Condition category
Mental and Behavioural Disorders
Date applied
12/04/2019
Date assigned
04/06/2019
Last edited
04/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Misuse of alcohol is a worldwide problem that has a lot of negative consequences to public health. In 2017 alcohol consumption level reached over 10 litres of absolute alcohol per adult in Estonia. In resents years’ different activities directed towards the increase of people's skills and knowledge; empower of healthcare specialist; as well as legislative initiatives (taxation, limitations on alcohol beverages advertisements) were introduced in Estonia. In this overall prevention package, a cost-effective internet based self-help programme to prevent people from developing full alcohol-dependence was missing. Therefore, the programme Take Care of You (TCOY), that was developed and positively tested in Switzerland was adapted and translated into Estonian.
The aim of this study is find out whether the use of the web-based self-help programme TCOY for harmful and hazardous alcohol users can help to reduce alcohol intake in Estonians.

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

What does the study involve?
Participants are randomly allocated into one of two groups. Those in the first group (intervention group) are started on an 8-weeks 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 8- weeks 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 two months and at six months, alcohol consumption is measured, as well as mental health issues.
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.Estonian National Institute for Health Development (Estonia)
2. Swiss Research Institute for Public Health and Addiction (Switzerland)

When is the study starting and how long is it expected to run for?
June 2018 to December 2019

Who is funding the study?
European Social Fund and Estonian National Institute for Health Development
Who is the main contact?
Mrs Esta Kaal

Trial website

https://selge.alkoinfo.ee/?q=homepageguest

Contact information

Type

Scientific

Primary contact

Mrs Esta Kaal

ORCID ID

http://orcid.org/0000-0001-8872-2451

Contact details

Hiiu 42
Tallinn
11619
Estonia
+372 659 3900
esta.kaal@tai.ee

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Web-based treatment trial among hazardous alcohol users: a randomised controlled trial.

Acronym

N/A

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 2 and 6 months’ follow-ups.

Ethics approval

Approved 21/02/2019, Tallinn Medical Research Ethics Committee’s (Hiiu 42, Tallinn 11619; eetikakomitee@tai.ee; +372 659 3924; +372 659 3901), ref: 2637.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Harmful or hazardous alcohol use.

Intervention

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 10 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 an 8-week program starting individually at the point of the user's online registration. Follow-ups will be assessed 2 and 6 months 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 2 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 out of the experimental condition.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Alcohol consumption, drinking behaviors, and alcohol-related problems are measured using the Alcohol Use Disorders Identification Test (AUDIT) score at 6 months’ follow-up.

Secondary outcome measures

1. The number of standard drinks and alcohol-free days is measured using a self-report on typical week during the past 6-months.
2. Treatment retention is measured using the alcohol consumption diary every week over the 8-weeks of intervention.
3. The following is assessed at baseline, 2 months and 6 months:
3.1. Illicit drugs consumption is measured using the NIDA questionnaire.
3.2. Mental health symptoms is measured using the Mental Health Inventory questionnaire (MHI-5).
4. Motivation to drink and motivation to change are measured using the Drinking Motives Questionnaire (DMQ-R-5) and Motivation for Change Questionnaire (3 items) at baseline, 2 months and 6 months.
5. Satisfaction with the trial is measured using the "Customer Satisfaction Questionnaire" for internet interventions (iCSQ-8) in the intervention group at the end of the intervention.
6. Usage of other resources is measured in the control group at 2 months and 6 months.

Overall trial start date

21/06/2018

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. AUDIT score ≥ 8
3. Weekly Internet access
4. Able to read and understand Estonian language

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

600 (2 groups of 300)

Participant exclusion criteria

1. Participation in other psycho-social or pharmacological treatments for the reduction/cessation of alcohol, opioids, stimulants or cannabis
2. In the last 12 months use of opioids or stimulants or cannabis use of more than once a week in the previous 30 days
3. Previous treatment for cardiovascular problems
4. Pregnancy or breast feeding in female participants
5. Suicidal thoughts or plans in the last 24 months

Recruitment start date

13/04/2019

Recruitment end date

15/04/2019

Locations

Countries of recruitment

Estonia

Trial participating centre

Estonian National Institute for Health Development
Hiiu 42
Tallinn
11619
Estonia

Trial participating centre

Swiss Research Institute for Public Health and Addiction (ISGF)
Konradstrasse 32
Zurich
8005
Switzerland

Sponsor information

Organisation

Estonian National Institute for Health Development

Sponsor details

Hiiu 42
Tallinn
11619
Estonia
+372 659 3900
tai@tai.ee

Sponsor type

Research organisation

Website

https://www.tai.ee/en/

Funders

Funder type

Government

Funder name

European Social Fund

Alternative name(s)

Europäische Sozialfonds, Fondo Social Europeo, Fonds Social Européen, ESF

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Funder name

Estonian National Institute for Health Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal and study report for local use.

IPD sharing statement: the data sets generated during the current study will be available upon request from Mrs. Esta Kaal, esta.kaal@tai.ee via internet in the form of anonymised raw data set in CSV-format from 1.05.2021 to 1.05.2036. The informed consent was asked in the online form.

Intention to publish date

31/05/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/04/2019: Trial's existence confirmed by the Tallinn Medical Research Ethics Committee.