Freeman Daniel, Emsley Richard, Rosebrock Laina, Morrison Anthony, Chapman Kate, Common Stephanie, Dudley Robert, Isham Louise, Kabir Thomas, Kenny Alex, Freeman Jason, Beckley Ariane, Westgate Verity, Rouse Natalie, Leal José, McGovern Megan, Waite Felicity
Department of Experimental Psychology, University of Oxford, Oxford, UK
Oxford Health NHS Foundation Trust, Oxford, UK.
BMJ Open. 2025 Jun 6;15(6):e104580. doi: 10.1136/bmjopen-2025-104580.
Persecutory delusions are very common in severe mental health disorders such as schizophrenia. Existing treatments often do not work well enough. We developed a face-to-face theory-driven psychological intervention, called Feeling Safe, that produces very large reductions in persistent persecutory delusions. The challenge now is to make Feeling Safe widely available. So, we developed a 6-month supported online version, called Feeling Safer. The aim is an intervention that patients can easily access and use, reduces persecutory delusions and can be supported by a range of mental health professionals in less contact time than face-to-face therapy. Initial proof of concept testing of Feeling Safer was very encouraging. In a randomised controlled trial, we now plan to test whether Feeling Safer is efficacious for patients and can be successfully delivered by any of three different mental health staff groups (peer-support workers, graduate psychologists and cognitive behavioural therapy (CBT) therapists). We will also test whether Feeling Safer works equally across gender, age, ethnicity and cognitive functioning (moderation) and whether Feeling Safer works via the targeted psychological processes (mediation).
The study design is a multicentre, single-blind (outcome assessor), parallel, four-arm randomised controlled trial; 484 patients with persistent persecutory delusions will be randomised to one of the four conditions (1:1:1:1): Feeling Safer (added to treatment as usual (TAU)) supported by peer-support workers, or Feeling Safer (added to TAU) supported by graduate mental health workers including assistant psychologists, or Feeling Safer (added to TAU) supported by CBT therapists or TAU. Feeling Safer will be provided for 6 months with a staff member. Assessments will be conducted at 0, 3, 6 and 9 months by research assistants blind to group allocation. The primary outcome is severity of persecutory delusions at 6 months rated with the Psychotic Symptoms Rating Scale-Delusions. The secondary outcomes are other psychiatric symptoms (depression, anxiety, insomnia, agoraphobia and paranoia), psychological well-being, recovery, activity and health-related quality of life. Analysis will be conducted under a treatment policy strategy following the intention-to-treat principle, incorporating data from all participants including those who do not complete treatment. Moderation and mediation will be tested. A within-trial cost-effectiveness analysis will be conducted of Feeling Safer compared with TAU.
The trial has received ethical approval from the NHS Health Research Authority (23/LO/0951). Informed consent will be obtained from all participants. A key output will be an open-access publication in a peer-reviewed journal reporting on the clinical effectiveness of a high-quality supported online programme for the treatment of persecutory delusions that has the potential to be used at scale in mental health services.
ISRCTN93974770.
被害妄想在精神分裂症等严重精神健康障碍中非常常见。现有的治疗方法往往效果不够理想。我们开发了一种面对面的、基于理论的心理干预方法，称为“感到安全”，该方法能使持续性被害妄想大幅减少。现在面临的挑战是让“感到安全”得到广泛应用。因此，我们开发了一个为期6个月的有支持的在线版本，称为“更感安全”。目标是开发一种患者能够轻松获取和使用的干预方法，减少被害妄想，并且能在比面对面治疗更少的接触时间内得到一系列精神健康专业人员的支持。“更感安全”的初步概念验证测试非常令人鼓舞。在一项随机对照试验中，我们现在计划测试“更感安全”对患者是否有效，以及是否能由三个不同的精神健康工作人员群体（同伴支持工作者、研究生心理学家和认知行为疗法（CBT）治疗师）中的任何一个成功实施。我们还将测试“更感安全”在性别、年龄族裔和认知功能方面是否同样有效（调节作用），以及“更感安全”是否通过目标心理过程起作用（中介作用）。
本研究设计为一项多中心、单盲（结果评估者）、平行、四臂随机对照试验；484名患有持续性被害妄想的患者将被随机分配到四个条件之一（1:1:1:１）：由同伴支持工作者提供支持的“更感安全”（添加到常规治疗（TAU）中），或由包括助理心理学家在内的研究生精神健康工作者提供支持的“更感安全”（添加到TAU中），或由CBT治疗师提供支持的“更感安全”（添加到TAU中），或TAU。“更感安全”将由一名工作人员提供6个月。评估将由对分组情况不知情的研究助理在0、3、6和9个月时进行。主要结局是在6个月时用《精神病症状评定量表 - 妄想》评定的被害妄想严重程度。次要结局是其他精神症状（抑郁、焦虑、失眠、广场恐惧症和偏执狂）、心理健康、康复、活动及与健康相关的生活质量。将按照意向性分析原则，在治疗策略下进行分析，纳入所有参与者的数据，包括那些未完成治疗的参与者。将测试调节作用和中介作用。将对“更感安全 ”与TAU进行试验内成本效益分析。
该试验已获得英国国家医疗服务体系健康研究管理局的伦理批准（23/LO/0951）。将获得所有参与者的知情同意。一个关键成果将是在同行评审期刊上发表的开放获取出版物，报告一个高质量的有支持的在线项目治疗被害妄想的临床有效性，该项目有可能在精神健康服务中大规模使用。
ISRCTN93974770
