NCT01544803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
633

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

October 27, 2011

Last Update Submit

March 14, 2025

Conditions

Keywords

Randomized Controlled TrialAlcoholInternetScreeningBrief interventionPersonalized feedback

Outcome Measures

Primary Outcomes (1)

  • 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.

    3, 6 and 12 months

Secondary Outcomes (1)

  • AUDIT

    3, 6 and 12 months

Study Arms (3)

Control group

NO INTERVENTION

Web based self-monitoring

EXPERIMENTAL
Behavioral: eScreen

Web based self-help

ACTIVE COMPARATOR
Behavioral: Alkoholhjalpen

Interventions

eScreenBEHAVIORAL

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.

Also known as: www.escreen.se
Web based self-monitoring
AlkoholhjalpenBEHAVIORAL

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.

Also known as: www.alkoholhjalpen.se
Web based self-help

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Drug use DUDIT\>0
  • Unproblematic alcohol use, AUDIT\<8 for men and AUDIT\<6 for women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Department of Clinical Neuroscience

Stockholm, 17176, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 20092953BACKGROUND
  • 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.

    PMID: 21030164BACKGROUND

Related Links

Study Officials

  • Anne H Berman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 27, 2011

First Posted

March 6, 2012

Study Start

September 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2011

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations