Mental imagery to reduce alcohol-related harm in patients with alcohol-related liver damage (MIRAGE)

Not Applicable

Completed

• Conditions: Reducing alcohol use in patients with alcohol-related liver disease; Digestive System

• Registration Number: ISRCTN41353774
• Lead Sponsor: niversity Hospitals Plymouth NHS Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-12
• Study Completion: 2022-11-23
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility outcomes:<br>1. Number of patients screened and recruited<br>2. Retention rate at 90 and 180 days measured by number of recruited patients attending follow-up visits<br>3. Fidelity of delivery of FIT and TAU (trained FIT practitioner will check each ALN’s fidelity early in the trial using dedicated fidelity assessment tools). Feedback and supervision throughout the trial<br>4. Intervention engagement – number of successful FIT phone calls and visits by 180 days<br>5. Completeness of data collection by 180 days (to include number of completed questionnaires, number of missing items within a questionnaire by time point)