Plain English Summary
Background and study aims
Binge drinking is a term used to describe the consumption of lots of alcoholic drinks in a short period of time (hours to days) with the sole purpose of becoming drunk (intoxicated). Binge drinking is well known to have many negative effects on a person’s physical and mental health, particularly in young people whose brains are still developing. There is some evidence to suggest that people who regularly binge drink are more sensitive to environmental stimuli related to alcohol, such as advertising. This is called attentional bias. An attentional bias towards alcohol may make a person who binge drinks more likely to engage in that behaviour. It may also make it harder for them to not drink, even if that is what they feel they would prefer, because it affects their will power. The aim of this study is to test an online attentional bias modification programme. The study will assess whether people who engage in binge drinking behaviour show reduced attentional bias towards alcohol-related stimuli following completion of the programme.
Who can participate?
Adults aged 18-29 who exhibit binge drinking behaviour and have a good command of French.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) take part in 8 online sessions of the attentional bias modification programme. Those in group 2 (control group) take part in 8 online sessions of a modified version of the attentional bias modification programme; it is not considered to have any therapeutic effect for the participant. All participants take part in the programme sessions over a four week period. Each session takes approximately 20 minutes to complete. Participants are asked to complete questionnaires at the start of the study, at the end of the 8 programme sessions, and again 1 month later.
What are the possible benefits and risks of participating?
There are foreseeable risks related to the use of the Attentional Bias Modification procedure. Meanwhile, we expect two potential benefits to the participants, a possible reduction in alcohol consumption after the completion of eight sessions of the intervention task and a monetary remuneration at the end of the study.
Where is the study run from?
University of Geneva (Switzerland)
When is the study starting and how long is it expected to run for?
July 2013 to March 2016
Who is funding the study?
Information Technology Commission of the University of Geneva (Switzerland)
Who is the main contact?
Dr G Ceschi
Ekaterina.Plys@unige.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Grazia Ceschi
ORCID ID
http://orcid.org/0000-0002-2065-6870
Contact details
40
boulevard du Pont-d'Arve
Geneva
1211
Switzerland
+41 22 379 8064
Ekaterina.Plys@unige.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Social Affaire and Health Department of the State of Geneva Grant: N 180490
Study information
Scientific title
Internet-based cognitive bias modification for binge drinking prevention: protocol for a randomised controlled trial
Acronym
iCBM-A Binge Drinking
Study hypothesis
1. Binge drinkers trained to attend to alcohol-unrelated stimuli will decrease their attentional bias towards alcohol and their alcohol consumption. We expect this effect to last for at least one month.
2. The attentional bias modification will mediate changes in alcohol consumption. Additionally, we will explore the effects of the Cognitive Bias Modification of Attention procedure on participants’ subjective craving for alcohol. We expect that the reduction of attentional bias will be accompanied by a decrease in craving.
Ethics approval
Ethics Committee of the University of Geneva, 19/07/2013.
Study design
Randomised controlled singe-centre interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Alcohol consumption (binge drinking behaviour)
Intervention
1. Intervention group: eight sessions of an internet-based attentional bias modification programme. During the intervention, 95% of the probes will appear at the spatial location previously occupied by the alcohol-unrelated picture (contingency ratio of 95:05). The intervention takes place over four weeks, and each session lasts about 20 minutes.
2. Control group: eight sessions of the internet-based control task. For the control sessions, probes will replace alcohol-related pictures as often as alcohol-unrelated pictures (contingency of 50:50). The sessions take place over four weeks, and each session lasts about 20 minutes.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Baseline and post-intervention:
1. Self-reported assessment of alcohol consumption during last two weeks (Time-Line-Follow-Back)
2. Attentional bias towards alcohol (Dot Probe Detection Task)
One month follow-up:
1. Self-reported assessment of alcohol consumption during last two weeks (Time-Line-Follow-Back)
Secondary outcome measures
1. Self-reported assessment of binge drinking behaviour. Participants will be asked to evaluate their average alcohol consumption during last six months using the following questions:
1.1. How many times per week do you consume alcoholic drinks?
1.2. On a typical day when you are drinking, how many alcoholic drinks do you have?
2. Self-reported drug consumption (Alcohol, Smoking and Substance Involvement Screening Test)
Baseline:
1. Self-reported craving for alcohol (Alcohol Craving Experience Questionnaire)
2. Self-reported readiness to change alcohol use (The Stages of Change Readiness and Treatment Eagerness Scale)
3. Self-reported depressive symptoms (Beck depression inventory)
4. Self-reported anxiety (Spielberger State-trait anxiety inventory)
5. Social desirability (Crowne-Marlowe Social Desirability Scale)
6. Demographic data
Post-intervention and one month follow-up:
1. Self-reported craving for alcohol (Alcohol Craving Experience Questionnaire)
Overall trial start date
15/07/2013
Overall trial end date
30/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18-29
2. Presents with binge drinking behaviour: consumption of over five (for men) or four (for women) standard alcoholic drinks in a row at least once per fortnight during the previous 6 months
3. Attentional bias towards alcohol
4. Internet access
5. Good command of French
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Scores more than 3 on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) for all addictive substances except alcohol and nicotine
2. No psychotropic medication change or dosage change within the past three months from study start
3. Introduction of, or change in, psychotherapeutic treatments within 3 months preceding study start
Recruitment start date
20/08/2015
Recruitment end date
15/03/2016
Locations
Countries of recruitment
Switzerland
Trial participating centre
University of Geneva
Abnormal Emotion and Trauma Laboratory
40, boulevard du Pont-d'Arve
Geneva
1211
Switzerland
Sponsor information
Organisation
University of Geneva
Sponsor details
Abnormal Emotion and Trauma Laboratory
40
boulevard du Pont-d'Arve
Geneva
1211
Switzerland
Sponsor type
University/education
Website
http://www.unige.ch/fapse/psychoclinique/upcet-1/
Organisation
Geneva University Hospitals
Sponsor details
Service d'addictologie
70C
Grand pré
Geneva
1206
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Information Technology Commission of the University of Geneva (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Social Affaire and Health Department of the State of Geneva Grant: N 180490
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The protocol of our randomized controlled trial is expected to be published in a peer-reviewed journal Frontiers in Psychiatry in November 2015. The results about efficacy of our internet-based cognitive bias modification platform are planned to be submitted to international peer-reviewed journals after the end of the experiment (expected for December 2016).
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary