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
rosaria.galanti@ki.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Maria Rosaria Galanti
ORCID ID
http://orcid.org/0000-0002-7805-280X
Contact details
Department of Public Health Sciences
Karolinska Institutet
Stockholm
17177
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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.
Acronym
AlC_HL
Study hypothesis
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.
Previous hypothesis:
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.
Ethics approval
Ethical Review Board of Stockholm Region, 06/11/2014, ref: 2014/1732-31/5
Study design
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Available in Swedish at: http://alkohollinjen.se/om-alkohollinjen/studier-pa-alkohollinjen/pagaende-studie/
Condition
Hazardous and harmful alcohol use
Intervention
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.
Intervention type
Behavioural
Phase
Drug names
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
01/10/2014
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
300
Total final enrolment
261
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
27/05/2015
Recruitment end date
31/12/2017
Locations
Countries of recruitment
Sweden
Trial participating centre
Centre for Epidemtiology and Community Medicine, Stockholm County Council
Tomtebodavägen 18a
Stockholm
17177
Sweden
Sponsor information
Organisation
Karolinska Institute
Sponsor details
Department of Public Health Sciences
Tomtebodavägen 18a
Stockholm
17177
Sweden
Sponsor type
University/education
Website
Organisation
Centre for Epidemiology and Community Medicine, Stockholm County Council
Sponsor details
Tomtebodavägen 18a
Stockholm
17177
Sweden
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Public Health Authority of Sweden
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stockholms Läns Landsting
Alternative name(s)
Stockholm County Council
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Results and Publications
Publication and dissemination plan
Intention to publish date
31/03/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28587621
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31286906 (added 18/03/2020)