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
  Purpose

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.


Condition Intervention Phase
Problematic AOD Use
Behavioral: eScreen
Behavioral: Alkoholhjalpen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of eScreen for Problematic Alcohol Use

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 633
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Experimental: Web based self-monitoring 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
Active Comparator: Web based self-help 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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544803

Locations
Sweden
Karolinska Institutet, Department of Clinical Neuroscience
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Anne H Berman, PhD Karolinska Institutet
  More Information

Additional Information:
Publications:
Responsible Party: Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01544803     History of Changes
Other Study ID Numbers: 2008/308-31/5A
Study First Received: October 27, 2011
Last Updated: March 5, 2012
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Keywords provided by Karolinska Institutet:
Randomized Controlled Trial
Alcohol
Internet
Screening
Brief intervention
Personalized feedback

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014