A Controlled Trial of Extended Brief Interventions in Alcohol Dependent Patients

NCT01060397 | Completed DMC

• 2 other identifiers: PB-PG-0408-15077NIHR CRN study ID 7889
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

Heavy alcohol consumption leads to various health problems and is now recognised to be an important public health problem. This is evidenced by the huge media attention recently focused on the use and misuse of alcohol, particularly by younger patients. At least 1 in 20 of the population in the UK are physically and psychologically dependent on alcohol. This not only has consequences for the physical and psychological well-being of these patients, but has adverse consequences for their family, work life and society in general. Current treatments are mostly delivered in specialist units, which are few in number meaning that few patients get access to these services. This leads to a vicious cycle which results in multiple hospital admissions, ineffective treatments and continual drinking. It is therefore vital the investigators develop alternative effective treatments for these patients which can interrupt this vicious cycle. In patients who drink heavily, but are not yet alcohol-dependent, a treatment called brief intervention can help reduce overall alcohol consumption, and improve health and wellbeing. However, whether a similar intervention can help alcohol-dependent patients has not yet been established. In this study, the investigators aim to identify, treat and support alcohol-dependent individuals. Using an enhanced form of BI (termed extended brief intervention, EBI) as the basis of clinical care, the investigators will undertake a randomised trial comparing EBI with usual clinical care. The investigators will use various clinical and behavioural measures to assess the effectiveness of this treatment. The investigators will also be asking patients how they felt, and what they think of their treatment and the professionals delivering that treatment. If EBI is shown to be effective and is not too costly, it could provide a national framework for treatment of alcohol-dependent patients. This could potentially improve both the opportunities to access treatment and the choice of treatments available to patients. The investigators hypothesis is that Extended Brief Interventions (EBI) delivered to alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN) will be effective in reducing overall alcohol consumption and improving the standard measures of alcohol dependence.

Conditions

Alcohol Dependence

Keywords

Alcohol; nurse; alcohol dependence; acute hospital; brief interventions

Outcome Measures

Primary Outcomes (1)

• Alcohol Use Disorders Identification Test (AUDIT)

  Baseline, twelve weeks and six months

Secondary Outcomes (1)

• Measure of Dependence (Leeds Dependency Questionnaire)

  baseline, 12 weeks and 6 months

Study Arms (2)

Extended Brief Intervention

EXPERIMENTAL

FRAMES motivational interviewing approach

Behavioral: Extended Brief Intervention

Control

EXPERIMENTAL

Usual care

Behavioral: Control

Interventions

Extended Brief Intervention BEHAVIORAL

Frames motivational interviewing approach

Extended Brief Intervention

Control BEHAVIORAL

Usual care

Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a score equal to or greater than 16 on the AUDIT screening tool.

You may not qualify if:

• Patient's known to be intravenous drug abusers.
• Patients unable to give informed consent.
• Patients whose medical co-morbidity requires requiring frequent or long term hospital admission. These will include patients who are/have;
• Comatose /unconscious
• End Stage Chronic Liver Disease
• Dementia
• Congestive Cardiac Failure stage III or IV
• Acute Pancreatitis
• Head Injury with abnormalities on CT scan
• Cerebral Vascular Accident (CVA)
• Chronic Obstructive Pulmonary Disease (COPD)
• Other chronic conditions where an admission of 1 month or more is required.
• Patient's presently recruited to any other research trial

Sponsors & Collaborators

• Southport and Ormskirk Hospital NHS Trust: lead

Study Sites (1)

Southport and Ormskirk NHS Trust

Southport, England, L39 2AZ, United Kingdom

Location

Related Publications (1)

• Owens L, Butcher G, Gilmore I, Kolamunnage-Dona R, Oyee J, Perkins L, Walley T, Williamson P, Wilson K, Pirmohamed M. A randomised controlled trial of extended brief intervention for alcohol dependent patients in an acute hospital setting (ADPAC). BMC Public Health. 2011 Jul 4;11:528. doi: 10.1186/1471-2458-11-528.

  PMID: 21726445 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Munir Pirmohamed, PhD FRCP

  The University of Liverpool

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Lynn Owens

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 2, 2010
• Study Start: November 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2013
• Last Updated: November 26, 2014

Record last verified: 2010-01

Locations

GB (1)