Problematic AOD Use Clinical Trial
Official title:
Randomized Controlled Trial of eScreen for Problematic Alcohol Use
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.
| Status | Completed |
| Enrollment | 633 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska Institutet, Department of Clinical Neuroscience | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet |
Sweden,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | AUDIT | Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems). | 3, 6 and 12 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02064998 -
Two Consecutive Randomized Controlled Trials Using Mobile Phone Applications for Risky Alcohol Use
|
N/A | |
| Completed |
NCT01532388 -
Randomized Controlled Trial of eScreen for Problematic Drug Use
|
N/A |