Condition category
Mental and Behavioural Disorders
Date applied
12/11/2015
Date assigned
13/11/2015
Last edited
01/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Please refer to the Plain English Summary field above

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 measures

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

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

http://www.who.int/substance_abuse/activities/ehealth/en/

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

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/09/2016: the following changes were made to the trial record: 1. The recruitment start date was changed from 04/01/2016 to 01/09/2016. 2. The recruitment end date was changed from 31/12/2016 to 01/03/2017.