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Testing the Efficacy of an Online Alcohol Intervention

Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention Balance.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01754090
Enrollment
244
Registered
2012-12-21
Start date
2011-04-30
Completion date
2012-06-30
Last updated
2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Harmful Drinking, Hazardous Drinking

Keywords

alcohol, online intervention, hazardous drinking, harmful drinking, early intervention, behavior change intervention

Brief 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). 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.

Interventions

An online single session screening procedure including individualized normative feedback.

BEHAVIORALOnline 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

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).

Sponsors

The Research Council of Norway
CollaboratorOTHER
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
number of standard alcohol units consumed during the previous seven daysmeasures 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.

Secondary

MeasureTime frameDescription
Sick leave during last weekAssessed at six months post baselineSick 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.
Negative consequences of alcohol consumptionAssessed at six months post baselinePerceived 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.
Change in alcohol consumptionSix months post baselineThe change score for weekly consumption, from baseline to six months, is calculated based on the seven day consecutive measure (primary outcome).
Number of days with alcohol consumptionSix months post baselineBased on the seven day consecutive measure (primary outcome), the number of days with alcohol consumption is calculated.
Number of alcohol bingesSix months post baselineBased on the seven day consecutive measure (primary outcome), the number of days with a binge drinking episode is calculated.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026