Strelchuk Daniela, Wiles Nicola, Turner Katrina M, Derrick Catherine, Zammit Stan
Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, Bristol, UK.
BMJ Open. 2020 Oct 1;10(10):e038620. doi: 10.1136/bmjopen-2020-038620.
Trauma can play an important role in the development of psychosis, yet no studies have investigated whether a trauma-focused psychological therapy could prevent the onset of psychosis in people at high risk of developing this condition. This study aims to establish whether it would be feasible to conduct a multicentre randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of eye movement desensitisation and reprocessing (EMDR) therapy to prevent the onset of psychosis in people with an at-risk mental state (ARMS).
METHODS/ANALYSIS: This is a single-arm trial with a nested qualitative study where all participants (target n=20) will be offered EMDR. Eligible participants are those who meet criteria for ARMS; have experienced a traumatic event before the onset of ARMS symptomatology; and have at least one symptom of post-traumatic stress disorder (PTSD). Participants will be followed up at 4, 8 and 12 months after the baseline assessment. The primary outcome measure is transition to psychosis, and secondary outcome measures include severity of psychotic symptoms, PTSD, depression, anxiety, impaired functioning, health status and resource use. The analysis will aim to establish the rates of recruitment and retention for a large-scale RCT. Interviews with therapists and patients will explore their views of the study and their experiences of delivering or receiving EMDR.
This protocol has been approved by the South West-Cornwall and Plymouth Research Ethics Committee (Reference 18/SW/0037). Findings will be disseminated through journal publications, conference presentations and meetings with service users, their families, mental health professionals and commissioners.
ISRCTN31976295.
创伤在精神病的发展过程中可能起重要作用，但尚无研究调查以创伤为重点的心理治疗能否预防处于精神病高发风险人群中精神病的发作。本研究旨在确定开展一项多中心随机对照试验（RCT）以调查眼动脱敏再处理（EMDR）疗法预防处于高危精神状态（ARMS）人群中精神病发作的临床疗效和成本效益是否可行。
方法/分析：这是一项带有嵌套定性研究的单臂试验，所有参与者（目标人数 = 20）都将接受EMDR治疗。符合条件的参与者是那些符合ARMS标准的人；在ARMS症状出现之前经历过创伤事件；并且至少有一项创伤后应激障碍（PTSD）症状。在基线评估后的4、8和12个月对参与者进行随访。主要结局指标是向精神病的转变，次要结局指标包括精神病症状的严重程度、PTSD、抑郁、焦虑、功能受损、健康状况和资源使用情况。分析旨在确定大规模RCT的招募和保留率。对治疗师和患者的访谈将探讨他们对该研究的看法以及他们提供或接受EMDR治疗的经历。
本方案已获得西南 - 康沃尔和普利茅斯研究伦理委员会批准（参考号18/SW/0037）。研究结果将通过期刊发表、会议报告以及与服务使用者、他们的家人、心理健康专业人员和专员的会议进行传播。
ISRCTN31976295。
