Condition category
Mental and Behavioural Disorders
Date applied
13/10/2011
Date assigned
04/11/2011
Last edited
11/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Because alcohol causes huge health problems for society in order to prevent and reduce problems we need to help people think about their drinking. This can be done online, asking people to complete a few questions and giving brief feedback and advice where it may be needed. This study aims to find out whether a brief online intervention 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?
Students from two universities in 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, comparing their drinking patterns against the safe drinking limits established by the Swedish Institute for Public Health. After this follows feedback describing their alcohol use compared to their peers in Swedish universities and, if applicable, personalised advice concerning the importance of reducing unhealthy levels or patterns of drinking. The feedback can be printed out by the student. 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 general health survey about students’ lifestyle habits with no reference to the previous surveys. All students at this time have an opportunity to receive personalised feedback.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Two universities in Sweden.

When is the study starting and how long is it expected to run for?
September to December 2011.

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
581 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

Alcohol eMail Assessment & feedback study Dismantling Effectiveness for University Students: the AMADEUS-1 trial

Acronym

AMADEUS-1

Study hypothesis

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 the assessment has an impact on drinking behaviour but to a lesser extent that the intervention.

Ethics approval

Regional Ethical Committe 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

Internet

Trial type

Quality of life

Patient information sheet

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

Condition

Risky alcohol consumption

Intervention

Intervention delivery begins with receipt of an e-mail with a hyperlink to a computerised alcohol intervention. The mail is send from the local student health care asking them to participate in a short 9 question survey concerning alcohol habits. They will be informed that the survey is part of the university´s work with alcohol in general. After having completed a 9 item questionnaire the intervention Group feedback immediately upon completion of the assessment consisting of three statements summarising their weekly consumption, their frequency of heavy episodic drinking and their highest blood alcohol concentration during the last four weeks, comparing drinking patterns against the safe drinking limits established by the Swedish Institute for Public Health. After this follows comprehensive normative feedback with information describing participants' alcohol use compared to their peers in Swedish universities, and, if applicable, personalised advice concerning the importance of reducing any unhealthy levels or pattern of consumption. The feedback can be printed out by the student. A demonstration version can be viewed of the assessment and feedback intervention can be viewed at demo.livsstilstest.nu.

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 no contact group that do not know they will be asked to complete a seemingly unrelated general health survey, including alcohol questions, after 3 months
2. An “assessment only” group that complete the baseline questionnaire without getting a feedback who also do not know they will be asked to complete a seemingly unrelated general health survey, including alcohol questions, after 3 month.

After 3 month all students in all three groups will receive a mail from the research group asking them to participate in a seemingly unrelated general health survey about students lifestyle habits with no reference to the previous survey 3 month earlier. This is done in order minimise a Hawthorne effect in the “assessment group” and the “assessment and feedback 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 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

Behavioural

Phase

Drug names

Primary outcome measures

1. Reduced average alcohol consumption
2. Reduced frequency of heavy episodic drinking
3. Reduced 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

Reduction in 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

01/09/2011

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

All university students at term 1, 3 and 5 in two universities in Sweden

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15,000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2011

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Sweden

Trial participating centre

Linköping University
Linköping
581 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

Government

Website

http://www.fas.se

Funders

Funder type

Government

Funder name

Swedish Council for Working Life and Social Research (Sweden) ref: 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 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22540638
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24072758

Publication citations

  1. Protocol

    McCambridge J, Bendtsen P, Bendtsen M, Nilsen P, Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1): study protocol for a randomized controlled trial., Trials, 2012, 13, 1, 49, doi: 10.1186/1745-6215-13-49.

  2. Results

    McCambridge J, Bendtsen M, Karlsson N, White IR, Nilsen P, Bendtsen P, Alcohol assessment and feedback by email for university students: main findings from a randomised controlled trial., Br J Psychiatry, 2013, 203, 5, 334-340, doi: 10.1192/bjp.bp.113.128660.

Additional files

Editorial Notes