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Completed

NCT Number: NCT01754090

Testing the Efficacy of an Online Alcohol Intervention

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.

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Key information

Conditions

Hazardous Drinking Harmful Drinking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian Centre for Addiction Research, University of Oslo

Oslo, 0315, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online screening and feedback

Behavioral

An online single session screening procedure including individualized normative feedback.

Online booklet.

Behavioral

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-up

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Change in alcohol consumption

    Time frame: Six months post baseline

    The change score for weekly consumption, from baseline to six months, is calculated based on the seven day consecutive measure (primary outcome).

  4. Number of days with alcohol consumption

    Time frame: Six months post baseline

    Based on the seven day consecutive measure (primary outcome), the number of days with alcohol consumption is calculated.

  5. Number of alcohol binges

    Time frame: Six months post baseline

    Based on the seven day consecutive measure (primary outcome), the number of days with a binge drinking episode is calculated.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2012
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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