Experimental evaluation of the Swedish National Alcohol Helpline
| ISRCTN | ISRCTN13160878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13160878 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/11/2015
- Registration date
- 18/01/2016
- Last edited
- 15/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Department of Public Health Sciences
Karolinska Institutet
Stockholm
17177
Sweden
 ORCID ID |
0000-0002-7805-280X |
|---|
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Available in Swedish at: http://alkohollinjen.se/om-alkohollinjen/studier-pa-alkohollinjen/pagaende-studie/ |
| 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. |
| Study acronym | AlC_HL |
| Study objectives | 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(s) | Ethical Review Board of Stockholm Region, 06/11/2014, ref: 2014/1732-31/5 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2014 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 261 |
| Key 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 |
| Key exclusion criteria | 1. Very severe alcohol problems requiring clinical treatment 2. Abuse of other drugs 3. Severe mental illness 4. Acute health problems |
| Date of first enrolment | 27/05/2015 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
17177
Sweden
Sponsor information
University/education
Department of Public Health Sciences
Tomtebodavägen 18a
Stockholm
17177
Sweden
| Website | http://www.ki.se |
|---|---|
"ROR" |
https://ror.org/056d84691 |
Government
Tomtebodavägen 18a
Stockholm
17177
Sweden
Funders
Funder type
Government
No information available
Government organisation / Local government
- Alternative name(s)
- Stockholm County Council
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/03/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/06/2017 | Yes | No | |
| Results article | results | 08/07/2019 | 18/03/2020 | Yes | No |
| Results article | 27/04/2021 | 15/02/2023 | Yes | No |
Editorial Notes
15/02/2023: Publication reference added.
18/03/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
22/01/2018: Internal review.
08/06/2017: Publication reference added.
10/05/2017: The target number of participants was updated from 886 to 300. The study hypothesis and study design were updated.
