Condition category
Mental and Behavioural Disorders
Date applied
27/05/2015
Date assigned
05/06/2015
Last edited
05/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://icbm.unige.ch/

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

Publication citations

Additional files

Editorial Notes