Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Misuse of alcohol and alcohol dependence are a growing problem worldwide. Many people show signs of drinking too much alcohol, or drinking alcohol at inappropriate times (hazardous alcohol use), and are at risk of developing alcohol dependence, often known as “alcoholism”. It is thought that the best way of preventing alcohol dependence is to better educate people who are at risk of developing it. Providing an inexpensive self-help programme using the internet to prevent people from developing full alcohol-dependence could be very beneficial from a public health point of view. The aim of this study is find out whether the use of a web-based self-help programme for hazardous alcohol users can help to reduce alcohol intake.

Who can participate?
Adults who are hazardous alcohol users but not clinically depressed.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in the first group (intervention group) are started on a 6 week self-help programme focusing on alcohol use via the internet. This programme provides education materials as well as teaching self-control practices and techniques to reduce cravings. The participants are asked to keep a diary throughout the 6 week intervention, in order to study their thoughts on the programme and see how well the treatment is working. Those in the second group (control group) are put on a waiting list. After 6 months on the waiting list, those in the control group are given the opportunity to start the online self-help programme. For both groups, at the start of the study, at three months and at six months, alcohol consumption is measured, as well as mental health issues (such as depression). The cost-effectiveness of the programme is also measured at these time points.

What are the possible benefits and risks of participating?
Benefits of participating include a better understanding of addictive behaviour and being given tools to help handle cravings and reducing the risk of alcohol dependency. Potential risks of participating are insignificant, however withdrawal symptoms, such as cravings, may be experienced.

Where is the study run from?
1. Swiss Research Institute for Public Health and Addiction (Switzerland)
2. Leuphana University (Germany)
3. Arkin Mental Health Care (Netherlands)
4. Amsterdam Institute for Addiction Research (Netherlands)
5. VU University of Amsterdam (Netherlands)

When is the study starting and how long is it expected to run for?
November 2015 to January 2018

Who is funding the study?
Swiss Foundation for Alcohol Research (Switzerland)

Who is the main contact?
Dr Michael Schaub

Trial website

Contact information



Primary contact

Dr Michael Schaub


Contact details

Konradstrasse 32
CH-8031 Zurich

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Web-based Treatment Trial among Problematic Alcohol Users


Study hypothesis

Tailored self-help for the reduction of alcohol use is more effective than the waiting list control condition in reducing alcohol use between the baseline and the 3 and 6 months follow-ups.

Ethics approval

Ethics Committee of the Canton of Zurich, 01/09/205, ref: KEK-ZH-Nr: 2015-0082

Study design

Randomised contolled trial with web-based psychological intervention

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Harmful or hazardous alcohol use


After ensuring that potential participants are eligible for the study (i.e., after a baseline assessment), they will be randomized by a computer program to 1 of 2 parallel groups:

1. Experimental intervention: web-based self-help program focusing on alcohol; and
2. Control condition: waiting list.

The web-based self-help intervention (study arm 1) consist of a diary (assesses daily alcohol consumption) and several (currently 8) modules based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioural therapy. Participants can study all modules at their own pace and in their own order, though a specific order will be advised. This web-based self-help intervention consist of a 6-week program starting individually at the point of the user's online registration. Follow-ups will be assessed 3 and 6 month after the individual’s self-chosen starting point. The control condition is a waiting-list. The follow-ups are timed as in the experimental intervention (after 3 and 6 months). After 6 months the study phase of the control condition is finished and people will be given the opportunity to start the self-help programme of the experimental condition.

Intervention type



Drug names

Primary outcome measures

The number of weekly standard drinks will be assessed with timeline follow-back (TLFB) at baseline, 3 months and 6 months.

Secondary outcome measures

1. Depressive symptoms assessed with the "Center of Epidemiologic Studies of Depression" (CES-D-20) at baseline, 3 months and 6 months
2. Use of tobacco and illicit drugs assessed with the "Fragebogen Substanzanamnese" questionnaire (FDA) at baseline, 3 months and 6 months
3. Changes in mental health symptoms assessed with the Mental Health Inventory questionnaire (MHI-5) at baseline, 3 months and 6 months
4. Treatment retention measured by using the diary every week over the 6-weeks of intervention
5. Cost-effectiveness-analyses assessed with the EuroQol Quality of Life questionnaire (EQ-5D-3L) at baseline, 3 months and 6 months
6. Cost-utility-analysis and client intervention satisfaction assessed with the Questionnaire on healthcare utilization and productivity losses (TiC-P) at baseline, 3 months and 6 months
7. The "Customer Satisfaction Questionnaire" (CSQ-8) is used as secondary outcome only for participants who have received web-based self-help intervention for 6 weeks (i.e., not used for the control group) measured every week over the 6-weeks of intervention
8. Drinking behaviour is determined using the total score of the short version of the Alcohol Use Disorders Identification Test (AUDIT-C) at baseline, 3 months and 6 months

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged 18 years or over
2. AUDIT score ≥ 8 and ≤ 20 (AUDIT = Alcohol Use Disorder Inventory Test)
3. CES-D-20 score < 16 (Center of Epidemiological Studies of Depression)
4. Weekly Internet access

Participant type


Age group




Target number of participants

520 (2 groups of 260)

Participant exclusion criteria

1. Participation in other psycho-social or pharmacological treatments for the reduction/cessation of alcohol use or the reduction of depression symptoms
2. Use of opioids or stimulants in the last 12 months and/or cannabis use of more than once a week in the previous 30 days
3. Previous treatment for cardiovascular problems
4. Suicidal thoughts or plans in the last 12 months
5. Pregnancy or breast feeding in female participants

Recruitment start date


Recruitment end date



Countries of recruitment

Germany, Netherlands, Switzerland

Trial participating centre

Swiss Research Institute for Public Health and Addiction
Konradstrasse 32

Trial participating centre

Leuphana University
Scharnhorststraße 1

Trial participating centre

Arkin Mental Health Care
Klaprozenweg 111

Trial participating centre

Amsterdam Institute for Addiction Research
Meibergdreef 5

Trial participating centre

VU University of Amsterdam
De Boelelaan 1105

Sponsor information


Swiss Foundation for Alcohol Research

Sponsor details

Elisabeth Domenge-Vieu
P.O.Box 870

Sponsor type




Funder type

Research organisation

Funder name

Swiss Foundation for Alcohol Research

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 01/12/2015, the original primary outcome measure (Drinking behaviour is determined using the total score of the short version of the Alcohol Use Disorders Identification Test (AUDIT-C) at baseline, 3 months and 6 months) has been changed to a secondary outcome measure. A new primary outcome measure has been added to the record.