Evaluation of two web-based self-help interventions for young adults with risky alcohol use
ISRCTN | ISRCTN31586428 |
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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
Scientific
Delphi GmbH
Kaiserdamm 8
Berlin
14057
Germany
tensil@delphi-gesellschaft.de |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Prevention |
Participant information sheet | Patient information in German can be found at : ghttps://www.drugcom.de/changeyourdrinking_studieninfo.pdf (german) |
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 | 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 study start date | 01/03/2011 |
Completion date | 31/12/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
14057
Germany
Sponsor information
Federal Centre for Health Education (BZgA) (Germany)
Government
Government
Ostmerheimer Str. 220
Köln
51109
Germany
Website | http://www.bzga.de |
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https://ror.org/054c9y537 |
Funders
Funder type
Government
Federal Centre for Health Education (BZgA) (Germany)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Centre for Health Education, BZgA
- Location
- Germany
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 06/06/2013 | Yes | No |