ISRCTN41353774已完成未知
Pilot randomised trial of functional imagery training plus treatment as usual versus treatment as usual alone to reduce alcohol-related harm in patients with alcohol-related liver disease admitted to hospital
niversity Hospitals Plymouth NHS Trust0 个研究点目标入组 54 人开始时间: 2021年3月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35584873/ (added 20/05/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38286518/ (added 09/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult patients >=18 years
- •2. Able and willing to provide informed consent
- •3. Clinical diagnosis of ArLD by at least one of the following methods
- •3.1. Radiological appearance of fatty infiltration of the liver or cirrhosis
- •3.2. Histological findings of cirrhosis or alcoholic steatohepatitis
- •3.3. Signs consistent with chronic liver disease on physical examination
- •4. High risk alcohol consumption (>50 units/week for males and >35 units/week for females) within 4 weeks prior to hospital admission
- •5. AUDIT score >15 during current hospital admission
- •6. Diagnosis of alcohol dependence as defined in ICD-10 meeting at least three of the following conditions:
- •6.1. Strong desire or sense of compulsion to take alcohol
- •6.2. Difficulties in controlling alcohol-consuming behaviour in terms of its onset, termination, or levels of use
- •6.3. A physiological withdrawal state when alcohol use has ceased or been reduced, as evidenced by: the characteristic withdrawal syndrome; or use of alcohol with the intention of relieving or avoiding withdrawal symptoms
- •6.4. Evidence of tolerance, such that increased doses of alcohol are required in order to achieve effects originally produced by lower doses
- •6.5. Progressive neglect of alternative pleasures or interests because of alcohol use, increased amount of time necessary to obtain or consume alcohol or to recover from its effects
- •6.6. Persisting with alcohol use despite clear evidence of overtly harmful consequences
排除标准
- •1. Any condition with an estimated life expectancy of less than 6 months
- •2. Patients participating in concurrent interventional research
- •3. Participants who have significant difficulties in adequate understanding of English such that they are unable to benefit from the trial intervention or sufficiently understand the trial documentation
研究者
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