Hazardous DrinkingNCT01754090
Testing the Efficacy of an Online Alcohol Intervention
A study testing Online screening and feedback, Online booklet. and Online multi session follow-up in people with Hazardous Drinking and Harmful Drinking, run by University of Oslo at 1 site in Norway.
Trial summary
The purpose of this study is to test whether an online multi session alcohol intervention improves treatment effect compared to single session screening with feedback only. All participants in the trial received a single session screening procedure including individualized normative feedback (usual care). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hazardous Drinking, Harmful Drinking
- What is being tested?
- Online screening and feedback, Online booklet. and Online multi session follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hazardous or harmful drinking (i.e., a FAST-score of 3 or more)
Who cannot join
- underage (<18)
- not provided a valid e-mail address
- not provided a valid (Norwegian) mobile phone number
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian Centre for Addiction Research, University of Oslo
Oslo, 0315
About this study
Official title: Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".
The purpose of this study is to test whether an online multi session alcohol intervention improves treatment effect compared to single session screening with feedback only.
All participants in the trial received a single session screening procedure including individualized normative feedback (usual care). Additionally, half of the participants received a simple online booklet about the effects of alcohol. The other half received an online multi session follow up program.
Read the detailed description
Aims: Test whether a multi session alcohol intervention improves treatment effect (i.e., reduced consumption of alcohol) compared to single session screening with feedback.
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" .
Setting: Online study in Norway. Participants: At-risk drinkers is recruited through internet advertisements and randomly assigned to one of two conditions.
- Conditions
- Hazardous Drinking, Harmful Drinking
- Being tested
- Online screening and feedback, Online booklet., Online multi session follow-up
- Keywords
- alcohol, online intervention, hazardous drinking, harmful drinking, early intervention, behavior change intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online screening and feedbackBehavioural
An online single session screening procedure including individualized normative feedback.
Online booklet.Behavioural
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
Online multi session follow-upBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Receives two interventions:
1. Online screening and feedback.
2. Online booklet. Receives: Behavioral: Online screening and feedback; Behavioral: Online booklet. |
| Extended follow-up | Experimental | Receives two interventions:
1. Online screening and feedback.
2. Online multi session follow-up. Receives: Behavioral: Online screening and feedback; Behavioral: Online multi session follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of standard alcohol units consumed during the previous seven days
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: measures six months after baseline (enrollment)
Secondary outcomes (5)
Sick leave during last week
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.
Measured: Assessed at six months post baseline
Negative consequences of alcohol consumption
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.
Measured: Assessed at six months post baseline
Change in alcohol consumption
The change score for weekly consumption, from baseline to six months, is calculated based on the seven day consecutive measure (primary outcome).
Measured: Six months post baseline
Number of days with alcohol consumption
Based on the seven day consecutive measure (primary outcome), the number of days with alcohol consumption is calculated.
Measured: Six months post baseline
Number of alcohol binges
Based on the seven day consecutive measure (primary outcome), the number of days with a binge drinking episode is calculated.
Measured: Six months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hazardous DrinkingStudies 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
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Håvar Brendryen, University of Oslo
- Investigators
- Håvar Brendryen, PhD, Principal investigator, Norwegian Centre for Addiction Research, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754090
- Sponsor's protocol ID
- SERAF-BALANCE-1
- Status last verified
- Sep 2017
- First submitted
- 17 Dec 2012
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Brendryen H, Lund IO, Johansen AB, Riksheim M, Nesvag S, Duckert F. Balance--a pragmatic randomized controlled trial of an online intensive self-help alcohol intervention. Addiction. 2014 Feb;109(2):218-26. doi: 10.1111/add.12383. Epub 2013 Nov 21.
PubMed 24134709
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".
- ClinicalTrials.gov ID
- NCT01754090
- Acronym / sponsor ID
- SERAF-BALANCE-1
- Conditions
- Hazardous Drinking, Harmful Drinking
- Keywords
- alcohol, online intervention, hazardous drinking, harmful drinking, early intervention, behavior change intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Dec 2012 (estimated)
- 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 purpose of this study is to test whether an online multi session alcohol intervention improves treatment effect compared to single session screening with feedback only.
All participants in the trial received a single session screening procedure including individualized normative feedback (usual care). Additionally, half of the participants received a simple online booklet about the effects of alcohol. The other half received an online multi session follow up program.
Detailed description
Aims: Test whether a multi session alcohol intervention improves treatment effect (i.e., reduced consumption of alcohol) compared to single session screening with feedback.
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" .
Setting: Online study in Norway. Participants: At-risk drinkers is recruited through internet advertisements and randomly assigned to one of two conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Online screening and feedback, Behavioral: Online booklet.Receives two interventions: 1. Online screening and feedback. 2. Online booklet. |
| Extended follow-up | Experimental | Behavioral: Online screening and feedback, Behavioral: Online multi session follow-upReceives two interventions: 1. Online screening and feedback. 2. Online multi session follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hazardous or harmful drinking (i.e., a FAST-score of 3 or more)
Key exclusion criteria (3 listed)
- underage (<18)
- not provided a valid e-mail address
- not provided a valid (Norwegian) mobile phone number
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 |
|---|---|---|
| Online screening and feedbackAn online single session screening procedure including individualized normative feedback. | Behavioural | Extended follow-up, Usual care |
| Online booklet.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 | Behavioural | Usual care |
| Online multi session follow-upAn 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). | Behavioural | Extended follow-up |
Primary outcome
number of standard alcohol units consumed during the previous seven days
Time frame: measures six months after baseline (enrollment)
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.
5 secondary outcomes
Sick leave during last week
Time frame: Assessed at six months post baseline
Negative consequences of alcohol consumption
Time frame: Assessed at six months post baseline
Change in alcohol consumption
Time frame: Six months post baseline
Number of days with alcohol consumption
Time frame: Six months post baseline
Number of alcohol binges
Time frame: Six months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Background: PubMed 24134709Brendryen H, Lund IO, Johansen AB, Riksheim M, Nesvag S, Duckert F. Balance--a pragmatic randomized controlled trial of an online intensive self-help alcohol intervention. Addiction. 2014 Feb;109(2):218-26. doi: 10.1111/add.12383. Epub 2013 Nov 21.
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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.
Håvar Brendryen, PhD principal investigator
Norwegian Centre for Addiction Research, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online screening and feedback, Online booklet. and Online multi session follow-up in people with Hazardous Drinking and Harmful Drinking, run by University of Oslo 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 3 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: finished, as of the sponsor's last update on 11 Sep 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of standard alcohol units consumed during the previous seven days (time frame: measures six months after baseline (enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754090, which also lists 1 linked publication.
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 11 Sep 2017.