- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03466541
Workplace Interventions Preventing Risky Use of Alcohol and Sick Leave (WIRUS)
November 22, 2022 updated by: University of Stavanger
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 Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rogaland
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Stavanger, Rogaland, Norway, 4021
- University of Stavanger
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Employees screening positive for at-risk drinking (8+ on the AUDIT)
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Riskbruk
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.
|
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.
|
EXPERIMENTAL: Balance
The group allocated to the Balance intervention will follow a comprehensive multi-session eHealth intervention with personalised feedback on the screening results.
|
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.
|
NO_INTERVENTION: Control group/usual care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in alcohol consumption
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Change in sickness absence
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in presenteeism
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (ANTICIPATED)
December 31, 2025
Study Completion (ANTICIPATED)
December 31, 2025
Study Registration Dates
First Submitted
March 8, 2018
First Submitted That Met QC Criteria
March 8, 2018
First Posted (ACTUAL)
March 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 28, 2022
Last Update Submitted That Met QC Criteria
November 22, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA0000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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