Alcohol ConsumptionWIRUSNCT03466541
Workplace Interventions Preventing Risky Use of Alcohol and Sick Leave
A study testing Riskbruk and Balance in people with Alcohol Consumption and Sick Leave, run by University of Stavanger at 1 site in Norway.
Trial summary
The aim of this study is to investigate the effectiveness of two workplace interventions (the Riskbruk model and Balance) in reducing risky alcohol consumption, sickness absence and presenteeism. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Sick Leave, Workplace Interventions
- What is being tested?
- Riskbruk and Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employees screening positive for at-risk drinking (8+ on the AUDIT)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effectiveness of two workplace interventions (the Riskbruk model and Balance) in reducing risky alcohol consumption, sickness absence and presenteeism. The purpose is to assess whether the Riskbruk model should be implemented in the Norwegian workforce in its entirety, whether the less extensive and costly alternative Balance is sufficient, or if neither one of them show effectiveness compared to usual care.
- Conditions
- Alcohol Consumption, Sick Leave, Workplace Interventions, Presenteeism
- Being tested
- Riskbruk, Balance
- Keywords
- Alcohol consumption, Sick leave, Workplace interventions, Presenteeism
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiskbrukBehavioural
The Riskbruk model incorporates alcohol screening through a widely employed alcohol screening questionnaire, the Alcohol Use Disorders Identification Test (AUDIT) and a standard alcohol biomarker, carbohydrate-deficient transferring in serum (CDT), with brief consultations using the motivational interviewing (MI) technique. MI is a collaborative conversation style used to increase awareness and reflection around one's own drinking habits, as well as strengthening the person's motivation for a lifestyle change. The conversation style includes expressing empathy through reflective listening, communicating respect and acceptance of the participants and their feelings, and open up for self-reflection and exploration around the drinking behaviour.
BalanceBehavioural
Balance is a new Norwegian eHealth programme, and incorporates two approaches to behaviour modification interventions: a brief interventions and an intensive self-help programme. The intervention is based on cognitive-behavioural and self-help principles, and is given to the participants through multiple interactive sessions.
| Study group | Role | What they receive |
|---|---|---|
| Riskbruk | Experimental | The employees randomised to the Riskbruk group will be offered two consultations a ∼15 min with the OHS. The subjects will receive individual feedback on the screening results. During these sessions, Motivational Interviewing will be used. Receives: Behavioral: Riskbruk |
| Balance | Experimental | The group allocated to the Balance intervention will follow a comprehensive multi-session eHealth intervention with personalised feedback on the screening results. Receives: Behavioral: Balance |
| Control group/usual care | No intervention | The control group will receive the usual follow-up provided by the OHS for persons with risky alcohol behaviour. In order to provide something that appears as a plausible follow-up to the control participants, they will be given a booklet that covers general information about alcohol and potential risks and harms of drinking. The booklet contains no advise on how to achieve a change in drinking behaviour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol consumption
Measured: Baseline and 6 months
Change in sickness absence
Measured: Baseline and 6 months
Secondary outcomes (1)
Change in presenteeism
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study startAug 2013
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stavanger
- Sponsor type
- University, hospital or other
- Collaborators
- Kompetansesenter rus - region vest Stavanger (KoRus), Stamina Helse, Presenter, University of Oslo, Oslo Metropolitan University, Alcohol and Drug Research Western Norway (KoRFor), Norwegian Institute of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466541
- Sponsor's protocol ID
- AA0000
- Acronym
- WIRUS
- Status last verified
- Nov 2022
- First submitted
- 8 Mar 2018
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workplace Interventions Preventing Risky Use of Alcohol and Sick Leave
- ClinicalTrials.gov ID
- NCT03466541
- Acronym / sponsor ID
- WIRUS / AA0000
- Conditions
- Alcohol Consumption, Sick Leave, Workplace Interventions, Presenteeism
- Keywords
- Alcohol consumption, Sick leave, Workplace interventions, Presenteeism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of StavangerUniversity, hospital or other
- Collaborators
- Kompetansesenter rus - region vest Stavanger (KoRus), Stamina Helse, Presenter, University of Oslo, Oslo Metropolitan University, Alcohol and Drug Research Western Norway (KoRFor), Norwegian Institute of Public Health
- Study start
- Aug 2013
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effectiveness of two workplace interventions (the Riskbruk model and Balance) in reducing risky alcohol consumption, sickness absence and presenteeism. The purpose is to assess whether the Riskbruk model should be implemented in the Norwegian workforce in its entirety, whether the less extensive and costly alternative Balance is sufficient, or if neither one of them show effectiveness compared to usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Riskbruk | Experimental | Behavioral: RiskbrukThe employees randomised to the Riskbruk group will be offered two consultations a ∼15 min with the OHS. The subjects will receive individual feedback on the screening results. During these sessions, Motivational Interviewing will be used. |
| Balance | Experimental | Behavioral: BalanceThe group allocated to the Balance intervention will follow a comprehensive multi-session eHealth intervention with personalised feedback on the screening results. |
| Control group/usual care | No intervention | –The control group will receive the usual follow-up provided by the OHS for persons with risky alcohol behaviour. In order to provide something that appears as a plausible follow-up to the control participants, they will be given a booklet that covers general information about alcohol and potential risks and harms of drinking. The booklet contains no advise on how to achieve a change in drinking behaviour. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Employees screening positive for at-risk drinking (8+ on the AUDIT)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiskbrukThe Riskbruk model incorporates alcohol screening through a widely employed alcohol screening questionnaire, the Alcohol Use Disorders Identification Test (AUDIT) and a standard alcohol biomarker, carbohydrate-deficient transferring in serum (CDT), with brief consultations using the motivational interviewing (MI) technique. MI is a collaborative conversation style used to increase awareness and reflection around one's own drinking habits, as well as strengthening the person's motivation for a lifestyle change. The conversation style includes expressing empathy through reflective listening, communicating respect and acceptance of the participants and their feelings, and open up for self-reflection and exploration around the drinking behaviour. | Behavioural | Riskbruk |
| BalanceBalance is a new Norwegian eHealth programme, and incorporates two approaches to behaviour modification interventions: a brief interventions and an intensive self-help programme. The intervention is based on cognitive-behavioural and self-help principles, and is given to the participants through multiple interactive sessions. | Behavioural | Balance |
Primary outcome
Change in alcohol consumption
Time frame: Baseline and 6 months
Change in sickness absence
Time frame: Baseline and 6 months
1 secondary outcome
Change in presenteeism
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Riskbruk and Balance in people with Alcohol Consumption and Sick Leave, run by University of Stavanger at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alcohol consumption (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.