Internet-based cognitive bias modification for binge drinking prevention ('binge drinking' chez les jeunes: etude pilote de la prévention de l’alcoolisme par un réentrainement attentionnel en ligne)

ISRCTN ISRCTN23552252
DOI https://doi.org/10.1186/ISRCTN23552252
Secondary identifying numbers Social Affaire and Health Department of the State of Geneva Grant: N 180490
Submission date
27/05/2015
Registration date
05/06/2015
Last edited
08/05/2017
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

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

Study website

Contact information

Dr Grazia Ceschi
Scientific

40, boulevard du Pont-d'Arve
Geneva
1211
Switzerland

ORCiD logoORCID ID 0000-0002-2065-6870
Phone +41 22 379 8064
Email Ekaterina.Plys@unige.ch

Study information

Study designRandomised controlled singe-centre interventional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleInternet-based cognitive bias modification for binge drinking prevention: protocol for a randomised controlled trial
Study acronymiCBM-A Binge Drinking
Study objectives1. 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(s)Ethics Committee of the University of Geneva, 19/07/2013.
Health condition(s) or problem(s) studiedAlcohol consumption (binge drinking behaviour)
Intervention1. 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 typeBehavioural
Primary outcome measureBaseline 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 measures1. 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 study start date15/07/2013
Completion date30/05/2016

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit29 Years
SexBoth
Target number of participants80
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment20/08/2015
Date of final enrolment15/03/2016

Locations

Countries of recruitment

  • Switzerland

Study participating centre

University of Geneva
Abnormal Emotion and Trauma Laboratory
40, boulevard du Pont-d'Arve
Geneva
1211
Switzerland

Sponsor information

University of Geneva
University/education

Abnormal Emotion and Trauma Laboratory
40, boulevard du Pont-d'Arve
Geneva
1211
Switzerland

Website http://www.unige.ch/fapse/psychoclinique/upcet-1/
Geneva University Hospitals
Hospital/treatment centre

Service d'addictologie
70C, Grand pré
Geneva
1206
Switzerland

University Hospital of Geneva
Not defined

Funders

Funder type

University/education

Information Technology Commission of the University of Geneva (Switzerland)

No information available

Social Affaire and Health Department of the State of Geneva Grant: N 180490

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planThe 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).
IPD sharing plan

Editorial Notes

08/05/2017: Internal review