Plain English Summary
Background and study aims
Drinking harmful amounts of alcohol can damage a person’s health and can lead to both social and economic costs. The Swedish National Alcohol Helpline provides telephone counselling to people that indulge in harmful and hazardous drinking who wish to change their drinking habits. The main aim of this study is to compare the effect of the current telephone counselling provided by the helpline, based on Motivational Interviewing techniques (treatment as usual), with a treatment based on self-help material and proactive follow-up counselling.
Who can participate?
Adults (aged at least 18) calling the Swedish National Alcohol Helpline for the first time in order to receive support to change their alcohol drinking habits
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 receive counselling currently offered by the Swedish National Alcohol Helpline (treatment as usual). The counselling is delivered according to each participants preference and involves Motivational interviewing and Cognitive Behavioural Therapy. Participants in group 2 are given a self-help booklet with information and exercises to help them change their alcohol drinking habits, followed by one session via telephone by a counsellor from the Helpline. All participants are assessed for their alcohol drinking habits and other health related statuses by telephone interview at the beginning of the study, as well as six and twelve months later.
What are the possible benefits and risks of participating?
Changes in alcohol drinking habits is very likely to lead to improvements in health and well-being. There is no risk of direct physical harm to participating in this study.
Where is the study run from?
Department of Public Health Sciences, Karolinska Institutet (Sweden)
When is study starting and how long is it expected to run for?
October 2014 to December 2018
Who is funding the study?
1. Public Health Agency of Sweden
2. Stockholm County Council
Who is the main contact?
Prof. Maria Rosaria Galanti
Prof Maria Rosaria Galanti
Department of Public Health Sciences
A randomized controlled study comparing the effectiveness of two counselling models at the Swedish National Alcohol Helpline in promoting changes of drinking habits among persons with hazardous or harmful alcohol use.
Current hypothesis as of 10/05/2017:
An alternative, partly proactive counselling model complemented by self-help material is more effective than the current on-demand counselling model in promoting change in a client’s alcohol drinking habits, measured by shift to lower AUDIT risk levels 6 and 12 months after the initial contact.
An alternative, partly proactive counselling model complemented by self-help material is as effective as the current on-demand model in promoting change in a client's alcohol drinking habits, measured by AUDIT scores 6 and 12 months after the initial contact.
Ethical Review Board of Stockholm Region, 06/11/2014, ref: 2014/1732-31/5
Current study design as of 10/05/2017:
Single-centre superiority pragmatic randomized trial
Previous study design:
Single-centre non-inferiority pragmatic randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Available in Swedish at: http://alkohollinjen.se/om-alkohollinjen/studier-pa-alkohollinjen/pagaende-studie/
Hazardous and harmful alcohol use
Participants are randomly allocated to one of two treatments:
1. The Alcohol Helpline’s free-of-charge telephone service (treatment as usual) designed to provide support to persons whose alcohol-related problems are moderate to severe. The current counselling is based on Motivational Interviewing (MI) combined with elements of Cognitive Behaviour Therapy and is adapted to the severity of the problems and to the changes that the client is ready to adopt. In practice, the intervention for a specific individual may consist of a varying number of client-activated (reactive) and/or counsellor-activated (proactive) sessions according to the client’s preference.
2. The alternative counselling model which includes the delivery of self-help booklet followed by a proactive call where the Helpline counsellor monitors the client’s progress and use of the material. The material is designed as a guide to the change of alcohol use patterns.
Primary outcome measure
Change of alcohol drinking habits measured with AUDIT score. The outcome assessment will be done at 6 and 12 month follow-up for each participant in the trial. Since entry in the trial will be at different dates the follow-up will follow a staggered schedule.
Secondary outcome measures
1. Depression or anxiety disorder (GAD) measured through MINI
2. Number of days of sick leave
3. Care seeking from other services for alcohol problems
The outcome assessment will be done at 6 and 12 month follow-up for each participant in the trial. Since entry in the trial will be at different dates the follow-up will follow a staggered schedule.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. First time caller of the National Alcohol Helpline
2. Seeking support to change his/her own alcohol drinking habits
3. At least 18 years of age
4. Provide informed consent
Target number of participants
Participant exclusion criteria
1. Very severe alcohol problems requiring clinical treatment
2. Abuse of other drugs
3. Severe mental illness
4. Acute health problems
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Centre for Epidemtiology and Community Medicine, Stockholm County Council
Department of Public Health Sciences, Karolinska Institutet
Centre for Epidemiology and Community Medicine, Stockholm County Council
Public Health Authority of Sweden
Funding Body Type
Funding Body Subtype
Stockholms Läns Landsting
Stockholm County Council
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28587621