Efficacy of physician-delivered brief counselling intervention for binge drinkers: randomised controlled trial in primary care practice

ISRCTN	ISRCTN10111467
DOI	https://doi.org/10.1186/ISRCTN10111467
Protocol serial number	binger01
Sponsor	Brain and Mind Foundation (Fundacion Cerebro y Mente) (Spain)
Funder	Brain and Mind Foundation (Fundacion Cerebro y Mente) (Spain)

Submission date: 30/07/2008
Registration date: 21/08/2008
Last edited: 24/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gabriel Rubio
Scientific

Hospital Universitario 12 de Octubre
Department of Psychiatry
Avda Cordoba s/n
Madrid
28047
Spain

Phone	+34 63 920 1870
Email	garuva@inicia.es

Study information

Primary study design	Interventional
Study design	Multi-centre, randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy of brief interventions (BI) for binge drinkers
Study acronym	BINGER
Study objectives	To test the effect of brief interventions (BI) in a sample consisting exclusively of binge drinkers. Please note that, as of 24/11/2008, the following amemndments were made to this trial record due to errors in inforamtion provided at time of registration: 1. Start and end dates were amended from 01/11/2008 and 01/11/2008 to 01/03/2003 and 01/03/2006, respectively 2. The target number of recruitment was changed from 2,433 to 752. The former is the number of participants who screened positive (i.e. binge drinking pattern and Alcohol Use Disorders Identification Test [AUDIT] score 15 or lower), whereas the latter is the number of participants who were randomised to the trial arms
Ethics approval(s)	Ethics Committee of the University Hospital "12 de Octubre" (Hospital Universitario 12 de Octubre). Date of approval: 23/04/2008 (ref: 2008-45-2)
Health condition(s) or problem(s) studied	High-risk alcohol drinkers
Intervention	This is a randomised controlled trial with a 12-month follow-up period conducted by 74 physicians in 20 primary care centres in Spain. The brief intervention by the physician consisted of 2 short counselling sessions 4 weeks apart. Each 10 to 15-minute face-to-face counselling session was offered within the context of routine patient care by a physician using a scripted workbook. The intervention workbook included a review of alcohol-related health effects, a pie chart displaying the frequency of different types of at-risk drinkers, a list of methods for cutting down drinking, a treatment contract, and cognitive behavioural exercises. Subjects assigned to the control group received a booklet on general health issues and were followed up at 6 and 12 months. They were instructed to address any health concerns in their usual manner. Please use the following contact details to request a patient information sheet: Hospital Universitario 12 de Octubre Department of Psychiatry Avda Cordoba s/n Madrid, 28047 Spain Tel: +34 91 390 8022
Intervention type	Other
Primary outcome measure(s)	Change in alcohol use: number of binge episodes (>5 drinks for men and >4 drinks for women on a single occasion) in the previous month and the percentage of bingers, assessed at baseline, 6 and 12 months.
Key secondary outcome measure(s)	Changes in weekly alcohol consumption and rates of excessive drinking in the previous 7 days (more than 18 drinks per week for men and more than 13 drinks per week for women), assessed at baseline, 6 and 12 months.
Completion date	01/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	752
Key inclusion criteria	All adults patients aged 18 to 65 years of age will be asked to undergo alcohol use disorders screening (Alcohol Use Disorders Identification Test [AUDIT]) (Rubio et al., 1998) by their primary care physicians (PCPh). All patients who screen positive will be contacted and invited to participate in a face-to-face interview to determine their eligibility for the trial. Patients will be eligible for the randomised trial if they report a pattern of binge drinking and score 15 or lower on the AUDIT (scores above 15 were referred to the Drug Abuse Programme for Treatment). Patients eligible for the study will be binge drinkers, defined as men who had drunk 5 or more standard drinks per occasion (12.8 g of alcohol per drink) on 1 or more occasions in the previous month. Women will be included in the study sample if they had drunk 4 or more standard drinks per occasion on 1 or more occasions in the previous month. Rubio, G., Bermejo, J., Caballero, C., Santo-Domingo, J. Validación del test de identificación de trastornos por uso de alcohol (AUDIT) en atención primaria (Spanish validation of the Alcohol Use Disorders Identification Test [AUDIT] in primary care). Rev Clin Esp 1998; 198: 11-14.
Key exclusion criteria	1. Pregnant women 2. Plan to move out of the area within the year 3. Do not have a telephone 4. Those who are already participating in an alcohol intervention programme 5. Those who have an Axis I psychiatric disorder (American Psychiatric Association [APA] 2000) other than substance abuse that, in the judgment of the PCPh, prevents them from participating 6. Unable to complete the informed consent
Date of first enrolment	01/03/2003
Date of final enrolment	01/03/2006

Locations

Countries of recruitment

Spain

Study participating centre

Hospital Universitario 12 de Octubre

Madrid
28047
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes