South West Liver Unit, University Hospitals Plymouth NHS Trust, Plymouth, UK
Peninsula Medical School, University of Plymouth, Plymouth, UK.
BMJ Open. 2022 May 18;12(5):e060498. doi: 10.1136/bmjopen-2021-060498.
In the UK, alcohol use is the main driver of chronic liver disease and each year results in over 1 million unplanned hospital admissions and over 25 000 deaths from alcohol-related liver disease (ArLD). The only effective treatment to prevent progression of liver damage is reducing or ceasing alcohol consumption. Psychological and pharmacological therapies for alcohol misuse are ineffective in patients with ArLD. Functional imagery training (FIT) is a novel psychological therapy that builds on motivational interviewing techniques with multisensory imagery. This pilot trial aims to test the feasibility of training alcohol liaison nurses to deliver FIT therapy and of recruiting and retaining patients with ArLD and alcohol dependence to a randomised trial of FIT and treatment as usual (TAU) versus TAU alone.
This is a randomised pilot trial of FIT and TAU versus TAU alone in 90 patients with ArLD and alcohol dependence admitted to one of four UK centres. The primary objectives are to estimate rates of screening, recruitment, randomisation, retention, adherence to FIT/TAU and a preliminary assessment of the FIT intervention in the ArLD population. Data from the pilot study will be used to finalise the design of a definitive randomised controlled trial to assess the effectiveness and cost-effectiveness of FIT. The proposed primary outcome measure for the definitive trial is self-reported alcohol use assessed using timeline follow-back.
Research ethics approval was given by the Yorkshire and Humber-Bradford Leeds Research Ethics Committee (reference: 21/YH/0044). Eligible patients will be approached and written informed consent obtained prior to participation. Results will be disseminated through peer-reviewed open access journals, international conferences and a lay summary published on the Trials Unit website and made available to patient groups.
ISRCTN41353774.
在英国，酒精使用是导致慢性肝病的主要原因，每年有超过 100 万例非计划性住院和 25000 多例与酒精性肝病（ArLD）相关的死亡。预防肝损伤进展的唯一有效治疗方法是减少或停止饮酒。针对 ArLD 患者的心理和药物治疗对酒精滥用无效。功能性意象训练（FIT）是一种新颖的心理治疗方法，它建立在动机访谈技术的基础上，结合多感官意象。这项试点试验旨在测试培训酒精联络护士提供 FIT 治疗的可行性，以及招募和保留患有 ArLD 和酒精依赖的患者参加 FIT 和常规治疗（TAU）与单独 TAU 的随机试验的可行性。
这是一项针对 ArLD 和酒精依赖患者的 FIT 和 TAU 与单独 TAU 的随机试点试验，共纳入来自英国四个中心的 90 名患者。主要目的是评估筛查、招募、随机分组、保留率、对 FIT/TAU 的依从性以及在 ArLD 人群中对 FIT 干预的初步评估。来自试点研究的数据将用于最终确定一项评估 FIT 有效性和成本效益的确定性随机对照试验的设计。该研究的主要结局指标是使用时间线随访评估的自我报告饮酒量。
该研究已获得约克郡和亨伯-布拉德福德利兹研究伦理委员会的伦理批准（参考号：21/YH/0044）。合格的患者将在参与研究之前被接触并获得书面知情同意。研究结果将通过同行评审的开放获取期刊、国际会议以及在 Trials Unit 网站上发表的通俗易懂的摘要进行传播，并提供给患者群体。
ISRCTN41353774。
