Plain English Summary
Background and study aims
The e-health portal on alcohol and health of the World Health Organization was launched on December 6, 2012. So far there are adapted versions in four countries and four different languages (https://www.infoalcohol.net/, https://www.informalcool.org.br, https://www.alcoholwebindia.in, https://www.saberdealcohol.org.mx/). This portal provides information for policymakers, professionals and the public at large on alcohol and health. It also includes a web-based self-help program to reduce alcohol consumption. Testing the effectiveness of this self-help program is the first step to open the program to other countries worldwide and make it more attractive for authorities in countries not yet involved. The potential public health impact of the expansion of an effective Internet self-help program to many low-income and high-income countries worldwide is enormous. The aim of this study is to test the effectiveness of the web-based self-help program to reduce alcohol consumption.
Who can participate?
People aged between 18 and 75 who live in Brazil, India, Mexico or Belarus.
What does the study involve?
Participants are randomly allocated to one of two groups. One group is given access to the Alcohol e-Health program, while the other group receives general information on alcohol and health, and is given access to the Alcohol e-Health program after the end of the study.
What are the possible benefits and risks of participating?
Participants may learn to reduce or to abstain from alcohol use by participating in the six-week self-help program. According to the experience in former studies, there are no significant health risks in participating in this' study. However, in case participants experience acute alcohol withdrawal or other physical or mental symptoms, they are recommend to see a health professional.
Where is the study run from?
1. The Information and Training Centre of Belarusian Psychiatric Association (Belarus)
2. Universidade Federal de Juiz de Fora, Universidade Federal de Sao Paulo and Universidade Federal do Parana (Brazil)
3. National Drug Dependence Treatment Center (NDDTC) (India)
4. Insituto Nacional de Psiquiatría Ramón de la Fuente Muñiz (Mexico)
When is the study starting and how long is it expected to run for?
January 2016 to June 2017
Who is funding the study?
World Health Organization (Switzerland)
Who is the main contact?
Dr Michael Schaub
Trial website
Contact information
Type
Public
Primary contact
Dr Michael P Schaub
ORCID ID
http://orcid.org/0000-0002-8375-4005
Contact details
Swiss Research Institute for Public Health and Addiction
Konradstrasse 32
Zürich
8031
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Alcohol e-Help – a web-based self-help program for the reduction of alcohol use in harmful, hazardous or suggestive dependent drinkers compared to an active waiting list: a cluster randomized controlled four-country trial
Acronym
Study hypothesis
The study hypothesizes that participants in the Alcohol e-Health program will show greater reductions in the Alcohol Use Disorders Identification Test score (AUDIT, primary outcome, Babor et al. 2001) at the 6-month follow-up than participants allocated to a waiting list control group. Similar hypotheses are drawn regarding secondary outcomes, the quantity of alcohol measured in weekly standard drinks and the number of alcohol abstinent days of a typical week in the last 6 months. Participants in the program group are also expected to be less harmful or hazardous drinkers (falling below the cut-off of 8 according to the AUDIT score, Babor et al. 2001) at the 6-month follow-up.
Ethics approval
1. WHO Ethics Review Committee, 30/06/2015, ref: RPC756
2. Four relevant country-specific ethics committees in Belarus, Brazil, India, and Mexico
Study design
Cluster randomized controlled four-country intervention trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Internet
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Harmful, hazardous or suggestive dependent alcohol users
Intervention
The randomization occurs on the individual level but for each country separately. Participants are randomized to either:
1. The Alcohol e-Health program
2. Classical waiting list receiving first general information on alcohol and health and program access only after 6 months
The Alcohol e-Health program is an accessible self-help tool for people who are trying to reduce their use of alcohol or stop drinking entirely. Participants can register and use the program in their own time, at their own pace, and free of charge. Participants are encouraged to complete all parts of the program, to repeat any parts they feel they need or perceive as helpful, and to use the program for a minimum of 6 weeks. Alcohol e-Health provides support for individual participants to think about their drinking, decide whether or not to change their drinking, set goals regarding their drinking, take action regarding reducing or stopping drinking, measure their progress, and to deal with relapse to their previous drinking patterns.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The total score of the Alcohol Use Disorders Identification Test (AUDIT, Babor et al. 2001) will be assessed at baseline and the 6-month follow-up
Secondary outcome measures
1. Falling below the cut-off of hazardous or harmful alcohol use (below AUDIT score of 8) between baseline and the 6-month follow-up
2. The alcohol use reflected for each weekday of a typical week in the last six months assessed at baseline and the 6-month follow-up
3. Program satisfaction is measured by the Client Satisfaction Questionnaire CSQ-8 assessed at the 6-months follow-up in the intervention group only
Overall trial start date
04/01/2016
Overall trial end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 75 years
2. To be a resident of one of the participating pilot countries
3. To have at least weekly Internet access
4. To have an AUDIT score ≥ 8
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
640
Participant exclusion criteria
1. Current substance abuse treatment
2. Use of opioids, inhalants, cocaine/crack or amphetamine/amphetamine-like stimulants, sedatives during the last month
3. Cannabis or synthetic cannabinoids for more than 4 days during the last month
Recruitment start date
01/09/2016
Recruitment end date
01/03/2017
Locations
Countries of recruitment
Belarus, Brazil, India, Mexico
Trial participating centre
The Information and Training Centre of Belarusian Psychiatric Association
Republican Mental Health Research and Practice Centre
987654321
Belarus
Trial participating centre
Associação Fundo de Incentivo à Pesquisa
Universidade Federal de Juiz de Fora, Universidade Federal de Sao Paulo and Universidade Federal do Parana
Rua Botucatu, 862 - 1º andar - Edifício de Ciências Biomédicas
Vila Clementino
São Paulo, SP
04023062
Brazil
Trial participating centre
National Drug Dependence Treatment Center (NDDTC)
All India Institute of Medical Sciences
Kamla Nehru Nagar
Ghaziabad
Uttar Pradesh
201002
India
Trial participating centre
Insituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
Calzada Mexico Xochimilco #101
Tlalpan
Huipulco
Ciudad de México, D.F.
14370
Mexico
Sponsor information
Organisation
World Health Organization (Switzerland)
Sponsor details
Management of Substance Abuse
Department of Mental Health and Substance Abuse
20 Avenue Appia
Geneva
1211
Switzerland
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
World Health Organization
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
Results and Publications
Publication and dissemination plan
There will be a study protocol publication and a publication on the overall study outcomes. The involved countries are recommended to publish further study outcome papers based on their data in their respective languages.
Intention to publish date
28/02/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28921778 (added 19/09/2019)