Condition category
Mental and Behavioural Disorders
Date applied
12/06/2012
Date assigned
20/07/2012
Last edited
08/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Unhealthy alcohol use (alcohol consumption that is associated with varying degrees of risk to health, such as injury, trauma, physical, psychological or social harm) is a leading cause of illness and death among young adults. It is therefore crucial to develop preventive interventions targeting unhealthy alcohol use. Face-to-face brief interventions targeting alcohol use are considered effective in primary care settings, but young individuals tend to have limited contacts with the health care system and are therefore unlikely to receive any intervention. As a result, electronic brief interventions have been developed that can reach a broad population at a relatively low cost and potentially impact the public health system. Electronic screening and brief interventions (E-SBI) targeting alcohol use are effective among college students, but more evidence is needed in order to evaluate E-SBI designed for young individuals in other settings. There is also a lack of knowledge about the primary prevention effects of these interventions on, for example, moderate drinkers. The aim of this study is to evaluate the effectiveness of a proactive E-SBI providing personalized feedback and information on alcohol use and its consequences among young men in the general population, to determine how young men will use E-SBI to obtain information on alcohol use and its consequences, and to evaluate how young men perceive the use of Internet to deliver preventive interventions. We think that E-SBI will decrease later alcohol use and related consequences among individuals with unhealthy alcohol use, and will prevent the increase of alcohol use among individuals without unhealthy alcohol use.

Who can participate?
The study participants will come from a population-based sample of 20-year-old men recruited from among participants in the Cohort Study on Substance Use Risk Factors (C-SURF).

What does the study involve?
Participants will be randomly allocated to either receive electronic personalized feedback (intervention group) or to not receive feedback (control group), and will be followed up at 1 month and at 6 months. The electronic personalized feedback includes self-assessment of current alcohol use and consequences, personalized feedback on alcohol use, and general information on alcohol use and its consequences (i.e., factsheets). Participants who report unhealthy alcohol use are encouraged to modify their drinking habits, and are presented with the rationale for risks associated with their current use of alcohol. Participants have the opportunity to print their personalized feedback form, and are able to access a section containing general information on alcohol use and its consequences. Participants in the control group complete the same baseline assessment as do members of the intervention group, but neither receive personalized feedback nor have access to the general information section on the website. The approximate time to complete the baseline assessment is three minutes. All participants are asked if they think that the Internet is a suitable option for providing personalized information about substance use.

What are the possible benefits and risks of participating?
There are several benefits from this study. The direct benefits include improvement in drinking habits if E-SBI proves to be effective, and the assessments and other information that participants will receive as feedback might give them a heightened awareness of their drinking habits and encourage them to drink less alcohol. The major risk in this research is breach of confidentiality, but great effort have been made to minimize that risk as much as possible. Electronic interventions have no reported or known side effects. The possible risk of harm to participants caused by this study is limited; therefore the potential benefits outweigh any potential risks.

Where is the study run from?
Lausanne University Hospital, Lausanne, Switzerland.

When is the study starting and how long is it expected to run for?
The recruitment starts in June 2012 and will last until July 2014.

Who is funding the study?
The Swiss National Science Foundation (Switzerland).

Who is the main contact?
Nicolas Bertholet
nicolas.bertholet@chuv.ch  

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicolas Bertholet

ORCID ID

Contact details

Alcohol Treatment Center
Lausanne University Hospital
Beaumont 21b
P2
02
Lausanne
1011
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

135538 Swiss National Science Foundation

Study information

Scientific title

Electronic alcohol screening and brief intervention (E-SBI) for young adults:a randomized controlled trial

Acronym

SSYPA

Study hypothesis

It is hypothesized that E-SBI will decrease later alcohol use and related consequences among individuals with unhealthy alcohol use and will prevent the increase of alcohol use among individuals without unhealthy alcohol use.

Ethics approval

Ethics for the Research on Human Beings (Cantonal commission) 22 August 2011 ref: 260/2011

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alcohol use

Intervention

Web based brief intervention and information on alcohol use and its consequences (primary and secondary prevention intervention dependending on alcohol use level, duration: approx. 10 minutes, web-based)

Comparator: No intervention

Follow-up at 1 and 6 month

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Self reported alcohol use:
1. Weekly alcohol consumption (number of drinks per week, where one drink contains 10g of ethanol)
2. Monthly frequency of Risky Single Occasion Drinking episodes (RSOD corresponding to 6 or more drinks per occasion)

Secondary outcome measures

1. Number of consequences due to alcohol
1.1. Was injured or injured someone else
1.2. Had a hangover
1.3. Missed a class or work
1.4. Performed poorly at work
1.5. Did something that was later regretted
1.6. Had a blackout
1.7. Got into an argument or fight with friends
1.8. Had unplanned sex
1.9. Had unprotected sex
1.10. Damaged property
1.11. Had problems with the police
1.12. Received medical treatment
1.13. Observed negative impact on physical health and observed negative impact on mental health
2. Computed Blood Alcohol Concentration (BAC), based on maximum reported alcohol
3. Presence of unhealthy alcohol use ( ¡Ý 21 drinks per week or at least one RSOD episode per month)
4. Use of the website (number of visits on information pages)

Overall trial start date

01/07/2012

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Study participants are recruited among partcipants to the Cohort Study on Substance Use Risk Factors (C-SURF)
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/2012

Recruitment end date

31/07/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

Alcohol Treatment Center
Lausanne
1011
Switzerland

Sponsor information

Organisation

Swiss National Science Foundation (Switzerland)

Sponsor details

Wildhainweg 3
PO Box 8232
Berne
3001
Switzerland

Sponsor type

Government

Website

http://www.snf.ch/E/Pages/default.aspx

Funders

Funder type

Government

Funder name

Swiss National Science Foundation (Switzerland) ref: 135538

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26642329

Publication citations

Additional files

Editorial Notes

08/12/2015: Publication reference added.