Clinical trial NCT01544803: Randomized Controlled Trial of eScreen for Problematic Alcohol Use
Official title: Randomized Controlled Trial of eScreen for Problematic Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Problematic AOD Use
Keywords: Randomized Controlled Trial
Alcohol
Internet
Screening
Brief intervention
Personalized feedback
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 633
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the total AUDIT-C score
timeFrame: 3, 6 and 12 months
Secondary outcomes:
measure: AUDIT
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Clinical Neuroscience
Study officials:
affiliation: Karolinska Institutet
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.