Randomized Controlled Trial of eScreen for Problematic Alcohol Use
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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 |
- 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.
- 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 |
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| Sweden | |
| Karolinska Institutet, Department of Clinical Neuroscience | |
| Stockholm, Sweden, 17176 | |
| 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 May 16, 2013