlled Trials, ISRCTN registration number: 16166070. Registered on 5 February 2019.

中文翻译:

精神病患者越来越多地使用CBT:一项可行的随机对照试验,评估简短的,有针对性的CB​​T对助理心理学家(GiVE2)发出的令人不快的声音。

背景技术美国国家卫生与医疗保健研究院(NICE)建议为所有患有精神病诊断的患者提供针对精神病的认知行为疗法(CBTp)。但是,只有英格兰和威尔士的少数精神病患者可以接受CBTp治疗。这部分归因于CBTp的资源密集型性质。解决此问题的一种方法就是以一种单一的症状和维持痛苦的机制开发了简短形式的CBTp。我们已经开发出一种简短的CBTp形式,可减轻声音困扰,并报告了由训练有素的治疗师(临床心理学家)提供的CBTp有效性的初步证据。这项研究将调查经过简短培训的,由具有成本效益的助理心理学家提供的干预措施,并评估进行未来的确定性随机对照试验(RCT)的可接受性和可行性。方法这是一项针对实用,三臂,平行小组,优势1:1:1 RCT的可行性研究,比较了引导性自助CBT干预措施(通常为声音和治疗(GiVE))与常规支持咨询和治疗( SC)照常治疗(TAU),在两个地点招募人员,并进行盲目的治疗后评估和随访评估。流程评估将定量和定性地探索利益相关者的经验。讨论预期结果将包括评估进行确定性RCT的可行性,和数据来告知其样本量的计算。如果随后进行的功能强大的RCT的证据表明,经过短暂训练的助理心理学家提供的GiVE在临床上具有成本效益,那么以这些资源较少的形式提供的CBTp可能为单个患者带来益处(减少痛苦,提高康复速度)以及提高生活质量),服务水平的患者利益(增加基于证据的心理疗法的获取)和对NHS的经济利益(就减少对心理健康住院服务的使用而言)。试用注册当前对照试验,ISRCTN注册号:16166070。于2019年2月5日注册。功能强大的RCT表明,GiVE由经过短暂培训的助理心理学家提供,具有临床和成本效益,以这些资源较少的形式提供的CBTp可能为单个患者带来益处(减少痛苦,提高康复和生活质量) ,服务级别的患者利益(增加了基于证据的心理疗法的获取)和NHS的经济利益(就减少了对心理健康住院服务的使用而言)。试用注册当前对照试验,ISRCTN注册号:16166070。于2019年2月5日注册。功能强大的RCT表明,GiVE由经过短暂培训的助理心理学家提供,具有临床和成本效益,以这些资源较少的形式提供的CBTp可能为单个患者带来益处(减少痛苦,提高康复和生活质量) ,服务级别的患者利益(增加了基于证据的心理疗法的获取)和NHS的经济利益(就减少了对心理健康住院服务的使用而言)。试用注册当前对照试验,ISRCTN注册号:16166070。于2019年2月5日注册。服务水平的患者利益(增加使用循证心理疗法的机会)和对NHS的经济利益(就减少对心理健康住院服务的使用而言)。试用注册当前对照试验,ISRCTN注册号:16166070。于2019年2月5日注册。服务级别的患者利益(增加使用循证心理疗法的机会)和对NHS的经济利益(就减少对心理健康住院服务的使用而言)。试用注册当前对照试验,ISRCTN注册号:16166070。于2019年2月5日注册。
更新日期:2020-04-22
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