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

ISRCTN	ISRCTN31586428
DOI	https://doi.org/10.1186/ISRCTN31586428
Protocol serial number	N/A
Sponsor	Federal Centre for Health Education (BZgA) (Germany)
Funder	Federal Centre for Health Education (BZgA) (Germany)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparing the efficacy of two web-based self-help interventions for young adults with risky alcohol use a randomised controlled trial
Study objectives	The 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) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Satisfaction with the intervention
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	624
Key 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)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/03/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Germany

Study participating centre

Delphi GmbH

Berlin
14057
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes