Evaluation of two web-based self-help interventions for young adults with risky alcohol use

ISRCTN ISRCTN31586428
DOI https://doi.org/10.1186/ISRCTN31586428
Secondary identifying numbers N/A
Submission date
25/03/2011
Registration date
08/04/2011
Last edited
21/06/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Marc-Dennan Tensil
Scientific

Delphi GmbH
Kaiserdamm 8
Berlin
14057
Germany

Email tensil@delphi-gesellschaft.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Patient information in German can be found at : ghttps://www.drugcom.de/changeyourdrinking_studieninfo.pdf (german)
Scientific titleComparing the efficacy of two web-based self-help interventions for young adults with risky alcohol use – a randomised controlled trial
Study objectivesThe modified program with more computer-tailored feedbacks and interactive elements of relapse prevention is more effective than the original version
Ethics approval(s)The ethics committee of the University of Applied Sciences Magdeburg-Stendal approved the study protocol an 28/10/2010 (ref: AZ 4973-15)
Health condition(s) or problem(s) studiedRisky alcohol use, alcohol abuse or addiction
Intervention1. 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 typeOther
Primary outcome measure1. 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 measuresSatisfaction with the intervention
Overall study start date01/03/2011
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants624
Key inclusion criteria1. 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)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/03/2011
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • Germany

Study participating centre

Delphi GmbH
Berlin
14057
Germany

Sponsor information

Federal Centre for Health Education (BZgA) (Germany)
Government

Ostmerheimer Str. 220
Köln
51109
Germany

Website http://www.bzga.de
ROR logo "ROR" https://ror.org/054c9y537

Funders

Funder type

Government

Federal Centre for Health Education (BZgA) (Germany)
Government organisation / National government
Alternative name(s)
Federal Centre for Health Education, BZgA
Location
Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 06/06/2013 Yes No