RecruitingACTRN12619000710123

When drugs don't work: A psychological intervention for Alcohol Related Liver Disease.

Psychological Treatment for Alcohol Related Liver Disease: Assessing Patient Engagement, Retention, and Drinking Behaviour.


Sponsor

Metro South Health

Enrollment

35 participants

Start Date

Jul 1, 2019

Study Type

Interventional

Conditions

Summary

Alcoholic hepatitis (AH) poses a significant burden on public tertiary hospitals. Medication for AH has recently been demonstrated to be ineffective in a large high-quality study. Sustained alcohol abstinence is the strongest predictor of long-term survival. Behavioural interventions to promote abstinence in AH have not been systematically assessed. We propose to trial an early and intense Cognitive Behavioural Therapy (CBT) program for patients at high risk of poor outcome of alcohol-related liver disease/severe AH and evaluate treatment outcome as a matter of quality assurance.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • All Alcoholic Hepatitis (AH) patients will be diagnosed and medically managed by liver disease specialists (Hepatologists) and Addiction specialist. Liver biopsy remains the gold standard for diagnosis, however indications for physician practice varies. While biopsy is the preferred inclusion criterion, absence will not be an exclusion criterion. For patients without liver biopsy, inclusion requires 1). Consistent alcohol risk history, 2). Absence of other acute liver injury risk; 3) at least 2/3 of: jaundice < 8 weeks, AST/ALT ratio > 2; neutrophilia. Further characterised on AH severity (Maddrey Discriminant Function 32) and the presence of cirrhosis.

Exclusion Criteria1

  • As this is an effectiveness study all patients eligible for enrolment in the hospital based program will be included. Such eligibility requires patients to be able to provide written informed consent.

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Interventions

Patients are referred to this outpatient alcohol and drug service following inpatient hospital admission, by their General Practitioner, or self-referral. Initial assessment is conducted by a clinical

Patients are referred to this outpatient alcohol and drug service following inpatient hospital admission, by their General Practitioner, or self-referral. Initial assessment is conducted by a clinical nurse or social worker. Initial assessment includes standardised review of psychosocial history, dependency symptoms, dependence severity, and comorbid drug use. Suitable patients are enrolled in the Cognitive-Behavioural Therapy (CBT) for Alcohol Use Disorder (AUD) program. When enrolled in the program patients receive a 1-hour consult with an addiction specialist physician, comprising a medical review, physical examination, assessment of suitability for prescription of adjunct pharmacotherapy (e.g. Acamprosate or naltrexone), and a written report to their primary health-care provider with recommendations for ongoing management. The CBT for AUD program comprises 8x 1hour face-to-face outpatient sessions over 3 months with a clinical psychologist. Following three months of abstinence, less frequent contact is maintained. Breathalyser readings are mandatory and routinely undertaken prior to each session. Standardised assessments are administered each session, monitoring: drinking behaviours (quantity, frequency), adherence to adjunct pharmacotherapy, alcohol craving, and alcohol refusal self-efficacy. The first session is devoted to obtaining a thorough assessment of the problem (including a comprehensive psychometric battery), education about the potential harms associated with alcohol, and affirming commitment to alcohol abstinence for the duration of the program. A CBT intervention plan is then developed collaboratively based on individual needs. The most common targets for intervention include: identification and alteration of alcohol expectancies, enhancement of drinking refusal self-efficacy, craving management, development of alternative coping strategies, problem-solving skills training, goal setting, and lifestyle improvement. The Tailored Alcoholic Hepatitis (AH) Intervention will match for the existing generic face-to-face CBT Intervention historical benchmark for length of treatment (3 months) and therapist contact (8 hours). When possible, AH patients will be assessed as inpatients, including 1x addiction specialist physician assessment and 1x clinical psychologist review. The clinical psychologist will outline the services available to the patient, offering the CBT for AUD program as a means of ongoing support as an outpatient. Hospital discharge is determined by the treating medical team, not this service. Post-inpatient hospital discharge, patients will either enrol in The CBT for AUD program or receive 2 x weekly 20 min ‘booster’ telephone sessions for 3 months (totalling 8 hours). The mode of treatment delivery (face-to-face or telephone) will be determined by geographical feasibility. Face-to-face sessions are preferred. Psychometric assessment and intervention targets will not be affected by modality, though AH patients are likely to require greater emphasis on health and lifestyle factors associated with adherence to treatment for AH. Treatment adherence is determined by session attendance, psychometric assessment at each session, and patient self-report of drinking behaviour. This study is a non-randomised trial. All patients will receive the intervention. All patients enrolled in the CBT for AUD program consent for their anonymous data to be used for program evaluation. Non-consenting patients will not be included in the dataset but will receive the intervention. Participation is voluntary and patients may withdraw a any time without penalty. Patients who do not achieve abstinence will be offered ongoing support or referral options appropriate to their condition and circumstances. Patient outcomes post the 3-month treatment period will not be included in this study.


Locations(1)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12619000710123


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