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Randomized Controlled Trial of eScreen for Problematic Alcohol Use

Primary Purpose

Problematic AOD Use

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
eScreen
Alkoholhjalpen
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Problematic AOD Use focused on measuring Randomized Controlled Trial, Alcohol, Internet, Screening, Brief intervention, Personalized feedback

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet, Department of Clinical Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Control group

Web based self-monitoring

Web based self-help

Arm Description

Outcomes

Primary Outcome Measures

Change in the total AUDIT-C score
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
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).

Full Information

First Posted
October 27, 2011
Last Updated
March 5, 2012
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01544803
Brief Title
Randomized Controlled Trial of eScreen for Problematic Alcohol Use
Official Title
Randomized Controlled Trial of eScreen for Problematic Alcohol Use
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problematic AOD Use
Keywords
Randomized Controlled Trial, Alcohol, Internet, Screening, Brief intervention, Personalized feedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
633 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
Web based self-monitoring
Arm Type
Experimental
Arm Title
Web based self-help
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
eScreen
Other Intervention Name(s)
www.escreen.se
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Alkoholhjalpen
Other Intervention Name(s)
www.alkoholhjalpen.se
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the total AUDIT-C score
Description
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.
Time Frame
3, 6 and 12 months
Secondary Outcome Measure Information:
Title
AUDIT
Description
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
Time Frame
3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Department of Clinical Neuroscience
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
20092953
Citation
Sinadinovic K, Berman AH, Hasson D, Wennberg P. Internet-based assessment and self-monitoring of problematic alcohol and drug use. Addict Behav. 2010 May;35(5):464-70. doi: 10.1016/j.addbeh.2009.12.021. Epub 2010 Jan 4. Erratum In: Addict Behav. 2010 Sep;35(9):853.
Results Reference
background
PubMed Identifier
21030164
Citation
Sinadinovic K, Wennberg P, Berman AH. Population screening of risky alcohol and drug use via Internet and Interactive Voice Response (IVR): a feasibility and psychometric study in a random sample. Drug Alcohol Depend. 2011 Mar 1;114(1):55-60. doi: 10.1016/j.drugalcdep.2010.09.004. Epub 2010 Oct 27.
Results Reference
background
Links:
URL
http://ki.se/
Description
For research group profile search Berman
URL
http://www.escreen.se
Description
Web based self-monitoring site
URL
http://www.alkoholhjalpen.se
Description
Web based self-help site

Learn more about this trial

Randomized Controlled Trial of eScreen for Problematic Alcohol Use

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