Alcohol e-Help self-help intervention
| ISRCTN | ISRCTN14037475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14037475 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/11/2015
- Registration date
- 13/11/2015
- Last edited
- 30/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
Swiss Research Institute for Public Health and Addiction
Konradstrasse 32
Zürich
8031
Switzerland
 ORCID ID |
0000-0002-8375-4005 |
|---|
Study information
| Study design | Cluster randomized controlled four-country intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 1. WHO Ethics Review Committee, 30/06/2015, ref: RPC756 2. Four relevant country-specific ethics committees in Belarus, Brazil, India, and Mexico |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 04/01/2016 |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 640 |
| Total final enrolment | 1400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 01/03/2017 |
Locations
Countries of recruitment
- Belarus
- Brazil
- India
- Mexico
Study participating centres
987654321
Belarus
Rua Botucatu, 862 - 1º andar - Edifício de Ciências Biomédicas
Vila Clementino
São Paulo, SP
04023062
Brazil
Kamla Nehru Nagar
Ghaziabad
Uttar Pradesh
201002
India
Tlalpan
Huipulco
Ciudad de México, D.F.
14370
Mexico
Sponsor information
Other
Management of Substance Abuse
Department of Mental Health and Substance Abuse
20 Avenue Appia
Geneva
1211
Switzerland
| Website | http://www.who.int/substance_abuse/activities/ehealth/en/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Other
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 28/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/02/2018 | 19/09/2019 | Yes | No |
| Results article | 27/08/2021 | 31/08/2021 | Yes | No | |
| Abstract results | 26/09/2019 | 30/11/2022 | No | No | |
| Abstract results | 29/06/2022 | 30/11/2022 | No | No |
Editorial Notes
30/11/2022: Publication references added.
31/08/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
19/09/2019: The following changes were made:
1. Publication reference added.
2. The intention to publish date was added.
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.
