Condition category
Mental and Behavioural Disorders
Date applied
25/03/2011
Date assigned
08/04/2011
Last edited
21/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Marc-Dennan Tensil

ORCID ID

Contact details

Delphi GmbH
Kaiserdamm 8
Berlin
14057
Germany
tensil@delphi-gesellschaft.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparing the efficacy of two web-based self-help interventions for young adults with risky alcohol use – a randomised controlled trial

Acronym

Study hypothesis

The modified program with more computer-tailored feedbacks and interactive elements of relapse prevention is more effective than the original version

Ethics approval

The ethics committee of the University of Applied Sciences Magdeburg-Stendal approved the study protocol an 28/10/2010 (ref: AZ 4973-15)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Patient information in German can be found at : ghttps://www.drugcom.de/changeyourdrinking_studieninfo.pdf (german)

Condition

Risky alcohol use, alcohol abuse or addiction

Intervention

1. Two versions of a fully automated self-help intervention for adolescents and young adults with risky alcohol use are compared
2. Both versions of “change your drinking” begin with a self-test (“check your drinking”), which gives a personalised feedback
3. The aim of “change your drinking” is to reduce or to drinking
4. In detail, participants should not drink more than 24g/12g (m/f) pure alcohol per day
5. They can even choose to drink less or abstain from drinking
6. After registration participants get access to a drinking diary
7. In the original program the drinking dairy can be filled out for 10 days and participants receive a short personalised feedback at the end
8. The modified version lasts 14 days and consists of additional interactive elements:
8.1. Participants receive short personalised feedbacks every day and longer feedbacks 7 and 14 days after registration
8.2. Every day participants are advised to reflect their personal risk situations and to develop strategies in order to cope with those situations (relapse prevention)
8.3. Participants are encouraged to reward themselves for achieving their personal goal
8.4. The drinking diary can be extended for additional 14 days, but without personalised feedback
9. The program is open to the general public
10. Eligibility criteria will be checked after completion of the self-test “check your drinking” 11. Users who do not meet criteria or do not want to participate on the study receive the original version of “change your drinking”

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Alcohol consumption within the last seven days: amount of pure alcohol
2. Mean number of drinking days in the past 30 days
3. Proportion of subjects drinking within the guidelines: i.e., not drinking more than 24 grams of pure alcohol (men) or 12 grams (women) on any day during the last week
4. Proportion of binge drinking within the last seven days: five or more drinks on one occasion
5. Mean number of alcohol related problems
6. Follow-ups are carried out six weeks and three months after registration

Secondary outcome measures

Satisfaction with the intervention

Overall trial start date

01/03/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Minimum age of 18 years
2. Alcohol Use Disorder Identification Test (AUDIT): score of 8 or more
3. Last week average daily alcohol consumption of pure alcohol: 24g (males), 12g (females)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

624

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Delphi GmbH
Berlin
14057
Germany

Sponsor information

Organisation

Federal Centre for Health Education (BZgA) (Germany)

Sponsor details

Ostmerheimer Str. 220
Köln
51109
Germany

Sponsor type

Government

Website

http://www.bzga.de

Funders

Funder type

Government

Funder name

Federal Centre for Health Education (BZgA) (Germany)

Alternative name(s)

Federal Centre for Health Education, BZgA

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23742808

Publication citations

  1. Results

    Tensil MD, Jonas B, Strüber E, Two fully automated web-based interventions for risky alcohol use: randomized controlled trial., J. Med. Internet Res., 2013, 15, 6, e110, doi: 10.2196/jmir.2489.

Additional files

Editorial Notes