- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01931618
Testing the Efficacy of an Online Alcohol Intervention in a Workplace Setting
Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".
The purpose of this study is to test - in a workplace setting - if an online multi-session alcohol intervention improves treatment effect over and above a single session screening with feedback.
Hypothesis: automated online multi-session follow-up improves the effect on alcohol consumption over and above a single session screening
Study Overview
Status
Conditions
Detailed Description
Setting: Online study among Norwegian employees.
Participants: At-risk drinkers among employees in a select group of norwegian workplaces is recruited through an e-mail to their job e-mail account, and advertisements on the intranet of their organization.
Design: Randomized controlled trial (RCT). Subjects in both conditions receives a single session screening procedure including individualized normative feedback. The control group receives an online booklet about the effects of alcohol. The treatment group receives the multi session follow up program "Balance".
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway
- The Norwegian Centre for Addiction Research, University of Oslo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- hazardous or harmful drinking (i.e., a FAST-score of 3 or more)
Exclusion Criteria:
- underage (<18)
- not provided a valid e-mail address
- not provided a valid (Norwegian) mobile phone number
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
Receives two interventions:
|
An online single session screening procedure including individualized normative feedback.
An online booklet that covers general information about alcohol, its effect on the brain and the body, potential risks and harms of drinking, and an account of the threshold values of sensible drinking
|
Experimental: Extended follow-up
Receives two interventions:
|
An online single session screening procedure including individualized normative feedback.
An online multi session follow-up program (i.e., "Balance").
The central concept of Balance is to support continued self-regulation throughout the behavior change process.
There are four key aspects of the program, the first is focus on goal setting and tracking of alcohol consumption on a day-to-day basis.
The second on relapse prevention - for example, when clients report drinking more than their target, they receive individualized content aimed at preventing a full blown relapse.
The third is emotion regulation, where content and assignments from positive psychology and from cognitive behavioral therapy are used.
Finally, intervention covers alcohol education (i.e. the same topics as in the booklet provided to the control group).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of standard alcohol units consumed during the previous seven days
Time Frame: Measured six months after enrollment/baseline
|
Subjects are asked to indicate (through online questionnaires) how many standard alcohol units they consumed on each of the previous seven days, on a scale from zero to ten.
Then a sum-score for weekly consumption is calculated, ranging from zero to 70.
|
Measured six months after enrollment/baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sick leave during last week
Time Frame: Assessed at six months post baseline
|
Sick leave was assessed with a "yes" or "no" response for each of the past seven days, and then accumulated, resulting in a score of zero to seven.
Participants were instructed to report any sick leave regardless of reason.
|
Assessed at six months post baseline
|
Negative consequences of alcohol consumption
Time Frame: Assessed at six months post baseline
|
Perceived negative consequences of own alcohol consumption, during the seven previous days, was assessed by a 13 item index, resulting in a sum score with a theoretical range from zero to 13.
The items comprised: headache, nausea, anxiety, worn out, depressed, breaking a plan, breaking a date, sick leave, memory problems, bad conscience, conflict, destroyed something and injuries.
|
Assessed at six months post baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Håvar Brendryen, PhD, The Norwegian Centre for Addiction Research, University of Oslo
Publications and helpful links
General Publications
- Brendryen H, Johansen A, Nesvag S, Kok G, Duckert F. Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach. JMIR Res Protoc. 2013 Jan 23;2(1):e6. doi: 10.2196/resprot.2371.
- Brendryen H, Johansen A, Duckert F, Nesvag S. A Pilot Randomized Controlled Trial of an Internet-Based Alcohol Intervention in a Workplace Setting. Int J Behav Med. 2017 Oct;24(5):768-777. doi: 10.1007/s12529-017-9665-0.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SERAF-BALANCE-2
- 142956 (Other Grant/Funding Number: Norwegian Centre for Addiction Research, University of Oslo)
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.
Clinical Trials on Hazardous Drinking
-
University of OsloThe Research Council of NorwayCompleted
-
University Medicine GreifswaldGerman Cancer AidCompletedHazardous DrinkingGermany
-
UConn HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
University Medicine GreifswaldGerman Research FoundationCompleted
-
Brown UniversityCompletedCigarette Smoking | Hazardous DrinkingUnited States
-
Centre for Addiction and Mental HealthCanadian Institutes of Health Research (CIHR)CompletedAlcohol Consumption | Hazardous Alcohol ConsumptionCanada
-
Institut national de prevention et d'education...CompletedHazardous Alcohol Consumption
-
Hospital Clinic of BarcelonaUniversity College, London; Fundacion Clinic per a la Recerca Biomédica; Instituto... and other collaboratorsCompleted
-
Brown UniversityCompletedHIV | Hazardous DrinkingUnited States
-
Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedHazardous Drinking | Harmful DrinkingUnited States
Clinical Trials on Online screening and feedback
-
University of OsloThe Research Council of NorwayCompleted
-
María Rodríguez BailónUniversidad de GranadaCompletedExecutive Dysfunction | Anosognosia | Brain DamageSpain
-
Public Health Service of AmsterdamCompleted
-
CHU de Quebec-Universite LavalLaval University; Genome Canada; Genome Quebec; CERSSPLCompletedShared Decision MakingCanada
-
Universitätsklinikum Hamburg-EppendorfGerman Research FoundationCompletedDepression | Major Depressive DisorderGermany
-
University of MichiganNational Institute for Occupational Safety and Health (NIOSH/CDC)CompletedOccupational Health | Hazardous Material Handling
-
McMaster UniversityCanadian Institutes of Health Research (CIHR)CompletedMedical and Nursing Students' Evidence Retrieval SkillsCanada
-
McMaster UniversityCanadian Institutes of Health Research (CIHR)CompletedPhysicians Evidence Retrieval SkillsCanada
-
Unity Health TorontoCompletedSocial Determinants of Health | Social Isolation | Poverty | Social MarginalizationCanada
-
Seoul National University HospitalRecruitingCardiopulmonary Resuscitation | EducationKorea, Republic of