Randomized Controlled Trial of eScreen for Problematic Alcohol Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01544803
First received: October 27, 2011
Last updated: March 5, 2012
Last verified: February 2012

October 27, 2011
March 5, 2012
September 2009
October 2010   (final data collection date for primary outcome measure)
Change in the total AUDIT-C score [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
The primary outcome measure for this trial was the change in the total AUDIT score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
Same as current
Complete list of historical versions of study NCT01544803 on ClinicalTrials.gov Archive Site
AUDIT [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial of eScreen for Problematic Alcohol Use
Randomized Controlled Trial of eScreen for Problematic Alcohol Use

Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. A more extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum.

Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: T1, eScreen referral (n=211); T2, Alkoholhjalpen referral (n=211); Control group (n=211). Outcomes on alcohol use as well as health-related symptoms are assessed after 3, 6 and 12 months.

The first hypothesis is that all three groups will reduce their alcohol consumption and alcohol-related problems at follow-ups compared to the baseline level. The second hypothesis is that there will be no differences between participants in the eScreen and the Alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at follow-ups. The third hypothesis is that participants in the eScreen and the Alkoholhjalpen group will show a greater reduction in alcohol consumption and alcohol-related problems compared to the control group (no intervention) at follow-ups. For a greater understanding of the study results possible other interventions received by the study participants for their problematic alcohol use during these 12 months of study participation will be investigated.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Problematic AOD Use
  • Behavioral: eScreen
    The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels.
    Other Name: www.escreen.se
  • Behavioral: Alkoholhjalpen
    An extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum.
    Other Name: www.alkoholhjalpen.se
  • No Intervention: Control group
  • Experimental: Web based self-monitoring
    Intervention: Behavioral: eScreen
  • Active Comparator: Web based self-help
    Intervention: Behavioral: Alkoholhjalpen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
633
October 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Problematic alcohol use. AUDIT>7 for men and AUDIT>5 for women

Exclusion Criteria:

  • Drug use DUDIT>0
  • Unproblematic alcohol use, AUDIT<8 for men and AUDIT<6 for women
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01544803
2008/308-31/5A
No
Anne H Berman, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Anne H Berman, PhD Karolinska Institutet
Karolinska Institutet
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP