Condition category
Mental and Behavioural Disorders
Date applied
30/06/2011
Date assigned
05/09/2011
Last edited
06/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Several studies have assessed various forms of screening and interventions to change students’ drinking behaviour. This can be done online, asking people to complete a few questions and giving brief feedback and advice where it may be needed. Electronic screening and brief intervention (e-SBI) is as an efficient approach to reach large numbers of adolescents as a result of high levels of internet use among young people. This study aims to find out whether e-SBI works, and whether it is necessary to receive feedback or whether simply answering questions helps people to think about their drinking and to change it.

Who can participate?
All freshmen at Linköping University, Sweden

What does the study involve?
Participants are randomly allocated into three groups. The first group receive an e-mail asking them to participate in a short 9-question survey about alcohol habits. After completing the questionnaire they immediately receive feedback about their alcohol consumption. The second group are not contacted at all until the end of the study. The third group complete the questionnaire without getting feedback. After 3 months all three groups receive an email asking them to participate in a seemingly unrelated survey about students’ alcohol habits with no reference to the previous survey. All students at this time have an opportunity to receive personalised feedback.

What are the possible benefits and risks of participating?
The benefit could be that participants consider their alcohol habits and might change these to be more healthy. No risks are anticipated for the participants.

Where is the study run from?
Linköping University (Sweden)

When is the study starting and how long is it expected to run for?
September to December 2010

Who is funding the study?
Swedish Council for Working Life and Social Research (Sweden)

Who is the main contact?
Prof. Preben Bendtsen,
preben.bendtsen@liu.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Preben Bendtsen

ORCID ID

Contact details

Department of Medicine and Health
Linköping University
Linköping
5581 83
Sweden
+46 (0)70 232 4615
preben.bendtsen@liu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial of the effectiveness of electronic mail based alcohol intervention with university students: dismantling the assessment and feedback components

Acronym

Study hypothesis

The overall aim of the study is to evaluate the effectiveness of electronic screening and brief intervention (e-SBI), employing an randomised controlled trial (RCT) design that takes account of baseline assessment reactivity (and other possible effects of the research process) due to the similarity between the intervention and assessment content. The hypothesis is that assessment per se have an impact on drinking behaviour however to a lesser extent that the intervention.

Ethics approval

Regional Ethics Committee in Linköping, Sweden, 12/10/2010, ref: 2010/291-31

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

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

Condition

Alcohol risk/drinking behaviour

Intervention

The present study is designed in such a manner that the control group is as non contaminated as possible from the possible effects of research participation. Two kind of control groups will therefore be included in the study
1. A delayed intervention group that do not know they will get an intervention after 3 month
2. A “screening only” group without intervention at baseline who also do not know they will get an intervention after 3 months, when they will be offered an e-SBI following outcome assessment.

Students in the screening group (S) will receive a mail from the local student health care asking them to participate in a short 9 question survey concerning alcohol habits among students in Linköping. They will be informed that the survey is part of the university´s work with alcohol in general.

Students in the control group (C) will not be aware that they have been selected for a study before 3 months when students in all three groups (e-SBI, S and C) will receive a mail from the research group asking them to participate in a survey about students alcohol habits with no reference to the previous survey 3 month earlier with the research procedures otherwise identical to those used in Luleå.

After 3 month all students in both the intervention and control groups will receive a mail from the research group asking them to participate in a survey about students alcohol habits with no reference to the previous survey 3 month earlier. This is done in order minimise a Hawthorne effect in the intervention group i.e. being aware that the results will be compared with the first survey. The appearance of the two surveys, as well as their source, will be different from each other to protect against this possibility. All students will at this time receive a normative personalised feedback opportunity directly on the screen of their computer and have the possibility to print it out. The students will also automatically receive a mail with their feedback so they can read the feedback at a later stage.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Average alcohol consumption
2. Frequency of heavy episodic drinking
3. Maximal drinking at one occasion
Measured at baseline before they get a written feedback and after 3 months before another written feedback

Secondary outcome measures

Proportion of students with risky drinking, measured at baseline before they get a written feedback and after 3 months before another written feedback.

Overall trial start date

01/09/2010

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All freshmen at Linköping University, Sweden

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2010

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Linköping University
Linköping
5581 83
Sweden

Sponsor information

Organisation

Swedish Council for Working Life and Social Research (Sweden)

Sponsor details

FAS
Box 2220
Stockholm
10315
Sweden
+46 (0)87 754 070
fas@fas.se

Sponsor type

Research council

Website

http://www.fas.se

Funders

Funder type

Research council

Funder name

Swedish Council for Working Life and Social Research (Sweden) (Grant number: 2010-0024)

Alternative name(s)

Swedish Council for Working Life and Social Research, FAS

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Sweden

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23113955

Publication citations

  1. Results

    Bendtsen P, McCambridge J, Bendtsen M, Karlsson N, Nilsen P, Effectiveness of a proactive mail-based alcohol Internet intervention for university students: dismantling the assessment and feedback components in a randomized controlled trial., J. Med. Internet Res., 2012, 14, 5, e142, doi: 10.2196/jmir.2062.

Additional files

Editorial Notes

06/10/2016: Plain English summary added.